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Hematologist/Oncologist

Hematologist/Oncologist

Stroudsburg, Monroe, Pennsylvania • Excellent Compensation Package

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9 Tips for Finding and Landing an Oncology Job

The end of your fellowship is in sight, and it's time to start looking for your first oncology job. Below are tips, along with links to  ASCO Connection articles and blogs, that will help you prepare for your interview and—hopefully—land a job.

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Physician Wellness and Professional Burnout

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Clinical Research Jobs at Dana-Farber Cancer Institute

Found 37 clinical research jobs, assistant clinical research manager - pediatric oncology experimental therapeutics.

This position will work within the clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. These positions, in collaboration with the program’s Clinical research Managers physicians and research nursing …

Associate Director, Clinical Research Program

The Associate Director, Clinical Research Program will oversee all clinical trials and translational research operations, regulatory and compliance within the Multiple Myeloma Disease Program. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united …

Associate Director, Clinical Trials Operation

Reporting to the Senior Director, Clinical Trials Office, the Associate Director, Clinical Trials Operations is responsible for the overall management and oversight of the assigned Clinical Research Disease group managers. The Associate Director oversees all clinical trial operations activities, has direct supervisory responsibilities for the Clinical Research Managers, and indirect …

Clinical Research Coordinator

The Center for Early Detection and Interception of Blood Cancers seeks a Clinical Research Coordinator to assist in the day-to-day management of non-interventional trials. This position works within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the …

Clinical Research Coordinator - Bone Marrow Transplant

The Clinical Research Coordinator work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical information as …

Clinical Research Coordinator - Breast Oncology Cohort Studies Program

The Clinical Research Coordinator will support the Breast Oncology Cohort Studies Program and its clinical and translational research in the areas of screening, recruitment, data collection, assurance of high-quality data, biospecimen collection and database organization. Duties include the examination, synthesis, and evaluation of medical records for screening and tracking of …

Clinical Research Coordinator - Center for Cancer Therapeutic Innovation

Clinical research coordinator - genitourinary oncology, clinical research coordinator - gi oncology.

The Gastrointestinal (GI) Oncology Clinical Research Program at Dana-Farber Cancer Institute is seeking a Clinical Reserach Coordinator to join our program. The GI Oncology Clinical Research Program supports PI initiated, industry sponsored, and cooperative group phase I - IV clinical trials across multiple GI cancers, including esophageal, stomach, liver, pancreas, …

Clinical Research Coordinator - GYN Tumor Banking & Minimal Risk

The Clinical Research Coordinator will work within the clinical research program and support the research team in the overall conduct of Gynecologic Oncology tumor banking and minimal risk clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI Clinical Trials Office. The CRC will …

Clinical Research Coordinator - Gynecologic Oncology

The Clinical Research Coordinator work within the GYN Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical …

Clinical Research Coordinator - Head & Neck Oncology

The Clinical Research Coordinator work within the Center for Head and Neck Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and …

Clinical Research Coordinator - Leukemia

Clinical research coordinator - multiple myeloma, clinical research coordinator - neuro oncology.

The Clinical Research Coordinator work within the Neuro Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical …

Clinical Research Coordinator - Pediatric Oncology/Solid Tumor Program

The Pediatric Solid Tumor Program at Dana-Farber Cancer Institute is seeking to hire a motivated Clinical Research Coordinator (CRC) to work within the Clinical Translational Research Program (CTIP) on trials specific to the Solid Tumor Clinical research portfolio. The pediatric Solid Tumor Program is one of the largest in the …

Clinical Research Coordinator - Pediatric Solid Tumor Biology

The Pediatric Solid Tumor Program at Dana-Farber Cancer Institute is seeking to hire a motivated Clinical Research Coordinator (CRC) to work within the Clinical Translational Research Program (CTIP) on trials specific to the Solid Tumor Biology and research portfolio. The pediatric Solid Tumor Program is one of the largest in …

Clinical Research Coordinator - Regional Campus (Based in Londonderry, NH)

Clinical research coordinator - thoracic oncology.

