clinical research associate formation

Society of Clinical Research Associates

• Courses & Conferences

Become a Member

• Find a Local Chapter

Upcoming Conferences and Courses

Clinical research never stops advancing, neither should you..

Clinical Trials Day 

SOCRA is an organization comprised of members who are shaping our profession and impacting clinical research with quality and excellence. You are the people who have dedicated your careers to improving public health for the world population. As medical professionals, you have been carrying on research activities, treating patients, saving lives, and making discoveries. Each year on May 20th we take a few moments to honor your invaluable contributions to advancing the field! Join us in the celebration!

In Person Conferences + Workshops 

Human Research Protections May 16 & 17, 2024 | Scottsdale, AZ

Project / Program Management May 16 & 17, 2024 | Scottsdale, AZ

See All Upcoming Events

Featured Courses

Fda clinical trial requirements regulations, compliance and gcp conference.

New Orleans, LA November 6 & 7, 2024

This two-day conference is intended to share information among FDA representatives and the regulated community, to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience. The program will focus on the relationships among the FDA and clinical trial staff, investigators and IRBs.

Quality Management Conference

Chicago, IL October 24 & 25, 2024

This conference provides attendees with new information, tools, and real life examples to help participants navigate the components of quality management in clinical research - quality planning, quality control, quality assurance, and quality improvement.

Belonging to SOCRA provides you with the information and resources you need to advance your career and enhance your professionalism.

• 15,100+ Members
• 11,300+ "CCRP" Certified Clinical Research Professionals
• 34 education programs held in 2022

Learn More About Membership

Recent Blogs

17th annual device research & regulatory conference: navigating innovation and compliance .

The 17th Annual Device Research & Regulatory Conference is just around the corner, and it promises to be an enlightening... Read More >>

Unlock the Future of Clinical Trials at SOCRA’s First-Ever DCT Conference This April

Jessica Rowe, MA, MS, CCRP, CIP SOCRA President Join us April 4-5, 2024, for this new program on Decentralized Clinical... Read More >>

Inside the 2024 SOCRA Oncology Clinical Trials Conference: Insights from Program Chairs Tammy Neseth & Susanna Sellmann 

Tammy Neseth MA, CCRP, CIP Susanna Sellmann RTT, BS, CCRP Oncology Clinical Trials Conference I March 13-15, 2024 I San... Read More >>

Our Mission

In order to promote quality clinical research, to protect the welfare of research participants, and improve global health, SOCRA's mission is:

To establish educational programming and provide continuing education for clinical research professionals To establish an internationally recognized certification program for clinical research professionals (CCRP®) To foster the professional development and peer recognition of clinical research professionals

SOCRA's Vision That all clinical research fully protects every research participant and is accomplished with excellence, quality, and professionalism.

Clinical Research Associate

Clinical Research Associate Certification

Demo Clinical Research Associate Certification

CRA Training

CCRPS CRA Graduates obtained many job roles including:

Clinical Research Associate, Clinical Trial Monitor II, Research Associate, CRA II, Scientist, Quality Assurance Analyst, Senior Clinical Research Associate, Research Associate in Discovery Immunology, Clinical Trial Monitor/CRA, Clinical Trials Project Manager, Associate Director of Research Nursing, Clinical Trial Navigator, Clinical Director for R&D, Senior Clinical Research Associate, Clinical Research Professional, Medical Science Liaison, Clinical Trial Associate III, Quality Assurance Associate II, IRB/SRC Analyst II, Project Manager, Clinical Trial Associate, Clinical Research Coordinator, Public Health Advisor, Associate Scientist II, Strategy Analyst, Clinical Research Associate II, Clinical Operations Specialist, Advisor - Development Clinical Research Scientist, Neuroscience, Associate Clinical Engineer, Clinical Trial Management Associate, Quality Supervisor, Clinical Research Data Coordinator (2024 CCRPS Graduate LinkedIn Survey).

Clinical Research Associate Training

Advanced clinical research associate certification (acrac), introduction.

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

Roles and Relationships in Clinical Trials

Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Communication between Blinded and Unblinded Staff

Contract Research Organizations (Delegation, Responsibilities, Management )

Sponsor and Investigator Roles

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

ICH GCP - Overview

An Introduction to Clinical Research

An Overview of ICH GCP

ICH GCP - Ethical Research in Vulnerable Populations

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Prisoners

Ethics of Research Involving Pregnant Women and Fetuses

Adverse Events

Advanced Review of Adverse Events

Clinical Trial Protocol

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

IRB and DSMB

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Review Questions

REVIEW: Review Questions for ICH GCP (for study purposes, not graded)

Site Monitoring Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site Qualification Visit (SQV)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Site Initiation Visit (SIV)

Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"

Routine Monitoring Visit (RMV)

Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)

Site Close-Out Visit (SCOV)

Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)

Tools for Monitoring Visits

Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)

Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

FDA Bioresearch Monitoring Program (BIMO)

FDA Warning Letter

Audits and Inspection Review Questions (for study purposes, not graded)

REVIEW A: Quality Monitoring Review Questions (for study purposes, not graded)

SDV and Informed Consent

ICH GCP Section 4.8 Informed Consent

Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)

Minimizing Source Data Queries In Clinical Trials

Case Report Form

Guidelines for Designing and Completing Case Report Forms

Do’s and Don’ts of a Case Report Form Design

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

ICH GCP - Trial Management, Data Handling, and Record Keeping

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Clinical Trial Management System-CTMS

Electronic Data Capture and Remote Data Capture Basics

Electronic Regulatory Submission and Review

Modernized Monitoring (Remote, Risk-based, Centralized)

An Overview of Remote Monitoring - COVID-19 Update

Remote Monitoring of Clinical Trials and EMRs

Centralized Monitoring

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

REVIEW PART B: Quality Monitoring Review Questions (for study purposes, not graded)

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

CFR 21 Part 11 - Electronic Signatures

Code of Federal Regulations

CFR 21 Part 11

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

Regulatory Training Quiz

Disclosures and Payments for PI, Site, Patients

Financial Disclosure- Duties and Strategies for Clinical Studies

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Misconduct and Fraud

Scientific Misconduct and Fraud

Detecting Falsification

REVIEW PART C: Quality Monitoring Review Questions (for study purposes, not graded)

Site Visit Templates

SQV Checklist

SQV Questionnaire

SQV Assessment

SQV Follow Up Letter

SIV Confirmation Letter

RMV Confirmation Letter/Fax

RMV Follow Up Letter

CRA TRANSITION Letter/Email/Fax

SCOV Confirmation Letter

SCOV Agenda

SCOV Report

SCOV Follow Up Letter

REFERENCE Module

Final Examination

Competency Exam

Start Today

• Monitor Trial Sites
• Preferred 4 Year Science Degree or RN License or Prior CRC
• Salary $60-120k+. High promotion rate.

View CCRPS Clinical Research Associate Graduate Case Studies April 2024

Enjoyed Clinical Research Training through Examples  “The real-world examples used throughout the course were incredibly useful for applying theory to practice.”  -Marta Marszalek  ( view full case study )

Case Summary:  Marta Marszalek completed the  CRA certification course seeking to deepen her theoretical knowledge and practical skills in clinical research to complement her monitoring activities and comply with industry standards.  Marta appreciated the self-assessment opportunities, which helped identify areas that needed review. Adding the certification to her CV and LinkedIn profile significantly increased her marketability and helped secure new job opportunities,  affirming the practical benefits of the course. 

From International CRC to U.S. Lead CRC and CRA:   “The flexible online format allowed me to balance my studies with my professional commitments seamlessly.” -  Aishwarya Sukumar  ( view full case study )

Case Summary:   Aishwarya Sukumar completed the CCRPS CRA certification course to enhance her understanding of FDA regulations and adapt to the clinical trials industry in the United States after relocating from abroad.   Chose the CCRPS program for its  affordability and flexibility , crucial as she was adjusting to new motherhood and transitioning careers in a new country . Successfully transitioned from a CRC to a Lead CRC, and then to a CRA role , underscoring the significant career advancement facilitated by the course.  The course facilitated a  smooth transition into the clinical research field in the U.S. , providing her with necessary certifications and boosting her credibility in job interviews.

