clinical research associate training south africa

Learn more about our exceptional training courses

Available Courses

ACRO is committed to building clinical research capacity on the African continent and has developed a range of training courses and services to meet this need. Here’s what we have to offer:

*All courses are offered face-to-face, and where applicable via Microsoft Teams.

Our courses are offered based on demand, and will be conducted with 6 or more attendees.

Groups of 10 attendees or more will qualify for a discount on selected courses.

Fees include VAT.

Clinical Team Training

ACRO’s CTA training is aimed at individuals who would like to enter the clinical trial environment, as a clinical trial assistant/administrator at pharmaceutical companies, contract research organisations or other companies within the research environment. Individuals who would like to attend this course should have a grade12/senior certificate, as well as basic computer skills. During this 2 day course attendees will be exposed to administrative theory, as well as group and individual exercises.

ACRO’s SCRA training includes both theoretical and practical components. This 2 day course is aimed at individuals who have a minimum of three years’ experience as a CRA and who have performed monitoring visits at each stage of a clinical trial, i.e. start-up, initiation, interim and close out visits and submitted applications to ECs and/or SAHPRA. Course attendees will have a relevant, industry recognised tertiary qualification and intermediate computer skills. If the individual does not meet the criteria above to be able to attend the course, a letter of recommendation/motivation from the company should be submitted.

ACRO’s Clinical Research Project Management training is a 3 day course aimed at individuals who are currently employed in the clinical trial environment, ideally in a managerial position or will be taking up such position soon.

The training includes both theoretical and practical components and its main focus is on management within the clinical research environment.

Course attendees will have a relevant, industry-recognised tertiary qualification and intermediate computer skills

Clinical Research Associate Training

Ideally, this course is aimed at people who have an Industry recognised tertiary qualification, and at least two year’s trial experience as a member of staff e.g. study coordinator at an investigative site, or one year experience as a CRA or internal monitor.

Learner’s wishing to attend this accredited course must have completed an industry recognised Good Clinical Practice course prior to attending this CRA course. Classes are limited to 12 delegates so as to provide individual attention.

Data Management Training

This course has been tailored specifically for Clinical Staff working at Investigative Sites. It is designed to give Clinical Site Staff specialised skills and knowledge of the management of clinical data used in clinical trials which will increase their efficiency, effectiveness, capacity and competence. Candidates for this training require no experience as a Clinical Data Manager; however, it is preferable that they have worked in a Clinical Research Environment as a Clinical Research Nurse, CRA, QC/QA Officer, Research Administrator, or Project Administrator. The course includes practical exercises and a final evaluation to encourage understanding. A certificate of attendance will be awarded. 

This course provides an excellent introduction to clinical data management in the pharmaceutical industry. It is specifically tailored for Staff of Pharmaceutical Companies, Contract or Independent Research Organisations whose function is to review, correct, enter, or manage data and who have less than two years’ experience in that function. It will also benefit other individuals who wish to learn basic clinical data management skills and to understand the function of clinical data management in the drug development process. The course includes practical exercises and a final evaluation to encourage understanding. A certificate of attendance will be awarded. 

This course aims to builds on the skills and knowledge covered in the ACRO Introduction to Clinical Data Management training and is specifically tailored for Staff of Pharmaceutical Companies, Contract or Independent Research Organisations who are experienced Clinical Data Managers and are looking to expand the scope of their knowledge to increase their efficiency, effectiveness, capacity and competence. Prerequisites for this training are that delegates have attended the ACRO Introduction to Clinical Data Management Training or that they have more than two years’ experience in a clinical data management environment and are familiar with the subjects covered in our introductory training. The course includes practical exercises and a final evaluation to encourage understanding. A certificate of attendance will be awarded. 

Good Clinical Practice Training

ACRO’s accredited GCP training for investigative sites includes both theoretical and practical components. Delegates are exposed to theory, role play, group work, and individual learning exercises. This introductory 2 day course is aimed at site personnel at a beginner to intermediate level of clinical trial experience. Wherever possible, study specific materials are used to optimise learning relevant to the clinical trial about to be undertaken. ACRO also provides 1 day refresher GCP courses.