The Clinical Research Coordinator work within the Thoracic clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical information …

Clinical Research Coordinator II - Lymphoma

The Clinical Research Coordinator work within the Lymphoma clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical information …

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Research data specialist - gi oncology.

Parexel

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Clinical Research Associate (CRA II/Senior CRA - Oncology/Ophthalmology)

Parexel Glassdoor Reviews

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

  • Communicator
  • Detail-oriented
  • Problem-solver
  • Self-starter

About This Role

Working with heart

At the end of the day we’re all patients. Because of this, the Parexel team takes our work personally and does it with empathy and heart. When our values align, there’s no limit to what we can achieve. Our clinical operating model drives effectiveness, reduces handoffs and increases employee, client and site satisfaction. As a Clinical Research Associate at Parexel, you will be joining a team with a wide variety of experiences and knowledge. We hire talent that takes initiative to do things better, smarter and faster- people who want to grow personally and professionally.

Your time here

At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor.  CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they are set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You will also manage site quality and delivery from site identification through to close-out. As a CRA, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel may be your next home.

What you’ll do 

  • Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
  • Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
  • Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.
  • Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines while also Ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
  • Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.
  • Execute. Monitor completeness and quality of Regulatory Documentation and perform site document verification.

A little about us

Parexel is proud to be a leading Clinical Research Organization with team members across the globe. As a member of our team, you will get to know your colleagues on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or colleague are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.

More about you

On your first day we’ll expect you to have:

  • 18+ months Clinical Research Associate (CRA) monitoring experience in clinical research with understanding of clinical trials methodology and terminology.
  • Bachelors or equivalent degree in biological science, pharmacy or other health related discipline.
  • Strong interpersonal, written, and verbal communication skills within a matrixed team.
  • Ability to work in a self-driven capacity with a sense of urgency and limited need for oversight.
  • A client focused approach to work with a flexible attitude with respect to assignments and new learning.
  • The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
  • An honest and ethical work approach to promote the development of life changing treatments for patients.
  • Oncology/ophthalmology experience preferred.
  • Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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Potential Career Path

Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.

  • Project Management Subject Matter Expert People Management

Employee Insights

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Nick on a day in the life of a CRA

Nick Burger | Clinical Research Associate II

Watch Video

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Liliana on CRA tasks and our recognition program

Liliana Belmares Flores | Senior Clinical Research Associate

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Marlayna on why Parexel is a great place for CRAs

Marlayna Fitts | APEX CRA Field Coach

TEAM IMPRESSIONS

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Why Clinical Research Associates work at Parexel

clinical research associate oncology jobs

Patient-focused in everything we do

We push the boundaries of what is possible to create clinical trials that are inclusive, innovative, and patient-focused

clinical research associate oncology jobs

Supportive and inclusive environment

We foster collaboration, teamwork, respect, and inclusivity, to work together to achieve common goals.

clinical research associate oncology jobs

Career growth and development

We develop your skills through training, mentorship, and career advancement programs.

clinical research associate oncology jobs

Flexible work arrangements

We focus on outputs and results, not where and when you work.

clinical research associate oncology jobs

Diverse therapeutic areas and project exposure

We continuously learn from a broad exposure from early to late phase clinical trials and our cros-functional global teams.

clinical research associate oncology jobs

Advanced Technology

We recognize the importance of first-time quality to bring treatments to patients faster.

Learn About Our Culture

clinical research associate oncology jobs

Neuroscience Careers

Neuroscience diseases affect the very core of one’s being and experience. We work diligently to lighten the burden for patients and families alike. Explore opportunities to join our team.

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Parexel's Newsroom

Read our corporate news, press releases, as well as our ESG report.

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Careers in Inflammation & Immunology

Each day, we’re working toward building a deeper connection and understanding with those who count on us – the patients.