  From IMG to securing roles as a CRC, CRA, and now a project manager:  “Joining this course was a pivotal step in my career advancement.”  - Dr. Vrushali Borawak  ( view full case study )

Case Summary:   Dr. Borawake successfully transitioned from medicine in India to clinical research in Germany, attributing significant career advancements to the CCRPS CRA training.  She secured positions as a Clinical Research Associate (CRA), and has recently advanced to a Project Manager role.  The courses  provided her with essential knowledge and confidence, particularly in job interviews , by familiarizing her with industry-specific terminology and documentation. Dr. Borawake highlighted the c ourse's effectiveness for international medical professionals  seeking to enter the clinical research field in Germany or other countries, noting its comprehensive coverage of relevant regulations and practical applications .

From Masters in Health Safety to Clinical Research Associate:   " I will say quality of delivery, quality of the materials.   - Ossai Opene  ( view full case study )

Case Summary:  Ossai appreciated the straightforward,  easy-to-follow video presentations  and found the sample questions at the end of each module particularly useful for reinforcing learning.  He found the roles and connections between CROs and CPIs most engaging and informative, providing  clear insights into the clinical research operation landscape . Ossai would recommend the course based on the quality of materials, self-paced format, and positive testimonials  from other learners. The course equipped Ossai with the necessary skills and knowledge to transition into clinical research, enhancing his understanding of industry standards and practices.

From Grant Program Manager to Leading Clinical Trials at UCSF :  "it really did a great job of the full scope of clinical research from start to finish. Since completing the course, I've received a promotion at work. "  -Hannah Fischer  (view HF clinical research training case study)

Case Summary:   Before CCRPS, Hannah Fischer Was A Grant Manager having difficulties with Clinical Trial Coordination . After CCRPS She Elevated to Clinical Trial Leader at UCSF, Excelling in Trial Management and Grant Applications. T he certification and the knowledge gained from  the course played a crucial role in Hannah securing a promotion at work , illustrating the career enhancement potential of the program. The content was comprehensive and directly applicable to her current role in managing clinical trials, significantly aiding her daily responsibilities and strategic approach.  Hannah  actively recommended the CCRPS program to her colleagues, emphasizing its thorough approach to explaining the clinical trial process from start to finish.  Her endorsements highlight the program’s applicability and value across her professional network.

Enroll Schedule Advising

CCRPS Reviews

Cra certification, detailed information, oladipo owoyomi.

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, hi...

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, highly inspiring. I recommend it for anyone with a research drive.

Lifechanging for my career

Latoya munroe.

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experienc...

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experience as I was introduced to Clinical Research Associate Certification. Hoping to build a career through this. Awesome experience

Amazing all inclusive course

David narouz.

The test was ever hard, I have studied and passed the CRA in 1 month of intensive study and would encourage anyone to take it.

Extremely well presented CRA course!

Abiodun babayeju.

This course is detailed, well presented, and provides all you need to become a confident CRA!

Fantastic tool to expand my CV

Marquise jeffery, kenny adazie, my thoughts, tondor cleopatra uzosike.

A very educative Course. Highly recommended

It is an excellent presentation with good speed in clear...

Cynthia zhao, patient recruiting and retaining, lynda agboola.

not too long but precise

Phd In Monitoring

Adriana paz mancia.

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to ...

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to life through discovery and application. So many topics are covered almost like a bootcamp for phd in trials.This is helpful

Subhash Soni

Good to understand, temitope oshineye, accelerated, zehra abbas.

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with histo...

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with history background and by other as well with thehelo of the slides.

a fundamental stepping stone for all monitors

George grudziak.

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn ...

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn what is covered in just a chapter. I refer back to the course every time I switch to a new trial to refresh my knowledge.

Mary Dahodu

Great course with high knowledge impaction. Platform also was easy to navigate.

Dedication to real material

Asra feroze.

The diligence and direction provided by this course material has inspired my inner confidence to climb high to reach the pinnacle of my ambitions.

Refreshed my knowledge after 10 years in monitoring

Dr. sharib syed muhammad.

Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.

CCRPS trains monitors to succeed in remote and local site...

Esohe ayanru.

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to m...

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to move up. This course was so advanced and really made sure you understood all the core guidelines and monitoring report processes. It made me feel much more comfortable when applying for new jobs.

two weeks to update your resume

Shivani dhotre.

CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.

A great review of clinical research for monitors

Jayant shrivastava.

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lo...

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lots of templates in each module for SIV and other things which I really liked.

Learn by examples. Great follow through videos.

Abiodun adegbite.

Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.

Remarkabley accurate lectures that go into so many reason...

Vaishnav nath ajeendra nath.

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quit...

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quite a lot of foundation and practical skills. This was an absolute wonderful learning experience on this platform, thanks for the assistance and hope to continue to learn from this experience, thank you...

ACRA Training

Ossai a opene.

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get int...

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get into the CRA space.

Gertrude Nenanya

Detailed and Informative. A lot to take in yet rich with step-by-step information to prepare anyone new to clinical research

clinical research associate

Khalel imanbayev, sathya ramamoorthy, best way to start a new career as an img.

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career ch...

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career change and honestly everything made sense so I felt like I really understand and enjoyed the material! You don’t need a science background to take this.

Knowledgeable

Norah okafor.

It has really been of great impact with my 5 years experience as a CRC.

Very good content

Great course for updating information and knowledge

Mohammad ismail, dr. jennifer campbell-allman, dr. jennifer campbell-allman, phd. msc., rmhci., very detailed information, goliath sakala.

This course is very detailed and informative.

Only resource CRAs need

Husnain arshad.

Very interesting and useful for CRA training

Advance Clinical Research Associate

Charity oparah, acrac review, cyprian suh.

Very, very enriching; content and presentation.

It is informative

Safeyeh alghazali, adeyinka balogun agesin, its a great opportunity for me to review again all aspect..., adam friday.

EXCELLENT EXPERIENCE

Loving my training!

Corinthia mims.

I really appreciate the ability to return to a section to observe again. I like being able to take my time to learn.

Sergiy Ivashchenko

Very Good Course

CRA Training Program

CRAs monitor clinical trial sites for compliance with guidelines and protocols. Salary of $60k to 120k+ based on experience level.

Requirement

A minimum of 4 year degree in science required though scientists, IMGs, nurses, prior coordinators, and even senior CRAs take our course.

Takes 2-4 weeks. Start today. Self-paced. 3k+ enrollees choose us because of our advanced curriculum with practice applications and competitive pricing.

Certification

Triple-accredited course with 17.5 CME. Achieve 70% on 2 attempts on MCQ exam.

How to become a clinical research associate

To become a clinical research associate, you must first complete an accredited clinical research associate training program. The course provides an extensive review of the regulations and principles of clinical research, as well as practical application of the skills needed to execute and manage trials correctly.

Clinical research associate certification test covers topics like clinical research protocols, FDA regulations, Good Clinical Practice (GCP), ICH guidelines, data management and more. If you pass the exam, it means you're certified as a CRA.

You can get clinical research associate training online free with webinars, tutorials, eBooks and other materials related to the profession. This can help you learn more about the job before you get certified.

What is a clinical research associate

A CRA makes sure clinical trials are done correctly and on time. They make sure the clinical trial follows the plan, good clinical practice guidelines, ethics, and laws. CRA's must know a lot about trial protocols, patient safety, data integrity and regulatory requirements to guarantee the quality of a clinical trial.

Clinical Trial Associate

A clinical research monitor will review study sites' data collection processes to ensure that all data collected is complete and accurate. This includes conducting on-site visits to assess study sites' compliance with good clinical practices (GCP), review case report forms (CRF), and periodically audit research sites to ensure compliance.

Clinical Trial Monitoring

Clinical research associates do things like teach the protocol; talk to human subjects and their families; get ready for investigator meetings, trainings, documentations; manage study supplies inventory; track subject enrollment, visits, data reports, study timelines; and solve any problems that come up during the study.

Why get clinical research associate training

Clinical trial monitoring job growth.

Getting certified as a Clinical Research Associate (CRA) gives you the opportunity to start earning salaries of up to $100,000 and 33% of new CRAs receive promotions within the first year.

Clinical research association accreditation

The ACRAC training program is internationally accredited by industry standards including IAOCR, ACCRE, AMA, ACPE, ANCC to provide comprehensive training for those holding at least a BA in Science.

Fast track clinical research training

Flexible online training and on-demand video modules that can be completed in as little as 2 weeks for a clinical research associate fast track career.