Each course is based on ICH-GCP and local regulatory requirements; instruction on FDA regulations is added when required.

ACRO also provides introductory and refresher GCP training for Clinical Research Associates (CRA) and other members of the clinical team.

Trial Site Development & Training

Working with the site and sponsor, ACRO’s experienced team offer training and mentoring to potential and established clinical trial sites. The training is modular and can therefore be adapted to meet the specific needs of a site to ensure trial preparedness.

ACRO can develop a site from scratch or provide focused training to consolidate the knowledge of staff at an established site. Development assistance may include identifying facility and staffing needs, sourcing site infrastructure, assisting in the creation of site processes and SOPs, drafting job descriptions, and other activities.

Training blends theory and practice, and may include, amongst other areas and topics, the following: administrative training; monitor training and mentoring; the conduct of non-interventional protocols; the establishment of Community Advisory Boards; participant recruitment and retention; and GCP support. Local input is sought to ensure that all training that is given is implementable, and all suggested solutions are feasible.

GCP and Clinical Research training

CREDE’s courses are developed, facilitated and presented by knowledgeable and experienced research professionals and practitioners in the research field.

CREDE is an independent organization that provides GCP and other clinical research training courses.

We are focused on the clinical research environment in South Africa and the rest of Africa. Our courses and workshops are unique in that they are based in experience, packed with relevant and useful content, and presented in a fun and interactive way. Yes, even GCP can be fun! Our courses are accredited by the HPCSA and meet the national requirements for GCP courses in SA.

Our Courses

Gcp beginner course.

A well-rounded introductory GCP course covering the basics and so much more. This course is for  those who do not have a VALID SA GCP certificate or who have never done a GCP course before.

GCP Refresher course

A stimulating touch-up GCP course for those with a current valid SA GCP certificate that need to renew. The SA GCP guidelines as well as the ICH GCP are re-introduced to the learners.

SAGCP 2020 – UPDATE session

This short training session introduces the updated SA GCP version and points out the relevant changes and updates. The new SA GCP, 3 rd Edition, 2020, was published on 15 June 2021 on the SAHPRA website.

View All Courses

“Hands down the best managed course I have been on.”

“The printed material alone is worth the price of the course. Having the material presented over 2 days with interactive sessions by such a dynamic facilitator completely transformed what has previously been a rather stale topic met with moans and groans.”

“Thanks Marijke, I was coming expecting to be bored, I must be honest, I was pleasantly surprised at being interested the whole time – Think that your dynamic nature made a huge difference, I thoroughly enjoyed it and I remember stuff too.”

“Thank you very much for the excellent facilitation that made GCP such an attraction….it’s no longer the dreaded ‘thing’ it used to be. I have done some GCP courses before but this is the best of them so far.”

“I thoroughly enjoyed the day, so much so that when I got home I started reading the Declaration of Helsinki and the SA GCP guidelines!!! I thought I couldn’t take the time out of the office but this was an excellent, informative, relaxed way to update my knowledge on a field I enjoy.”

“I think it is excellent as is. Will recommend it to my colleagues and students. Thank you for your assistance and excellent delivery of this course.”

“Organised, efficient and fun!! Exuberant personality.”

“Thanks so much for the wonderful course!! My head is full of MMED ideas & new considerations for ways in which to conduct these. I am immensely grateful…”

“Fun and interesting way to learn about GCP. Really excellent course.”

“I enjoyed it (Refr.course June 2012) very much. It exceeded my expectations.”

What are the current SA GCP guidelines?

The latest version of the South African Good Clinical Practice guidelines (SA GCP) is the 3 rd edition, 2020. On 15 June 2021 the updated SA GCP 3rd edition of 2020 was published on the website of the South African Health Products Regulatory Authority (SAHPRA). This version replaces the previous version.

The document has been completely redesigned from the ground up to align it with ICH GCP (R2) and current trends in the clinical research arena. The document needs to be read with the Ethics in Health Research, Principles, Processes and Structures (SA Dept. of Health, 2 nd Edition, 2015) policy document.

Can anyone provide SA GCP training and issue a GCP certificate?