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Cell and Gene Careers

Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space.

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Our work culture

Learn about our culture, perks, learning opportunities, and our corporate responsibility approach.

clinical research associate oncology jobs

Careers in Oncology

Our dedicated people, innovative approaches, and culture of caring all work together to ease the journey for patients and investigators.

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Careers in Rare Diseases

In rare disease, every single patient is precious. Discover where your skills can create a life-changing achievement for every person involved.

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Emerging Talent Programs

Begin your career journey at Parexel with our emerging talent programs or our internships, placements and apprenticeships. Advance science by keeping the patients at the heart.

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How to Apply

It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful.

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Getting the most out of learning at Parexel

We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career. Ensuring we have a fully trained and capable workforce is a key part of delivering quality work and patient safety.

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Benefits & Support

Review how we fit work into our lives, make sure good work is seen, and thrive on a collaborative spirit.

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Diversity, Equity & Inclusion

Find out more about how we live our DE&I pillars: Patients, People, and Suppliers.

Female black CRA working on a clinical trial, concentrated looking down and filling out a form, sitting in a cubical.

Join our APEX Program and become a Clinical Research Associate (CRA)

The goal of the APEX Program is to provide foundational clinical research training - including project and system experience - to individuals wanting to become a CRA but are recent college graduates and have less than a year of monitoring experience.

Mwango: SVP & Global Head of Regulatory Strategy

Meet Mwango: SVP & Global Head of Regulatory Strategy

Mwango shares how she came to Parexel after spending 16 years at the FDA to experience the process and considerations from the drug developer’s perspective. Read about her role as a VP-Technical and what valuable advice she offers to those looking to work With Heart™.

What is a Clinical Research Organization?

A Clinical Research Organization (CRO) is a company contracted by a pharmaceutical, biological or medical device manufacturer to manage clinical research studies and other services to support product development. Learn about the four phases of clinical trials.

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From Clinical Operations Leader to Director: Catia's path at Parexel

Catia discusses her impressive 15-year career progression at Parexel. Learn from her experiences and insights into people management, the importance of support, and advice for Clinical Operations Leaders.

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Meet Cheng Cai: Director, Clinical Pharmacology Modeling and Simulation (CPMS)

Cheng is passionate about advancing clinical research and improving patient outcomes. He enjoys collaborating with his talented team and building mathematical models in his role. Outside of work, he leads an active lifestyle and values quality time with his family through various activities.

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Roles within Project Leadership

Join Parexel's Global Project Leadership group, comprising 500+ employees in 35 countries and drive success for Enterprise and Biotech clients. With our dynamic team structure, management systems, training, and support, you'll have the tools and expertise to excel as a Project Leader and contribute to life-changing therapies.

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Follow us on Social Media

Parexel is present on several social media channels where we post our latest updates. Follow, interact, and rate us!

Global Medical Writing Team

Roles within Medical Writing

Make a difference with a role in Medical Writing

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Flexible Work Arrangement

In-office, home-based or a mix? What’s your preference? We value the work-life balance of our employees, and as such Parexel is offering maximum flexibility to our employees wherever possible.

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Roles within Clinical Operations

Are you passionate about making a difference in the fight against cancer and beyond? At Parexel's Global Clinical Operations, we are dedicated to putting patients at the heart of every clinical trial. With a global footprint and 5000 Clinical Operations team members worldwide, we are impacting clinical research.

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Christine and Ewa share what a Project Leader does, why to become a Project Leader, and what mindset is needed. Explore how a Project Leader resembles a cheerleader or a coxswain of a rowing boat!

Lola

Meet Lola: Senior Clinical Research Associate

Lola shares about her position as a Senior Clinical Research Associate (Sr. CRA), what skills are needed for her role, and what she enjoys outside of work!