Clinical Research Associate Salary

Salary for clinical research associate

Clinical research associate salary (CRA) is typically higher than the national average and varies depending on experience, job title, city of employment and industry. The average annual salary for a CRA was estimated to be $80,000 in 2024.

Entry-level clinical research associate salaries can range from $47,000 - $80,000 per year. As a CRA gains more experience and furthers their education, they may be able to negotiate higher salaries due to their valuable knowledge and skills.

can exceed $90,000 in certain geographies or with specialized skillsets. Generally speaking, the higher the level of education or specific certifications held by a CRA, the higher salary they can expect to earn.

Various factors impact how much a CRA can earn such as their employer’s size and industry sector (pharmaceuticals vs biotechnology companies), amount of travel required for research responsibilities and tasks assigned.

Clinical research associate job description

What does a clinical research associate do

Developing Protocols and Case Report Forms

The Clinical Research Associate is responsible for creating clinical research protocols and Case Report Forms. This includes writing instructions, outlining procedures, collecting data, assessing collected samples/specimens, and making sure people follow the protocol/investigational plan.

Monitoring Clinical Study Sites and Teams

The CRA role includes making sure that sites are monitored, data is accurate, and reviewing source documents. They also manage a team of physicians, nurses, support staff (if applicable), vendors (such as laboratories) involved in the clinical trial and providing training on protocol requirements in order to achieve successful outcomes from each trial/study conducted.

Ensuring Regulatory Compliance

CRAs need to make sure they follow all the rules and regulations for conducting studies. This includes making sure the studies are safe for patients, ethical, and accurate. CRAs also need to attend regular meetings with people who are involved with the study to discuss any changes in the rules or regulations that could affect how the study is conducted.

Clinical Research Associate Jobs

How to obtain a CRA job

Utilize online job boards, such as Indeed and Glassdoor, to search for open positions. When searching, use keywords such as "clinical research associate jobs", "clinical research associate job", "clinical research associate jobs entry level" and "remote clinical research associate jobs". Make sure to write a cover letter.

To find potential employers as a Clinical Research Associate, look in directories of medical companies or local businesses.Contact the employer by email or phone and tell them why you would be good for the job they are trying to fill.

Talk to people who have jobs like the one you want, follow professional organizations on LinkedIn, and go to events where you can meet these people. This way, you might hear about job openings.

Check social media for job postings by following accounts related to Clinical Research Associates and checking them regularly for new postings that might be a good fit for you.

Clinical Research Associate Certification FAQs

Clinical research associates (CRAs) are professionals who work in the pharmaceutical and healthcare industries to manage clinical trials and collect evidence. The primary role of a CRA is to ensure that all clinical trials and research studies are conducted according to legal requirements, ethical standards, and good clinical practices. CRAs interact with other healthcare professionals, researchers, patients, and sponsors to coordinate activities related to the trial. A successful CRA must have a strong background in science and medicine, as well as solid communication skills. Candidates for CRA jobs typically undergo training on Good Clinical Practices (GCP) prior to beginning their job duties. Clinical research associate roles include but are not limited to recruiting subjects for studies; designing protocols; performing administrative tasks such as budgeting; coordinating data collection; providing feedback on documents; conducting site visits; monitoring safety reports; reviewing patient records; preparing reports; analyzing data from clinical trials; maintaining records of trial progress; managing study databases; and developing clinical trial databases.

1) Spearhead the planning, implementation and evaluation of clinical studies by preparing study protocols, developing case report forms and managing data collection. This includes creating regulatory documents such as informed consent forms, patient diaries and Investigator's Brochures. 2) Monitor study progress with sites to ensure compliance with protocol requirements and regulations, such as Good Clinical Practice (GCP). Review raw data, verify accuracy and completeness of case report forms, analyze data using statistical software packages and participate in final report preparation. 3) Participate in the selection of sites for trials while maintaining professional working relationships with investigators. Generate metrics from study results and attend investigator meetings to provide target product profiles/project plans that align with organizational objectives.

1) Prepare study documents such as protocols, informed consent forms, case report forms and investigator brochures 2) Monitor sites to ensure compliance with study objectives, protocol requirements, good clinical practices (GCPs) and applicable governmental regulations 3) Ensure the accuracy of subject enrollment, data collection and handling processes 4) Oversee the maintenance of accurate source documents and regulatory binders 5) Manage investigator payments according to contract terms 6) Train site personnel on protocol and GCPs requirements 7) Track necessary regulatory documents such as licensure/DEA/IRB approvals; resolve any related issues with IRBs or other regulatory agencies. 8) Lead study start up activities including sending out essential materials to sites, distributing and completing required training for staff members; verifying that site initiation visits are completed timely 9) Prepare monitoring plans in consultation with the sponsor or CRO leadership; perform pre-study, initiation, interim and closeout visits at investigative sites as per study timelines. 10) Perform remote monitoring activities by regularly reviewing case report forms (CRFs), checking query log resolution status from sites. 11) Provide guidance on data entry queries from clinical research coordinators (CRCs) or other site personnel. 12) Monitor safety events reported by sites; notify appropriate parties promptly regarding serious safety events or protocol deviations. 13) Ensure that all adverse event reports are followed up for completion by review of medical records. 14) Generate routine visit reports using standard CRF formats; track budgets for each site according to protocol specific requirements & perform final reconciliation of monies within sponsor's payment system.

1) In order to become a Certified Clinical Research Associate (CRA) with CCRPS CRA certification, the first step is to research and obtain an undergraduate degree in any field related to clinical research, such as public health, healthcare administration or epidemiology. 2) Prospective CRAs should strive to gain experience in a clinical research setting through volunteer positions or internships within hospitals, clinics, universities or pharmaceutical companies. 3) The next step is to take and successfully pass the Certified Clinical Research Associate (CRA) exam offered through the Certified Clinical Research Professional Society (CCRPS). This comprehensive examination covers topics such as Good Clinical Practice (GCP), study design and implementation, regulatory compliance and ethics.

•CCRAs have a more standardized set of skills, which can help with advancing their career and obtaining higher salaries. • Becoming a CCRA provides greater opportunities for job advancement and the potential to improve salary. • Additionally, CCRA certification is a great way to demonstrate expertise, stay on top of industry developments, network within the field, and have access to exclusive resources.

1) Become an expert in clinical research studies. Take the time to learn as much as possible about different types of trials, protocols and procedures, as well as the regulations governing clinical research. Additionally, take advantage of any available continuing education opportunities and seminars to stay up-to-date on the latest developments in the field. 2) Develop strong organizational skills to effectively manage multiple studies, sites and deadlines. Create a system for tracking tasks and deliverables so that nothing falls through the cracks – this will keep sites, sponsors and investigators happy and maintain your reputation for excellence. 3) Establish yourself as a reliable source for knowledge both inside and outside your organization. Keep abreast of current trends in the industry so you can offer advice to others or answer their questions promptly; gain recognition by authoring publications or presenting at industry events; and always make sure your work is accurate and follows all applicable regulations.

1. PRA Health Sciences: A global biopharmaceutical organization that provides contract research services and drug development solutions to pharmaceutical, biotechnology, and medical device companies. 2. Syneos Health: A clinical services organization delivering integrated, tailored solutions to help customers accelerate the delivery of therapies to market with confidence. 3. IQVIA: A leading provider of integrated information and technology solutions for healthcare and life sciences organizations, helping them drive efficiency and effectiveness across all aspects of their business. 4. ICON Clinical Research: Providing strategic development advice and clinical trial execution services from a network of highly qualified site personnel across 63 countries. 5. Covance: A contract research organization (CRO) providing drug development solutions from laboratory testing services through to large-scale clinical trials in more than 25 countries worldwide 6. Chiltern International Ltd.: An award-winning CRO that offers full-service clinical development capabilities such as legal compliance support, project management, medical writing, data management/statistical analysis, safety/pharmacovigilance monitoring and global regulatory submissions assistance for clients in the US, Europe, Asia Pacific, South Africa and Latin America. 7. BioClinica Clinical Trials Solutions: Offering comprehensive eClinical suite that helps streamline processes related to study design, document management & reporting as well as imaging & safety data collection & review process management in real time around the globe for all types of studies—Sponsor-initiated Protocols (SIPs) or Investigator Initiated Studies (IIS). 8. Worldwide Clinical Trials: An award-winning CRO providing comprehensive clinical trial operations & data management services from initial concept development through final report generation across multiple therapeutic areas including oncology & rare diseases for both early phase studies & late phase trials in over 28 countries around the globe. 9. Clinipace Worldwide Clinical Trials Services: Specializing in creating innovative technology platforms for clinical research by combining its expertise in digital media with its deep understanding of regulatory policies thereby helping reduce complexities associated with managing large scale global projects involving multiple stakeholders from different parts of the world from start to finish – protocol design & buildout; patient enrollment & retention; site training; EDC builds; study closeout activities etc., involving both electronic data capture (EDC) based studies as well as non EDC based studies which can be delivered simultaneously or independently depending upon customer's requirements/goals at any one given point in time during the life cycle of a clinical trial project globally - US/EU/ROW markets etc., while adhering to the highest standards of quality assurance (QA), timelines and budget requirements resulting into improved operational efficiencies on part of our customers leading to better ROI figures towards end results achieved by successful completion of projects within stipulated timelines without compromising on Quality whatsoever!