No, GCP trainers in South Africa need to issue a GCP certificate that has been accredited by the Health Professions Council of South Africa (HPCSA). Accreditation involves a review of the course content as well as the skills, background, and expertise of the trainer.

“Experto crede” is a Latin term that means “have faith in experience.” We are passionate about clinical research. Our programmes are grounded in wide experience in the field and expert content knowledge.

What is research but a blind date with knowledge – William Harvey   (1578 – 1657)

Re-envisioned clinical research training

Foundations and Beyond – the Clinical Research Journey

Good Clinical Practice (GCP) Refresher

The Clinical Trial Life cycle – Training for Clinical Research Support Roles

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Why you should choose Task Research Academy

TASK has completed more than 80 successful early to late phase commercial and grant studies at their 5 research sites with various support teams now also fulfilling most CRO and sponsor responsibilities. Being part of this colourful journey enabled TASK Research Academy to identify the gaps and best ways of training within the industry.

We believe capacity is built by reimagining the way knowledge and skills are traditionally taught to clinical research staff. Our teaching methodology involves learners in experience-driven learning where they can immerse themselves in the world of clinical trials and learn what to do and why to do something at each stage of the clinical trial process. As a result, teams partnering with us will be learning from the best to become the best because TASK Research Academy believes in developing tomorrow’s clinical research professionals today.

TASK Research Academy firmly believes in developing tomorrow’s clinical research professionals today. Learn from the best to become the best!

What can you expect from our courses?

Interactive, in-depth and independently quality-assured content

Internationally accredited and assured

Designed by industry for industry

Simple, fun and easy to navigate.

Diverse mix of learning methods to keep you engaged.

Competency-based learning, to ensure you are industry-ready

Quality-assured and accredited training

No fixed enrolment dates. work online – on your own schedule, at your own pace – anywhere, anytime., accrediting bodies.

Frequently Asked Questions

I have 5 years’ experience as an investigator in clinical research. are task academy’s courses for me.

Yes, we have received positive reviews from people who have worked in the industry for over 20 years. As you start to work in the clinical research field, you usually get once-off GCP training, which is refreshed every three years. However, you typically work in a silo, and hardly ever get the opportunity to understand clinical trials from the perspectives of other role-players. Our courses go beyond compliance training by contextualising content within the full life cycle of a clinical study. 

Do the courses cover Good Clinical Practice (ICH GCP)?

Yes. Our Foundations & Beyond, and GCP refresher courses cover both ICH GCP and SA GCP.

Do the courses also cover SA GCP?

Yes. Our Foundations & Beyond as well as GCP refresher courses cover both ICH GCP and SA GCP.

I’m new to the industry, which course should I start with?

Our Foundations & Beyond course is the perfect starting point for you. Not only will you learn everything you need to be ICH GCP and SA GCP compliant, but you’ll learn how a trial is developed, set up, conducted, and closed and everything in between.

Can I take the GCP refresher course?

If you have had GCP training within the last 3 years, then you are eligible to enrol on our Refresher course. Please note we will need a digital copy of your most recent compliance certificate. If your certificate has expired for 3 months or longer, you are required to retake full GCP training.

I am looking to develop my career and get into clinical research but don’t know how to go about it. How do I move into the field and how can TASK Academy help me to achieve my goal of ultimately becoming a CRA?

It is quite difficult to enter this industry. To start with, as a minimum, you need a certificate in Good Clinical Practice (GCP). Our Foundations & Beyond course is GCP compliance on steroids, and after completing it, you will receive compliance certificates for both ICH GCP and SA GCP. The course is intense, but immersive, and will take you through the whole life cycle of a clinical trial. The course is internationally accredited, and will be the foundation of your career pathway to become a CRA.

Is Online Good Clinical Practice training accepted by SAHPRA and Ethics Committees?

Yes. Our comprehensive online courses are accepted by regulatory authorities in South Africa, and are accredited by HPCSA. They are independently quality assured by IAOCR (UK), accredited by ACCRE, and meet TransCelerate’s criteria for good clinical practice training.

I have no background in clinical trials. Can I do the courses?