Stephanie, Director, Regulatory Affairs (USA)

Meet Stephanie: Director, Regulatory Affairs (USA)

Stephanie is leading a team and providing regulatory consulting for a variety of medical device clients. In this interview, Stephanie talks about her role, the projects she works on, and her passion for helping clients address unmet medical needs.

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Roles within our Functional Service Provider devision

Within our outsourcing model, you are deployed as an experienced colleague for our customers, benefiting from exposure to both the clinical research organization (CRO) and sponsor experience.

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Roles within Data Operations

Impact patients with a role in Biostatistics, Statistical Programming and Data Management.

David, Executive Director, Business Development & Co-Lead Disability Steering Committee

Meet David: Executive Director, Business Development & Co-Lead Disability Steering Committee

David shares what is involved to get the right research solution to clients and patients. As a differently-abled person, he talks about his experience and achievements whilst working at Parexel.

Amrita, Manager in Statistical Programmer

Meet Amrita: Manager, Statistical Programmer

Amrita tells us about how Parexel has helped her grow within her career with working flexibility and opportunities to learn.

Janice, Principal Statistical Programmer FSP

Meet Janice: Principal Statistical Programmer FSP

Janice You shares why she choose Parexel FSP. Find out which skills are needed in her role, what she enjoys the most, as well as what challenges her.

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Meet Neha: Senior Biostatistician

Neha describes her role as a Senior Biostatistician and why she chose Parexel.

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Meet Gabriela: Project Specialist II

Read how Gabriela, as a Project Specialist, is contributing to the achievement and compliance of study deliverables to benefit our common goal of bringing a new therapy to patients.

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Meet Rahul: Senior Health Economics Associate

Rahul describes his role as a Senior Health Economics Associate in the Health Economics and Outcomes Research team

Joanna, Senior Medical Writer

Meet Joanna: Senior Medical Writer

Joanna provides insights about her role as a Senior Medical Writer. She describes what excites her about the role and what it is like working with highly educated, motivated, and professional colleagues.

Mary, Principal Medical Writer

Meet Mary: Principal Medical Writer

Mary provides insights about her role as a Principal Medical Writer. She shares what it is like working with her fellow colleagues, how Parexel has supported her career development, and what excites her most about the work she does.

Parexel Military Talent Community

Parexel Military Talent Community

We know ‘serving’ is a core value of many of our military community. At Parexel, you can continue on your mission to serve, by joining an organization dedicated to improving the lives of patients worldwide. The skills and values you have developed in your military career or as a military spouse are transferrable to meaningful careers here at Parexel.

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View how Christina reflects on her work experience, her impact on patients and her management style of respect and growth. Christina is leading a team of Clinical Operations Leaders who manage groundbreaking trials in the biotech space.

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Meet Steve Cipollone, a Director within our Data & Technology group motivated by the impact his work has on patients.

Steve started as an intern and now leads the team that supports the technology tools he helped build during his early years at Parexel. Discover how his passion for resilient technology solutions is making a difference in global clinical trials and transforming patients' lives worldwide.

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Meet Chrishni, a Senior Project Leader with an exciting global journey

Discover Chrishni's inspiring journey at Parexel, where her love for France led her to relocate from Australia and thrive in her career based in Lyon. She enjoys collaborating with her team and finding a harmonious work-life balance to indulge in her passions.

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Meet Doreen, a Project Leader focusing on patient-centric research

Explore Doreen's journey as a Project Leader at Parexel, where she embraces her role in improving patient materials and ensuring patient-friendly and inclusive studies. Additionally, learn about Doreen's onboarding process, her Line Manager's support for work-life balance, and how she enjoys adventures with her children.

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Meet Theodora : Site Contract Leader

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Meet Xin Ni: Clinical Data Analyst I

Xin Ni joined Parexel Malaysia as Clinical Data Analyst Intern since 2022, and was shortlisted and hired as a permanent Clinical Data Analyst I (CDAI). Let’s visit her story in the data management team and get more insight of Gen Z workers, The Future Innovators.