1. Clinical research associates typically make an average of $53,000 a year, with a range between $45,000 to $62,000 annually. 2. The top 10 percent of clinical research associates can expect to make around $70,000 or more annually. 3. The lowest 10 percent of clinical research associates earn around $40,000 or less per year. 4. Mid-level salaries for clinical research associates usually fall within the range of $50,000 to $60,000 annually. 5. Incentives such as bonuses and commissions can significantly increase overall earnings for experienced clinical research associates. 6. Geographical location is often a factor in determining salaries for this profession; locations that tend to pay more include states like New Jersey, California and Massachusetts as well as metropolitan areas such as Seattle and San Francisco. 7. Other factors that may influence how much a clinical research associate earns include experience level and sector of the industry they are employed in (i.e., government, private or academic). 8. A career in this field offers many opportunities for growth and financial advancement; with additional education or certifications an individual could potentially make upwards of six figures annually after several years of experience in the profession.

Clinical Research Associate Course Syllabus

The CCRPS CRA program contents meets AMA requirements for 17.5 CME. This means that the course can help you succeed in your medical career. Additionally, the introductory chapter introduces you to clinical terminology and abbreviations commonly encountered in clinical research.

As a clinical research associate (CRA), it is important to know how to interact with other stakeholders in order to set up and monitor clinical trials for an investigational product or IP. These stakeholders include the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC), other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

The ICH-GCP guidelines provide procedures and precautions for protecting human research participants during clinical research. These guidelines cover obtaining informed consent from human subjects, maintaining trial records, reporting compliance and progress, as well as procedures for suspending or terminating trials. The chapter also covers the importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

This chapter will teach you about the different phases of clinical trials, from the pre-clinical phase to Phases 0-4. You will learn about important concepts like the structure and goals of each phase, dosing approaches, toxicology testing, and more. The chapter will also review the FDA's drug approval process.

The chapter provides an overview of GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

In chapter 6, we will learn about ethical research involving vulnerable populations. This includes people who are pregnant, children, mentally incapacitated individuals, and prisoners. We will learn about the challenges of conducting research with these groups of people, including obtaining consent from parents or guardians, providing fair incentives, and using deception or incomplete disclosure in a justified way.

This chapter covers the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects.

Chapter 8 is all about clinical trial protocols (CTPs). This chapter goes into detail about what a CTP is and how to write one. It also covers important concepts like study risk benefit analysis (RBA), sample size and statistical power, data analysis, risk management, and study administration. Additionally, the chapter addresses concepts related to choosing participants for the study, including inclusion and exclusion criteria, safety concerns, and ethical considerations.

This chapter will teach you about protocol deviations and violations. You will learn about the different types of deviations and violations, and how to distinguish between them. You will also learn about the most common violations, including minor ones (like off-schedule subject assessments) and major ones (like failure to report AEs). Finally, the chapter will review principles for reporting protocol deviations and IRB approval for planned deviations.

The IRB (Institutional Review Board) and DSMB (Data Safety Monitoring Board) are responsible for reviewing and approving research studies involving human subjects. This chapter reviews the history of these boards, and discusses the principles that guide their decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.

This module provides an overview of different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

This chapter provides a thorough understanding of the stages and steps involved in selecting a study site. The module reviews elements such as the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). It is important to learn about the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.

This module goes into detail about site initiation visits (SIVs). You will learn how to prepare for an SIV, including what approvals, permits, and licenses you need. Additionally, the module covers what should be on the SIV agenda, such as orientation and training for site staff. Finally, you will learn about post-SIV procedures, such as filing compliance documents like FDA form 1572 and Financial Disclosure Form (FDF).

This unit will teach you about routine or periodic monitoring visits. You will learn about the agenda of an RMV, which includes receiving updates on AEs from site staff and overseeing the progress of trials. The unit covers different approaches to site monitoring, including traditional (full-scale) monitoring and risk-based monitoring (RBM). It also compares on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is essential for obtaining accurate data from clinical trials.

This chapter covers everything you need to know about ending or finishing a trial site. This includes things like notifying the IRB and coordinating schedules among site staff (PI, other investigators, medical staff) and the monitoring team (CRC, CRAs, etc.), as well as preparing for an SCOV meeting – drug inventory management, database verification and lockdown, subject notification and completion of all subject-related documents, staff-related documentation, and other administrative tasks like compiling a close-out report.

This unit provides tips and tools to help a CRA (clinical research associate) effectively monitor clinical trials. The chapter lists physical accessories that can be useful for monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions.

This module will help you understand and prepare for audits and inspections by the CRO, FDA, or other regulatory authority. It covers the difference between an audit and an inspection, and provides detailed protocols for both. Additionally, it outlines the sequence of an FDA inspection, including a walk-through of the Biomedical Research Monitoring Program inspection. You will learn about important audit and inspection documents, such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation). You will also learn about the Establishment Inspection Report (EIR) prepared by the auditor/inspector. Finally, you will understand the different types of observations in an EIR, including NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated).

This chapter discusses the ICH-GCP guidelines on obtaining informed consent from subjects. The highlights include the need to use non-technical language, transparently delineate risks, obtain consent without undue influence, obtain consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to ensure that subject trial data (as recorded in Case Report Forms or CRFs) correspond to source data (previous medical records).

This module provides a detailed overview of the structure and elements of a Case Report Form (CRF), including different forms for Principal Investigator (PI) verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events, etc. Additionally, the chapter outlines important data notation rules, such as the use of accepted acronyms (e.g., ‘ND’ for missing data and ‘UNK’ for unknown information), MM-DD-YY format, time-stamp data, etc., as well as guidelines for the design of CRFs (e.g., consistency of notation, avoidance of duplicate data fields).

In this unit, you will learn about Quality Control in clinical trials. This includes understanding what Quality Control is, its relationship with Quality Assurance, using Key Performance Indicators, having a Corrective and Preventive Action plan, and more. Additionally, the module will look at the QA process, focusing on risk-based monitoring and providing guidelines on Quality Metrics. The chapter also reviews ICH-GCP guidelines on subject safety, including risk-benefit assessment and stoppage rules in case of serious adverse events. Finally, it introduces the FDA’s Human Research Protection Program.

This tutorial provides an in-depth look at the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs), including IVRS and IWRS, as well as RTSM systems for Randomization and Trial Supply Management are examined. The benefits of standardized data management and data sharing, approaches to database management, and the concept of an Independent Data Monitoring Committee (IDMC) are reviewed. Critical elements of data integrity, such as proper anonymization and coding, completeness of data, data safety precautions, and logging of site visits and other progress reports are highlighted Essential features of a good Clinical Data Management(CDM) system that complies with FDA CFR Title 21and HIPAA regulation.

This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements.

This unit will teach you about pharmacovigilance (PV), which is the process of monitoring the effects of drugs. You will learn about the statistics on adverse events (AEs), how to distinguish between Type A and Type B AEs, and how to assess the severity and probability of an adverse drug reaction (ADR). This unit also covers Individual Case Safety Reports (ICSRs) in detail, including their structure, content, and role in trial monitoring. Other topics include types of PV inspections, periodic safety update reports (PSURs), and study criteria for instituting data safety management boards (DSMBs).