Yes you can. ANYONE interested to start a career in clinical research, no matter what role you aspire to – sponsor, CRA, CTA, nurse, manager, coordinator, pharmacist, investigator, data capturer, data manager, regulatory authority, ethics board member, quality assurer, lab staff – our courses are for you.

I am a graduate and have no experience; does this course increase my chances of getting into clinical research?

Our courses are created by people who have worked in the industry for over 15 years. We cannot guarantee that you will get a job after taking our courses. However, what we can promise is that the depth of knowledge you’ve gained will set you apart from other candidates, as you can showcase your understanding of GCP, as well as the clinical trial language, life cycle, and role players. 

Do the courses have specific start dates?

TASK Academy’s courses run asynchronously, so you can start anytime.

How long do I have to complete a course?

While we advise students to complete the course within a few weeks of enrolling, you are able to work at your own pace and take as long as you need.

What do I need to access a course?

Any device that can connect to the internet – Android or iPhone; tablet, laptop, or computer. You will need medium to high-speed internet access, as there are videos and interactions.

Are there any prerequisites for the courses?

You must be able to read and understand standard business English. You do not have to have any experience in clinical research. You do not have to have a Good Clinical Practice certificate.

Is this just box-ticking compliance training?

No. TASK Academy courses are NOT your typical “death by Powerpoint” compliance training. While our courses encompass all the ICH GCP and SA GCP principles required to work in clinical research, they offer so much more! They are engaging and interactive, and contextualise lessons within the full life cycle of a mock Phase III trial. You will see the bigger picture, and learn how a trial is developed, set up, conducted, and closed and everything in between.

Developing tomorrow’s research professionals today.

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About SACRA

A Distinct Identity

The South African Clinical research association (SACRA)  is an industry community association with the sole purpose of leading and serving as a conduit within the clinical trials community. SACRA is a non-profit organisation representing the clinical research industry in South Africa.

SACRA's Purpose

To lead and serve as a conduit across the various stakeholders, positioning the country at the forefront of clinical research both nationally and internationally.

SACRA's Values

SCIENTIFIC-RIGOUR

INCLUSIVITY

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How to Become A clinical Research Associate South Africa

A clinical research associate, also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials.

Below are steps to to Become A clinical Research Associate South Africa

The pathways to becoming a clinical research associate are numerous and available to anyone with a high school diploma or higher. While formal education is not technically required to enter the field, having a bachelor’s degree or higher can make potential candidates much more competitive.

Certification in the field is also not required, but obtaining certification from the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP) can result in more opportunities and even more competitive salaries.

Finally, all aspiring CRAs are advised to check out the International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP) to get a feel for the professional expectations and responsibilities.

Here is how to become a CRA depending on one’s level of education:

PATH 1: EARN A HIGH SCHOOL DIPLOMA AND GAIN EXPERIENCE

Perhaps the most strenuous route to this career is becoming a certified CRA with a high school diploma and between 3,000 and 3,500 hours of qualifying work experience (depending on certification entity).

These candidates often start out in support positions assisting a more experienced or certified CRA with mundane tasks.

An entry-level worker can earn increased responsibilities through a demonstrated capacity to learn the regulations, protocols, and ethical considerations.

To qualify for the following CRA certification exams, high school graduates must:

SOCRA Category 1

Complete two full-time years of CRA work within five years, or 3,500 hours of part-time work

PATH 2: EARN AN ASSOCIATE DEGREE AND GAIN EXPERIENCE

Depending on the program, an associate’s degree of applied science (AAS) in clinical research can be a standalone degree or a stepping-stone to a bachelor’s or master’s.

Licensed vocational or practical nurse (LVN or LPN) programs are designed specifically for practical, job-ready skills and may qualify aspiring CRAs for the ACRP certification.

To qualify for the following CRA certification exams, associate degree graduates must:

SOCRA Category 2

Hold a “clinical research” degree

Complete one full-time year as a CRA or 1,750 hours part-time

PATH 3: EARN A BACHELOR’S DEGREE AND GAIN EXPERIENCE

Most entry-level clinical research associate positions require candidates to have a bachelor’s of science (BS) in a health-related field from an accredited four-year university. In some cases, programs are designed to add practical hours needed to qualify for certification tests.