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Meet Marije, a Clinical Operations Manager who's most proud of becoming a people leader

Marije, a former nurse, is dedicated to enhancing patients' lives through her involvement in clinical research. Marije's exceptional leadership skills and impressive career growth further highlight her as a motivating individual.

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Meet Adrian, a Site Care Partner navigating the complex landscape of clinical trials.

Adrian works as an outsourced Site Care Partner (SCP) for a client within the pharmaceutical industry. Learn more about Adrian's experience and insights on how he contributes to the success of clinical trials.

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Meet Rachel Smith: Global Head of Rare Disease, CoE

Rachel advocates for rare disease patients and drives innovation in clinical trials at Parexel. Her own diagnosis gives her a unique perspective on patient experiences and outcomes. Discover Rachel's inspiring projects and her dedication to advancing rare disease research.

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Meet Jessica, an Associate Project Director guiding trials through the complex regulatory landscape

Jessica works as an Associate Project Director within our Regulatory and Access Global Project Leadership team. Learn more about Jessica's experience and how she contributes to the success of clinical trials.

clinical research associate oncology jobs

Meet Anthony, a Senior Principal Medical Writer contributing to lifesaving treatments and therapies

Anthony's has worked as a Medical Writer for more than 17 years. In his current role as Senior Principal Medical Writer, discover how Anthony's work contributes to therapy development and clinical trials.

Chanakarn, Clinical Research Associate II

Meet Chanakarn: Clinical Research Associate II

Charnakarn talks about what it is like to be a CRA, and the support she has been given to achieve her career goals.

Ashwini, Manager, Medical Writing Services

Rebuilding Careers: How Ashwini rediscovered her confidence at Parexel

Meet Ashwini Somayaji, Senior Manager for Medical Writing Services. Ashwini's career took an unexpected turn with a five-year break. However, her determination and passion led her to Parexel, where she reignited her professional aspirations. With the support and guidance of her colleagues, Ashwini's journey became one of rebuilding confidence and career growth.

Marlayna, Senior Clinical Research Associate

Returning with Passion: What Marlayna experienced coming back to Parexel

After a brief departure, Marlayna joined as a Senior Clinical Research Associate and transitioned later into being a field coach and mentor for new CRAs. When returning Marlayna discovered a company more committed than ever to employee well-being and belonging.

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Meet Sheryl: Principal Consultant, Regulatory & Access

Sheryl, Principal Consultant, talks about why she joined Parexel and how she keeps the patient first.

Kanika, Manager in Project Manager

Meet Kanika: Manager in Project Manager

Kanika describes her role within finance operations and why she chose to join Parexel

Cheri & Tarryn, Project Specialist II

Meet Cheri & Tarryn: Project Specialist II

Cheri and Tarryn are sisters and Project Specialists at Parexel South Africa. Learn about their lives, roles and the culture of the Project Planning & Support (PPS) department.

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Meet Jamie: Diversity & Inclusion

Jamie offers her perspective on Parexel’s inclusivity to LGBTQ+ colleagues, how she feels about being "out" at work, and more.

Kirill, Executive Director, FSP Biometrics

Meet Kirill: Executive Director, FSP Biometrics

Kirill describes what excites him about his role and how he tries to challenge and encourage his staff.

Santino, Clinical Operations Leader

Meet Santino: Clinical Operations Leader

Santino's career at Parexel, from a Project Specialist to a Clinical Operations Leader, showcases a diverse journey through Clinical Operations, fueled by a passion for the pharmaceutical industry and a commitment to impacting patient lives. His experience highlights Parexel's dedication to professional growth and the embodiment of the "We Care" promise in every facet of their work.

Siddhika, Clinical Data Analyst III

Meet Siddhika: Clinical Data Analyst III

Meet Siddhika, Clinical Data Analyst III as she explains why she decided to apply to Parexel after a six year career break

Jitender, Director, Health Economics

Meet Jitender: Director, Health Economics

Jitender describes his role as a Director, Health Economics, supporting our clients with strategic recommendations and delivering the value story of new treatments.