In this chapter, we provide a detailed review of the protocol for receiving, storing and dispensing the investigational product (IP). At every stage, there are guidelines in place to ensure the safety of study subjects and staff. This includes handling the IP with care, logging relevant information such as date of manufacture and batch number, and recording shipping details. Additionally, we address the need for precautions when dispensing the IP, such as limiting access to authorized personnel only.

This section looks at how lab testing in clinical trials has changed over time. It used to be done in local labs, which had a lot of mistakes. Now it is done in central labs, which makes it more accurate and reliable. The section also covers standards for clinical trial laboratories, such as the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments). Additionally, it provides guidelines for lab audits, including fire safety and staff training.

The chapter reviews essential documentation that needs to be created and maintained throughout the clinical trials. This includes the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312. You will learn about each of these forms and why it is important to keep records updated, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. The unit also requires that you submit documents that describe the procedures for the study and site, including an SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR). This includes Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56), Series on food (100), pharmaceuticals (200 and 300), as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES). Part 11 lays down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

This module will cover the process of how drugs are evaluated by the FDA, and the role of a CRA in this process. You will learn about the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The criteria for evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, you will learn about FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators.

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF.

In this chapter, we will discuss FDA guidelines regulating financial disclosure in depth. This will cover the definition of 'conflict of interest' and the stipulations of Title 21 Section 54 on disclosure requirements. We will also study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on 'fair market value' as well.

The chapter also talks about things that might make it hard to meet recruitment goals, and how to make it easier, like being less picky about who can join, giving people money to cover travel costs, and making it clear what benefits come from participating. The unit also covers why patients might leave a trial early, and how to prevent that from happening as much, like making the experience better for patients (by paying more attention to them and being flexible with when they can come in for visits, etc.), and using technology to make things simpler and more efficient (like having digital forms that can be completed automatically). Finally, the unit discusses some new ways of keeping patients involved and compliant in clinical trials; these techniques use technology to get better results.

This module discusses reasons why people might commit scientific fraud, and the consequences of fraudulent practices in clinical trials. A scale is presented for classifying errors in clinical trial data. At one end of the spectrum is ‘honest, isolated mistake’ and at the other end is ‘deliberate data falsification with malicious intent’. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will learn how to identify signs of fraud during the actual clinical trials process.

Clinical Research Associate: Roles & Responsibilities

Introduction

Clinical research plays a pivotal role in advancing medical knowledge and patient care. At the heart of this process are Clinical Research Associates (CRAs), professionals who ensure the efficacy and safety of clinical trials. As the pharmaceutical and biotechnology industries expand, so does the demand for skilled CRAs. This blog aims to demystify the roles and responsibilities of a CRA and highlight the significance of this career in the realm of clinical research.

A Clinical Research Associate is a professional who monitors the administration and progress of a clinical trial (a research study that tests how well new medical approaches work in people). Typically, CRAs hold a degree in pharmacy, life sciences, nursing, or a related field, combined with substantial knowledge of clinical research protocols. They are the linchpins in the development of drugs, biologics, and medical devices, bridging the gap between the clinical trial process and regulatory compliance.

Key Responsibilities of a Clinical Research Associate

1. site selection and preparation.

CRAs are involved in selecting suitable sites for clinical trials, and assessing the capabilities of a site to conduct the trial. This involves evaluating the staff’s qualifications, the facility’s equipment, and the site’s patient population. They also play a key role in preparing the site for the study, ensuring that each site has the necessary materials and training to conduct the trial according to protocol.

2. Protocol Development and Implementation

CRAs contribute to developing the clinical trial protocol, a document that outlines the objectives, design, methodology, statistical considerations, and organization of a trial. They ensure that the trial is implemented as per the protocol and that any deviations are documented and justified.

3. Subject Recruitment and Consent

A crucial aspect of a CRA’s role is facilitating the recruitment of subjects for the trial. They ensure that potential subjects are properly informed about the trial and that informed consent is obtained in accordance with regulatory requirements.

4. Monitoring Clinical Trials

CRAs regularly visit trial sites to monitor the progress of the trial. They verify that the clinical trial data recorded by investigators is accurate and that the trial is being conducted in compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements.

5. Ensuring Compliance

CRAs ensure that clinical trials comply with regulatory standards and ethical guidelines. They are responsible for understanding and keeping up to date with regulations and guidelines, such as those set by the FDA or EMA.

6. Data Management and Reporting

Managing and overseeing the data collected during clinical trials is another key responsibility. CRAs review data for accuracy and completeness and assist in preparing reports on the trial’s findings.

Challenges Faced by Clinical Research Associates

CRAs often face challenges such as managing responsibilities across multiple trial sites, ensuring data integrity, and adapting to constantly changing regulatory environments. Problem-solving skills, adaptability, and a keen eye for detail are essential traits for success in this role.

The Future of Clinical Research Associates

The role of a CRA is evolving with advancements in technology and changes in the regulatory landscape. CRAs are increasingly involved in virtual or remote monitoring of trials, using digital tools to manage and oversee trial progress. As the field grows, so do the career paths and advancement opportunities for CRAs.

Clinical Research Associates play a critical role in the success of clinical trials. They ensure that trials are conducted ethically, efficiently, and in compliance with regulatory standards. The role of a CRA is not only challenging and demanding but also highly rewarding, contributing significantly to the advancement of medical research and patient care.

Related Posts

Welcome to ClinicalResearchInfo.com: Empowering Your Journey in Clinical Research

Navigating the Basics of Clinical Trials: A Beginner’s Guide

6 skills to be a successful Clinical Research Associate: #SuccessFactors

Share This Job

On the hunt for a fulfilling career as a clinical research associate here are six essential skills to consider for a successful career path as a cra at iqvia..

At IQVIA, we are tackling some of the biggest challenges in healthcare in pursuit of our mission to accelerate innovation for a healthier world. Our clinical research associates (CRAs) play a vital role in that effort, serving as overseers, conductors and documenters of our clients' clinical trials. 

CRAs at IQVIA are ambitious, passionate and bring a deep level of expertise to solve complex clinical issues while ensuring adherence to regulations and sponsor requirements. An IQVIA CRA’s ultimate goal is to deliver life-changing therapies as fast as possible, but without compromise.

Think this might be the career for you? Here are the top 6 factors to support a successful career as a CRA at IQVIA.

• 1. Communication

As a CRA, you are the key liaison between management, the study site, and the sponsor. With so many moving parts in clinical research, strong interpersonal skills and good command of English are important. It is also critical to have fluency in the local language of the respective country you work in. When difficult conversations come up, you’ll rely on these skills to effectively manage the situation and ask thoughtful questions. 

“Effective communication as a CRA comes down to considering your audience and their unique needs,” said Clinical Functional Service Provider CRA. “As a CRA, you regularly have conversations with healthcare professionals, management and site personnel, all with varying education levels, knowledge and skillsets. It’s important to read the room, know how your audience wants to receive information and pivot based on who you’re talking to.”

2. Relationship management 

A CRA builds relationships with all parties involved in the trial. Much like communication, there are nuances to these relationships. A great CRA knows when to lead versus support, can effectively manage through site-related issues and stays connected to study staff and research sites. 

“Relationship management is a pivotal component of monitoring,” said Senior CRA. “Establishing trust between yourself, as the CRA, and the sponsor and site staff help create a positive work environment for all parties. These relationships are beneficial to study compliance, productivity and collaboration so we can all achieve our end goal to improve patient outcomes.”

3. Attention to detail 

Keen attention to detail while executing site activities — initiation and start-up, recruitment, monitoring, site management and close-out — is critical to the quality and integrity of any study as the smallest error can lead to major consequences. As a CRA, your meticulousness in documenting how you conduct protocols, adhere to applicable regulations and capture site findings and action plans is foundational to the study’s success. 

“Find a tool that works best for you… it can be anything from old fashioned pen and paper, folders, spreadsheets or digital notes…whatever you choose, just be sure to capture everything you and the site have done and still need to do,” said Janet Robinson, senior CRA 3. “We work in an environment where everything is important, and if it’s not documented, it didn’t happen. An acute eye for detail will ensure that you keep accurate and timely notes at every stage. This will help later with time management, too!”

4. Critical thinking

Rapidly changing protocols, low patient recruitment and data errors are the norm in clinical research. As a CRA, you are the decision-maker, and the site team relies on your clinical expertise when it comes to spotting and solving problems. Critical thinking is key. If you spot a site-related issue or error that could impact data or patient safety, chart a course for corrective action. Study protocols, Good Clinical Practice (GCP) documents and operating procedures are all tools to support you in mitigating risk that could jeopardize the integrity of a study or cost the sponsor time and money. 

“Rather than letting adversity get you flustered, reflect on past experiences and use a ‘no time wasted’ approach to influence the outcome of a future project or milestone,” said Clinical Functional Service Provider CRA 2. “Take a step back to evaluate the situation, use your resources, training and past experiences to brainstorm potential solutions, and deliver quickly and compliantly.”

5. Time management

As a CRA, no two days are the same, and you must adapt to an ever-changing environment. A well-trained CRA must be able to effectively prioritize their time and juggle competing priorities across projects and site personnel to ensure the trial is carried out within the appropriate deadlines and within budget. 

As for managing your day-to-day responsibilities, sometimes figuring out where to begin is the biggest problem. Your task list can feel overwhelming, so a simple to do list is a great way to arrange your responsibilities. Rank your tasks by priority and tackle them one by one!

6. Stress management

Being a CRA is not always glamorous. There are long days on the road, rapidly changing protocols and monitoring reports to complete across multiple study sites. Treating patients with drugs for the first time can be stressful for patients and CRAs alike. 

“As a junior CRA, you have done the training, but now it’s time to pull all the pieces together, and that can be a daunting and overwhelming thought,” said Robinson. “Finding a mentor to field questions without judgement can help alleviate some of the stress. At IQVIA, we have a fantastic mentor program to help our CRAs navigate those early days and thrive through their career.” 

Off the job, find your outlet, whether that’s mediation, exercise, reading or spending time with family and friends. IQVIA is a huge proponent of work-life balance. We know you can’t be successful at your day job if you are not taking care of your mental, physical and social health, and we are here to support you to that end. 

What can you expect in return from IQVIA?

Love what you’ve read and think you’re a great fit for a CRA role?   Join us ! IQVIA offers a rewarding career path, compensation structure and development programs for CRAs. Our well-established training programs, access to cutting-edge technologies and the stability of a global organization enables you to have a long-lasting and fulfilling career journey as a CRA at IQVIA. 

“At IQVIA, we are committed to supplying our CRAs with the right tools, training and development support to allow for success and career growth,” said Dan Mink, director, Clinical Operations. “In addition to the rewarding work, collaboration and engaged line management, there is a constant focus on development as your career growth supports also the growth of the company.” 

Take the first step toward a fulfilling CRA career at IQVIA.  Apply to our CRA jobs today.

Explore life at IQVIA

Join our Global Talent Network

Let’s stay connected.

Join our network

Clinical Research Associate I (Trial Monitor) - Remote

🔍 minneapolis, minnesota, united states.

POSITION SUMMARY:

 Please apply online using a laptop or desktop computer.

This position supports the CIBMTR CRO Services team by supporting the management of one or more multi-center clinical research studies. This position performs site monitoring visits to complete source document verification and assess site compliance. Additionally, this position is responsible for coordinating and providing support for all aspects of the study including protocol and site management.   This position can be remote (US) or hybrid.  #LI-Remote #LI-Hybrid 

Check out our video Saving Lives: It’s the Best Job Ever

ACCOUNTABILITIES:  

Monitoring:

• Perform full-scope remote and on-site monitoring visits involving source document verification, review of essential regulatory documents, and assessing site performance. 
• Ensure compliance with clinical trial protocols based on regulations, ICH GCP guidelines, and NMDP standard operations procedures.
• Identify and communicate site findings with site study personnel and the study team.
• Perform query management activities and generate study and site status reports.
• With oversight and guidance, analyze trends in identified issues and author visit reports and letters. Ensures documentation and resolution of identified issues and implementation of corrective and preventative action. 

Site Management:

• Oversee and manage operational aspects of clinical trial sites in conjunction with project teams.
• Assists with site activation and ensures study start-up and enrollment goals are met.
• Collect and review essential documents for investigational sites, including maintenance of electronic Trial Master File.
• Serves as primary liaison for site management issues for assigned studies, escalating to the clinical project manager as required. 
• Utilizes effective and proactive communication, relationship building, and issue management to develop and maintain good working relationships with Investigators and site staff.
• Provide support to Investigators, Study Coordinators, and other appropriate site personnel regarding study workflow, overcoming obstacles and general questions regarding study conduct.

Centralized Monitoring:

• Assists in reviewing study site data and data reports to ensure timely and accurate submission and compliance with the study protocol.

Other duties as required for clinical operations:

• Performs all duties in compliance with standard operating procedures, regulations outlined in the Code of Federal Regulations (CFR), ICH GCP guidelines, Federal Drug Administration (FDA) guidance and other applicable Federal, state, and local laws. 
• Assist in user acceptance testing (UAT) of clinical database management system for individual clinical trials.
• Performs study tracking (e.g., CTMS, start-up, milestone, closeout); generates, reviews, and distributes management reports from internal tracking systems at requested intervals.
• Develops, maintains, and presents, in conjunction with senior staff, clinical trial and project specific training materials.  
• Assists study related problem-solving activities internally and at trial sites.
• Assists in protocol maintenance, tracking, and communications.
• Works with internal and external team members to deliver high quality trial execution.
• Participates in shared team responsibilities, ensuring optimal coverage of trials.
• Participates in NMDP, CIBMTR, or CIBMTR CRO Services project teams as needed.
• Complete and maintain all training requirements.
• Develop, maintain, and continuously improve study and site management processes, guidelines, tools, templates, best practices, and overall implementation.
• Other duties as assigned.

REQUIRED QUALIFICATIONS:

Knowledge of:

• Clinical research study processes, study design, and protocol management.
• Medical terminology and anatomy/physiology.
• Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of internet.
• Training and conflict resolution skills.
• Time management skills and problem-solving abilities.

Ability to:

• Demonstrate excellent oral and written communication.
• Manage multiple deadlines and priorities while ensuring quality and timeliness.
• Perform tasks requiring excellent attention to detail. 
• Demonstrate independent problem-solving and decision-making for straightforward situations but requires guidance for complex situations.
• Analyze trends, identify issues, and escalate as appropriate.
• Adapt to change.
• Navigate processes and people involved in clinical research, demonstrating organizational awareness and interpersonal skills necessary to complete work efficiently.
• Perform onsite visits. Expect to travel 50 - 70% of time (domestic and international) to sites, as necessary.
• Must exemplify our NMDP values in a highly professional manner in all settings.

Education and/or Experience:

• Bachelor’s degree in healthcare/science related field; however, upon evaluation, equivalent related experience and/or education may be substituted for the scientific or health-related degree requirement. 
• Minimum three years’ experience of conducting clinical research studies according to ICH GCP guidelines and/or verifying clinical data from medical records.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications.
• Direct experience working at research sites on clinical studies, with or without direct interaction with patients.
• ACRP or SOCRA certification.

DEI COMMITMENT: 

As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.

 BENEFITS: NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave, and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information

• Number of Openings: 1
• Pay Basis: Yearly
• Schedule: Full-time
• Driver Policy: No
• Job Family: Research & Development
• Career Category: Professional
• Career Level: 5

Previous Job Searches

Create and manage profiles for future opportunities.

My Submissions

Track your opportunities.

National Marrow Donor Program - Entrusted and under contract to operate the C.W. Bill Young Cell Transplantation Program, including NMDP Registry℠.

Copyright © 2024 National Marrow Donor Program. All Rights Reserved.

• Privacy Policy
• Terms of Use
• Trademark and Copyright

Clinical Research Coordinator Associate

🔍 school of medicine, stanford, california, united states.

The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University’s School of Medicine, is a world-leading department that offers comprehensive training and perioperative patient care, pain management, and critical care medicine as well as cutting-edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education.

The Department of Anesthesiology, Perioperative, and Pain Medicine at Stanford University is seeking a Clinical Research Coordinator Associate. The Clinical Research Coordinator will perform duties related to helping establish and coordinating moderately complex aspects of one or more clinical studies. The Clinical Research Coordinator will join a vibrant and innovative team committed to pediatric sleep, pain, and opioid research under P.I., Dr. Cornelius Groenewald. This lab includes multiple NIH funded research projects that collectively aim to address the impact of the opioid epidemic on children and adolescents, through identifying factors that contribute to development of opioid misuse. Lab projects involve questionnaire, physiological (actigraphy) and opioid use data collection (electronic medication adherence technology). The Clinical Research Coordinator will work under close direction of the principal investigator and research supervisor/manager.