Jagan, Director, India Assistant Compliance Officer

Meet Jagan: Director, India Assistant Compliance Officer

Jagan describes his role as a Director within the compliance team based in India

2022 Catalyst Award winner

Catalyst Award Winner 2022

Catalyst is advancing workplaces that work for Women - Parexel was recognized for "Leveraging Gender Partnership to Advance Women in Leadership."

Jennifer, Associate Director, Scientific Services, MedCom

Meet Jennifer: Associate Director, Scientific Services, MedCom

Jennifer discusses her role as an Associate Director, Scientific Services in Medical Communications, and the challenges she enjoys.

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Meet Simona: Principal Consultant, Regulatory & Access

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Clinical Research Associate, Oncology

Clinical Research Associate (CRA), Oncology,

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

As a Field Based Clinical Research Associate , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

In this role as an Oncology CRA , you will have the local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). You’ll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.

You will also be responsible for the preparation, initiation, monitoring and closure of an agreed number of centers in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials. 

Minimum Requirements:

  • Bachelor’s degree required, preferably in Life Science field
  • Minimum 2 years of CRA experience in Oncology therapeutic experience required
  • Fluent knowledge of spoken and written English
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP
  • Good knowledge of relevant local regulations
  • Good medical knowledge in relevant AZ Therapeutic Areas
  • Basic understanding of the drug development process
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management
  • Ability to travel as required, 50-70%

Competencies and Skills:

  •  Ability to deliver quality according to the requested standards
  •  Ability to work in an environment of remote collaborators
  •  Manages change with a positive approach for self, team, and the business. Sees change as an   opportunity to improve performance and add value to the business
  •  Ability to look for and champion more efficient and effective methods/processes of delivering quality  clinical trials with a reduced budget and in less time
  •  Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills
  • Good analytical and problem-solving skills
  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
  • Good cultural awareness
  •  Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment
  •  Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities

Working at AstraZeneca

Here you’ll have the chance to create a substantial difference to patients’ lives! With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.

Next Steps? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Find out more and follow AstraZeneca on: 

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AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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At AstraZeneca, our purpose is to help patients all over the world by delivering life-changing medicines as one collaborative team.

The success of AstraZeneca is founded on innovation, creativity and diversity. Discover what this means for you.

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Discovery & Pre-Clinical/Clinical Development

Senior Clinical Research Associate

  • Job Title Senior Clinical Research Associate
  • Function Discovery & Pre-Clinical/Clinical Development
  • Sub Function Clinical Development & Research & Non-MD
  • Location Danvers, MA, United States; United States
  • Date Posted Feb 22 2024
  • Requisition Number 2406171534W

Description

Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Clinical Research Associate.  Remote work options may be considered on a case-by-case basis and if approved by the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.                  

Reporting to the Manager, Clinical Research Associates, the person in this role is responsible for the management of day-to- day aspects of investigational site activities on assigned clinical trials. The Senior Clinical Research Associate should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as part of a collaborative team. This person will be fully engaged and busy from the first day and we guarantee there will never be a dull moment. Our team focuses on future development of the Impella platform, including clinical studies, data science and new clinical and physiological applications.

Qualifications

Key responsibilities:.

  • Coordinate study start-up and study conduct activities, including: drafting ICF study specific template and TMF plan, approving study-specific essential documents list, managing and communicating the status of study progress and activities
  • Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution.
  • Mentor and train junior employees
  • Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
  • Lead in assessing current and new processes, finding opportunities and implementing solutions to improve efficiencies within and across related functional areas
  • Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations
  • Prepare materials for steering and investigator meetings
  • Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
  • Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
  • Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
  • Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees.
  • Provide oversight of and insight into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
  • Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
  • Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition.
  • Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
  • Edit/amend informed consent documents.

Qualifications:

  • Bachelor's Degree in a related Science field
  • 5 years of field monitoring experience
  • Experience working in medical device industry
  • Excellent written and verbal communication, presentation, interpersonal, and analytical skills
  • Proven problem-solving and critical thinking skills
  • Demonstrated expertise in MS Office Suite, including Word, Excel, Adobe
  • Ability to travel up to 65%
  • Previous experience working at medical device Sponsor 
  • Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification)
  • Must upload written cover letter with application submission

This job posting is anticipated to close on 3.13.2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. 

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $100,000 to $135,000. The Company maintains highly competitive, performance-based compensation programs.  For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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除强生中国或法律特别要求外,请您避免在您的申请中提交可能会被视为敏感个人信息的信息,即生物识别、宗教信仰、特定身份、医疗健康、金融账户、行踪轨迹,以及不满十四周岁未成年人的信息等一旦遭遇泄露或非法使用,容易导致人格尊严受到侵害或者人身、财产安全受到危害的个人信息。

Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual’s personal dignity or harm to personal or property safety.

前述境外接收方为:美国强生公司(Johnson & Johnson Services, Inc.),其联系方式为:美国新泽西州新不伦瑞克市强生广场一号。

The overseas recipient is Johnson & Johnson Services, Inc., which can be contacted at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, U.S.

境外接收方将按照如下目的和方式处理您的个人信息。

The overseas recipient will process your personal information in accordance with the following purpose and method:

  • 处理目的:根据强生全球集团“统一人力资源(One HR)”原则,对人才招募进行全球统一管理,具体请参见《应聘者隐私政策》中“我们收集此类个人信息的原因”部分。

Processing Purpose: Conduct talent acquisition management globally following the One HR principle of the Johnson & Johnson Family of Companies, as described in the “Reasons We Collect This Information” section of J&J’s Careers Privacy Policy.

  • 处理方式:通过统一流程和全球互联应用实现对人才招募的统一管理,涉及存储、使用、加工、传输、删除已出境个人信息。境外接收方将采取适当的管理和技术措施保障出境个人信息的机密性、完整性和可用性,并将在完成上述目的最小必要范围内保存出境个人信息。

Processing Method: Conduct talent acquisition management through the unified process and globally connected applications, including storage, use, handling, transmission, and deletion of provided personal information. Overseas recipients will apply appropriate managerial and technical measures to ensure the confidentiality, integrity, and availability of the provided personal information and shall store such personal information to the minimum extent necessary to complete the above purposes.

您可以通过[email protected]联系强生中国公司的个人信息保护官以向境外接收方行使您享有的相关权利,包括要求访问、更正、复制或删除您的个人信息。

You may contact the Personal Information Protection Officer of the J&J China at [email protected] to exercise your relevant rights to the overseas recipient, including access, correct, copy, or delete your personal information.

鉴于强生全球集团业务的全球化经营性质,当您向强生中国 应聘职位时,强生中国会向境外接收方及其经授权的第三方提供您的个人信息。具体而言:

除强生中国或法律特别要求外,请您避免在您的申请中提交可能会被视为敏感个人信息的信息,即物识别、宗教信仰、特定身份、医疗健康、金融账户、行踪轨迹,以及不满十四周岁未成年人的信息等一旦遭遇泄露或非法使用,容易导致人格尊严受到侵害或者人身、财产安全受到危害的个人信息。

Due to the global nature of the operation of the Johnson & Johnson Family of Companies, in the course of processing your application with J&J China, J&J China may provide your personal information to the overseas recipient and authorized third parties. Specifically:

[1] 在本个人信息出境同意函中,“强生中国”是指与您申请的职位所属的强生全球集团内具体公司。强生全球集团指美国强生公司(Johnson & Johnson Services, Inc.)以及其在世界范围内的关联公司,包括强生中国。

In this Employee Consent Letter, “J&J China” means the company in the Johnson & Johnson Family of Companies which you applied for, and “Johnson & Johnson Family of Companies” means Johnson & Johnson Services, Inc. and its worldwide affiliates, including J&J China.