At Stanford University School of Medicine, the work we do touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health.

Stanford is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends, and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.

The School of Medicine and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department.

For more information on our department, please see our website: https://med.stanford.edu/anesthesia.html

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies.   Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.   Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.   Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.   Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.
• Interact with lab members and collaborators to assist with other studies and tasks as needed.
• - Other duties may also be assigned

DESIRED QUALIFICATIONS:  

• Knowledge of principals of clinical research and federal regulations.
• Ability to effectively work in a fast paced environment with multiple projects and timelines.
• Familiarity with IRB guidelines and regulations.
• Previous experience with REDcap and other related database applications.
• Previous experience working with children and families.

EDUCATION & EXPERIENCE (REQUIRED):

Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

Occasional evening and weekend hours.

WORK STANDARDS

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,  http://adminguide.stanford.edu

The expected pay range for this position is $31.73 to $36.54 per hour. 

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. 

This position is located at Stanford Research Park (Porter and Page Mill Road), and the Center for Academic Medicine at Lucille Packard Children’s Hospital (Quarry Rd, Palo Alto CA). Option for hybrid work may be offered.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Regular
• Requisition ID: 103097
• Work Arrangement : Hybrid Eligible

My Submissions

Track your opportunities.

Similar Listings

 School of Medicine, Stanford, California, United States

📁 Research

Post Date: Jan 29, 2024

Post Date: Feb 15, 2023

Post Date: Aug 05, 2022

Global Impact We believe in having a global impact

Climate and sustainability.

Stanford's deep commitment to sustainability practices has earned us a Platinum rating and inspired a new school aimed at tackling climate change.

Medical Innovations

Stanford's Innovative Medicines Accelerator is currently focused entirely on helping faculty generate and test new medicines that can slow the spread of COVID-19.

From Google and PayPal to Netflix and Snapchat, Stanford has housed some of the most celebrated innovations in Silicon Valley.

Advancing Education

Through rigorous research, model training programs and partnerships with educators worldwide, Stanford is pursuing equitable, accessible and effective learning for all.

Working Here We believe you matter as much as the work

I love that Stanford is supportive of learning, and as an education institution, that pursuit of knowledge extends to staff members through professional development, wellness, financial planning and staff affinity groups.

School of Engineering

I get to apply my real-world experiences in a setting that welcomes diversity in thinking and offers support in applying new methods. In my short time at Stanford, I've been able to streamline processes that provide better and faster information to our students.

Phillip Cheng

Office of the Vice Provost for Student Affairs

Besides its contributions to science, health, and medicine, Stanford is also the home of pioneers across disciplines. Joining Stanford has been a great way to contribute to our society by supporting emerging leaders.

Denisha Clark

School of Medicine

I like working in a place where ideas matter. Working at Stanford means being part of a vibrant, international culture in addition to getting to do meaningful work.

Office of the President and Provost

Getting Started We believe that you can love your job

Join Stanford in shaping a better tomorrow for your community, humanity and the planet we call home.

• 4.2 Review Ratings
• 81% Recommend to a Friend

View All Jobs

Office of Science Policy

Home » FDA-NIH Want Your Input on a New Resource for Terminology in Clinical Research

FDA-NIH Want Your Input on a New Resource for Terminology in Clinical Research

Consider the tomato. Or as some would call it, the “tomahto.” The whole tomato-tomahto debate has entered the language as an example of a difference so small, it doesn’t change anything.  For example, people will generally know what you are referring to no matter how you pronounce it.  But what if one group of people thought a tomato was a red plant suitable for making delicious curries and burger toppings, while other thought a tomahto was a green fruit only found in the southern Australia?  This misunderstanding would certainly cause some considerable confusion at the family barbeque.

I choose the example above since it provides a good analogy for a problem that NIH and FDA have identified in the clinical research space: critical terms are not being used consistently across the clinical research landscape.  This is specifically problematic when discussing innovative clinical trial designs and certain studies using real world data to generate real world evidence. What are some of the perils of having a modern-day Tower of Babel when it comes to clinical research? For starters, if different words mean different things to people, and are operationalized differently in different trials, how can we compare results from or pool data from different trials?   Inconsistent usage of terms can also pose specific challenges in understanding the intended meaning and impact of terms.  Problems from inconsistently terms can also cause major headaches when trying to describe a study design, communicating the goals of a planned study, or interpreting and describing research results.

To avoid the pitfalls that inconsistent use of terms can lead to, NIH and FDA created an inter-agency team of experts to study the issue and develop a resource that could be used to assist the research community in effectively communicating about clinical trials.  As a result of the team’s efforts, NIH and FDA have released a glossary of terms related to clinical research for public comment.  Right off the bat, we should make clear that this glossary is not intended to cover the entire landscape of clinical research.  The glossary contains 37 terms the team identified as being inconsistently used within the scientific community. 

The NIH and FDA are most interested in hearing community feedback on the utility of the glossary in its goal of promoting effective communications.  In addition, we want to hear from you about how we did.  Did we leave any words out that we should have included? Did we include any words that aren’t necessary?  Comments on the draft glossary will be accepted until June 24, 2024.  For more information, including how to view the glossary and how to provide comments, please visit: https://osp.od.nih.gov/comment-form-fda-nih-resource-on-terminology-for-clinical-research/

The NIH and the FDA encourage all interested parties to review the glossary and provide feedback to ensure the glossary meets its directed effect. Having a resource that defines these often inconsistently used terms will help ensure that valuable clinical research is not lost in translation.

Lyric Jorgenson, PhD

Subscribe to our blog.

If you would like to stay up to date with the Office of Science Policy, subscribe to our blog!

Looking for more content? Check out our social media!

• NIH Director’s Blog
• NCI: Bottom Line
• NCATS: Director’s Corner
• NIAMS: Letters from the Director
• NIDA: Nora’s Blog
• NIGMS: Feedback Loop
• NINDS: Director’s Messages
• NLM: Musings from the Mezzanine
• NIA: Inside NIA

Share on Social Media

Leave a reply.

Your email address will not be published. Required fields are marked *

• Insights & Events

About McDermott

• Firm Overview
• Vision & Values
• Our Approach
• Justice, Diversity, Equity & Inclusion
• Pro Bono & Community Service

FDA Establishes CDER Center for Clinical Trial Innovation (C3TI)

• FDA Establishes CDER Center for Clinical Trial Innovation (C...

On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support hub for innovative approaches to clinical trials designed to improve the quality and efficiency of drug development and regulatory decision-making.

As the division of FDA responsible for regulating drugs and certain biologics, CDER’s authority includes overseeing the development and testing of such products. As technology advancements and challenges and opportunities in drug development evolve, CDER is seeking to cultivate drug development and innovation through novel clinical trial designs, trial execution strategies and drug development tools and by leading or co-leading several efforts to foster improvements across the study design landscape. One such effort included a public solicitation of comments on the barriers of clinical trial designs on October 17, 2023. After discussion of the comments, FDA determined that the establishment of C3TI would enhance CDER’s ability to address those barriers and foster innovation.

C3TI is governed by various offices of CDER, including the Office of the Center Director, the Office of Communications, the Office of Compliance, the Office of Medical Policy, the Office of New Drugs and the Office of Translational Sciences. C3TI’s mission is to “promote existing and future CDER clinical trial innovation through enhanced communication and collaboration.” C3TI aims to improve clinical trial efficiency, effectiveness, data quality, innovation and coordination in the hope that such efforts will increase the participation of diverse populations in clinical trials and accelerate the development of safe and effective drugs.

• Facilitate the sharing of lessons learned across CDER’s existing clinical trial innovation programs
• Communicate and collaborate with external parties regarding innovative clinical trials
• Manage a C3TI Demonstration Program to expand opportunities for sponsors to interact with CDER staff

The C3TI Demonstration Program will initially consist of three project areas under a pre-investigational new drug application (pre-IND) or IND: (1) point-of-care or pragmatic trials, (2) Bayesian analyses and (3) trials using selective safety data collection. Sponsors may submit program proposals via email to [email protected] . The program will accept up to nine proposals on a rolling basis within a 12-month period. Sponsors selected for the program will engage with CDER staff to serve as case examples and generate lessons for the broader community.