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Clinical Research Associate (Client Onsite) - CRA - Moscow

🔍 moscow, russia, russia.

  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Effective independent clinical monitoring skills ;
  • Excellent understanding and demonstrated application of GCPs and applicable SOPs
  • Management of regulatory and / or IEC questions
  • Development and preparation of the local informed consent form
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Management of the delivery of study supplies
  • Strong customer focus
  • Effective interpersonal skills
  • Strong attention to detail
  • Effective organizational and time management skills
  • Proven flexibility and adaptability
  • Ability to work in a team or independently as required
  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English language and grammar skills
  • Good presentation skills  
  • Requisition ID: 126817

Stanford University

Clinical Research Coordinator Associate

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

The Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine (PAACM) is seeking a full-time (100% FTE) Clinical Research Coordinator Associate (CRCA) to coordinate multicenter clinical trials investigating plasma and lung biomarkers, and emerging therapies for patients with sepsis, pneumonia, and lung injury. These studies are conducted at the Stanford Hospital and Clinics, often involving patients in the intensive care unit.  The CRCA will work as part of a highly committed clinical trials research team and report to the Clinical Research Manager and various Principal Investigators conducting clinical research within the Pulmonary, Allergy & Critical Care Medicine Division. The position requires a desire to work in a fast-paced environment of an acute care setting as part of a multidisciplinary team that includes MDs, RNs, and RTs, and other research coordinators.  The position will require superior organizational skills to ensure rigorous and timely compliance with multiple clinical trial protocols and adherence to regulatory standards. Responsibilities include screening and enrollment of subjects, and implementation of study protocols in accordance with Good Clinical Practice guidelines, and collection and maintenance of complete data files in accordance with HIPAA regulations. This position will also be responsible for overseeing activities related to acquisition, processing, storage and organization of human materials, including serum.  Experience in sample processing, some flexibility in work hours, and knowledge of computer programming/data analysis are preferred.

Duties include:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from start-up 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.

DESIRED QUALIFICATIONS:

  • Interest in learning about clinical study design/implementation and about the care of critically ill patients.
  • Ability to coordinate research protocol activities in a fast-paced, high-stakes environment like the intensive care unit.
  • Willingness to learn how to handle specimens for shipping and willingness to learn basic processing of biospecimens for storage.
  • Strong interpersonal skills to communicate with patients and their surrogates in the context of the patient’s critical illness, as well as interact with treating physicians, nurses, pharmacy and other health care providers.
  • Willingness to learn about Institutional Review Board (IRB) policy and practice, including the informed consent process.
  • Timely communication with IRB regarding Serious Adverse Event (SAE) reports protocol violations, and amendment reviews and revisions.
  • Aptitude for medical record review.
  • Responsible record keeping, including the retention of source documentation for all study data, including laboratory, pharmacy and medical records.
  • Good computer skills (able to use Microsoft Word and Excel).
  • Experience in all phases of industry-sponsored and NIH funded clinical trials.
  • Experience with REDCap, EPIC and OpenSpecimen (or similar biospecimen management system)
  • Experience in sample processing, and knowledge of computer programming/data analysis would be highly desirable but not required.
  • Fluency in Spanish
  • Preference for applicants who envision 2 years in the position.

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:

  • Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.

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.

WORKING CONDITIONS:

  • Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
  • May require extended or unusual work hours based on research requirements and business needs.

WORKING 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 $27.88 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.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Why Stanford is for You

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

  • Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
  • A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
  • A healthier you. Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
  • Discovery and fun. Stroll through historic sculptures, trails, and museums.
  • Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at [email protected]. For all other inquiries, please submit a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

  • Schedule: Full-time
  • Job Code: 1013
  • Employee Status: Regular
  • Requisition ID: 102669
  • Work Arrangement : On Site

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