C3TI is under development and will eventually serve as the conduit for internal and external parties to access resources and obtain information regarding clinical trial designs and innovation efforts. Stakeholders including sponsors, contract research organizations and other service providers in the research industry, and entities conducting industry-sponsored research should monitor C3TI’s development and implementation. The learnings that emerge from C3TI’s activities may meaningfully shape clinical trial strategy and related business offerings in the research industry.

For more information on C3TI, visit the C3TI webpage or contact one of the authors or any other member of McDermott’s Food, Drug & Medical Device Regulatory Practice Group . McDermott will continue to monitor C3TI’s activities as FDA continues to develop the repository.

Jae Hyun Lee, law clerk in McDermott’s New York office, also contributed to this article.

Stay Connected

James r. ravitz.

Partner | Washington, DC

Paul S. Gadiock

Partner | San Francisco

Jiayan Chen

Marissa hill daley.

Associate | Washington, DC

Nathan Gray

Karis jackson.

ACRP 2024 is where clinical researchers GO for inspiration, education, and connection. Join us from May 3 – 6 in Anaheim, CA!

Clinical Trials Day

The only global awareness campaign dedicated to recognizing and championing clinical research professionals.

CELEBRATE WITH US!

ACRP Ride4DEI

This fundraiser supports clinical researchers from diverse backgrounds by providing life-changing educational grants and tuition scholarships.

GET INVOLVED

ACRP Budget Buddy™

Budgeting for DCTs at your site just got a whole lot easier. Visit the new DCT Resource Center to get the new ACRP DCT Budget Buddy™.

Advancing People Advancing Health™

ACRP is moving the people and practice of clinical research forward™.

The Call for Proposals for ACRP 2025 is Open Through June 17.

Become a Member

Connect with the resources and people you need for career success.

Get Certified

Apply now to take your exam from home, on-demand, 24/7.

Get Started

Changing Perspectives on Clinical Research Through Mindfulness and Professionalism

Blog May 6, 2024

On Day Two of ACRP 2024 in Anaheim, Calif., attendees were invited to take advantage of “the power of pause” to calm down their overstressed and nonstop brains, while […]

Workforce and Patient Engagement Issues Capture Attention at ACRP 2024

Blog May 5, 2024

Activating more clinical trials that will successfully deliver new and improved drugs and medical devices to the public demands a modern clinical research workforce whose employers and other stakeholders can […]

Quest for Better Clinical Research Early Talent Hiring Practices a ‘Race That Never Ends’

Stakeholders in the matter can best leverage cutting-edge options for overcoming the inadequacies of current early talent hiring practices in the clinical research industry if they approach the challenge with […]

Front Range Chapter: Team Science Competencies for Clinical Research Professionals: A Leveled Approach (ACRP 2023 Replay)

May 13 @ 5:00 pm

Join the Front Range Chapter for a virtual event discussing team science competencies. This presentation is a webinar replay from the ACRP 2023 conference.

Fall 2024 Initial Certification Early Bird Registration

Earn your ACRP certification at reduced rates by registering during the Fall 2024 Early Bird window, May 15 – July 15, 2024. ACRP members save even more!

NY Metro Chapter: Movie Night: Of Medicine and Miracles

May 20 @ 6:30 pm

Join the NY Metro Chapter for a virtual event based on the movie Of Medicine and Miracles.

View All Events

The New Frontier: How Smartphone Data Can Revolutionize Cancer Care

• Share to Facebook
• Share to Twitter
• Share to Linkedin

By Jacob Ellen

The potential of patient-generated data in glioblastoma (GBM) research represents a paradigm shift in how we approach the study and treatment of the most aggressive and deadly form of brain cancer.

Progress in GBM research and treatment has been painfully slow. Median life expectancy at diagnosis is a devastating 12 to 16 months, with only 5% of patients surviving beyond five years. Traditional methods of monitoring the progression of the disease, such as imaging and clinical exams, are conducted infrequently at follow-up appointments in the clinic. Meanwhile, self-reported patient questionnaires offer only a snapshot in time, and can be compromised as the person experiences gradual cognitive decline.

There is another way.

Patient-generated “passive data,” collected from smartphones, offers an alternative – continuous, real-time insights into the health and behavior of those living with GBM that can be aggregated to create a more comprehensive assessment of a patient’s disease progression.

Passive data is the information that you and I generate through our smartphones often without realizing it. Its beauty lies in the fact that it is produced by definition without a patient’s active participation.

Yet it can encompass a wide range of information about the person, such as their physical activity levels, sleep patterns, and geographical data like daily distance traveled and screen time data. This kind of data is ubiquitous, but often overlooked. It can provide insight into the daily lives and health statuses of individuals.

And this data is especially important in the context of GBM, a disease that forces changes in cognitive function and physical mobility that are progressive, although often subtle at first.

One of the primary benefits of passive data collection is its ability to provide a comprehensive picture of a patient's cognitive and physical health without requiring active self-reporting, which can be burdensome for patients. For example, alterations in physical activity patterns or daily routines, as detected through GPS data, could signal a decline in physical health or the onset of new symptoms.

Similarly, a decline in the speed and accuracy of responding to texts or changes in the complexity of language used in digital communication could indicate an alteration in cognitive function. Indeed, the ability to continuously monitor these aspects can lead to a deeper understanding of the impacts of GBM and different treatment regimens on daily quality-of-life for patients.

This is a new frontier that could be particularly useful in certain patient populations, including those who may not be able to make it to the hospital for regular follow-up visits, who do not speak English and/or who struggle with technology and may not find an online quality-of-life survey easy to complete.

A new collaboration between OurBrainBank, a non-profit founded by GBM patients and their families, Harvard scientists and neurosurgeons, and neuro-oncologists at the Dana-Farber Cancer Institute, is moving towards harnessing this type of passive data for GBM patients. OurBrainBank is the only patient and caregiver-led GBM non-profit that focuses on patient-led research and data collection .

The project in development has a few main goals:

The first is to use smartphone data to improve the clinical management of gbm..

By providing a continuous stream of real-time data, healthcare providers can gain insights into the effectiveness of treatments and their side effects, hopefully leading to more personalized and adaptive treatment plans that consider the evolving nature of the disease and the unique response of each patient.

More specifically, our collaboration will investigate whether we can use these individual patterns to detect tumor recurrence earlier, possibly even before it shows up on a scan. This could lead to earlier treatments and ultimately better patient outcomes.

The second goal is to investigate quality-of-life in GBM patients with a focus on loneliness and social isolation as the disease progresses.

Social isolation is a major difficulty for GBM patients and can occur due to diminished social support, reduced energy and time for socializing due to treatment demands, and the stigma associated with GBM.

We aim to use passive data to better characterize the social isolation of GBM patients over the entire disease course, with the ultimate goal of increasing support mechanisms and targeted interventions to enhance the quality-of-life of GBM patients. We also hope to learn more about the quality-of-life of GBM caregivers, a group that is too often ignored in studies to date.

This multidisciplinary initiative to harness passive data for GBM research could represent a significant leap forward in the fight against this challenging disease, and complex diseases more generally. By embracing the capabilities of modern smartphones and the wealth of data they generate, researchers, clinicians, and patients can work together more effectively to improve outcomes.

This approach not only empowers patients by making them participants in their own care, but also paves the way for more responsive, personalized, and effective treatment.

Jacob Ellen is a Harvard medical student and a member of the US board of OurBrainBank, an international non-profit that is advocating on behalf of GBM patients and families in both the US and the UK. Please contact us at [email protected] if you would like to help or donate, visit our website www.ourbrainbank.org for more information.

This is a content marketing post from a Forbes EQ participant. Forbes brand contributors’ opinions are their own.

• Editorial Standards
• Reprints & Permissions

NIH VideoCasting

CIT can broadcast your seminar, conference or meeting live to a world-wide audience over the Internet as a real-time streaming video. The event can be recorded and made available for viewers to watch at their convenience as an on-demand video or a downloadable file. CIT can also broadcast NIH-only or HHS-only content.

VideoCast Send Live Feedback

CCR Grand Rounds: Lentiviral Gene Therapy for Blood Disorders: Wiskott-Aldrich Syndrome