Those interested in becoming a CRA can study nursing, health sciences, biological sciences, clinical research, clinical research administration, clinical research management, medical technology, or life sciences, among many other subjects.

To qualify for the following CRA certification exams, bachelor’s degree graduates must:

SOCRA Category 3

Hold a “clinical research” undergraduate degree

PATH 4: EARN A MASTER’S DEGREE FOR OPPORTUNITIES IN MANAGEMENT

A master’s program in clinical research is generally designed for those already working as CRAs to expand their skills or to advance into management or supervisory roles within the field.

However, for those with non-health science bachelor’s degrees who want to become CRAs, seeking a master’s of science in clinical research or a master’s of science in clinical research management could be a pathway to breaking into the field.

Because many of these programs are offered online, earning a degree is possible for even those students who need full flexibility of schedule to complete the degree.

Although requirements for admission into master’s programs vary, those looking to gain admission into a master’s of science for clinical research commonly need the following:

A bachelor’s degree

Official transcripts demonstrating specific coursework in science

A statement of purpose

Letters of Recommendation or Reference

What qualifications do I need to be a clinical research associate?

A clinical research associate will need a graduate or post-graduate degree in either nursing, life sciences or medical science.

One must have knowledge of at least one of the following subjects – anatomy, biology, biochemistry, chemistry, microbiology, toxicology, pharmacology, immunology, physiology.

How do I get a job as a clinical research associate in South Africa?

Clinical Research Associate roles usually require candidates to have experience in clinical research monitoring and a degree in a life science or other health-related discipline

. Although not usually necessary, a Master’s degree (MSc. or equivalent) or a PhD can be advantageous.

Is clinical research associate a good career?

If you have an interest in the medical industry but don’t want to work with patients directly, a career as a clinical research associate may be ideal for you.

With a strong earning potential and the ability to impact millions of lives by working on research trials, this job can be extremely fulfilling

How do I become a certified clinical research associate in South Africa?

ACRP Options 1 & 2

Complete 3,000 hours performing essential job duties or 1,500 hours of equivalent work experience requirements through ACRP certifications or approved clinical research degree programs accredited by the Council for Higher Education.

Submit a resume documenting and demonstrating job performance.

How do I prepare for a clinical research associate interview?

Below are our five tips to make sure that you are properly prepared for a clinical research job interview.

Get your resume in tip-top shape.

Prepare, prepare, prepare.

Do your research.

Review your past research.

Is the CCRC exam hard?

If this is something you are interested in, make sure you are as prepared as possible because the CRC exam is known to be very difficult. The difficulty of the exam is really why the CRC credential holds such an elite standard in the industry.

How long is CRA training in South Africa ?

10-Week Clinical Research Associate (CRA) On-Boarding Program.

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Africa Health Research Institute

• Adrie Steyn
• Alison Grant
• Collins Iwuji
• Frank Tanser
• Guy Harling
• Henrik Kløverpris
• Ingrid Bassett
• Janet Seeley
• Kobus Herbst
• Limakatso Lebina
• Mark Siedner
• Maryam Shahmanesh
• Moherndran Archary
• Mohlopheni Marakalala
• Natsayi Chimbindi
• Nceba Gqaleni
• Nigel Klein
• Nothando Ngwenya
• Nuala McGrath
• Philip Goulder
• Thumbi Ndung’u
• Till Bärnighausen
• Zaza Ndhlovu

Academic training programme

AHRI is committed to creating education opportunities that will enhance medical and scientific research in South Africa and the rest of the African continent.

The Africa Health Research Institute (AHRI) offers an academic training programme that facilitates skills development and career progression for trainees (masters, PhD, and postdoctoral and clinical fellows), research associates and faculty. AHRI trainees, research associates and faculty are equipped with scientific and other skills relevant to tackling global health and socioeconomic challenges.

AHRI faculty members, supported by the academic training team, are primarily responsible for the mentorship and training of their students and postdocs. On arrival at AHRI a personal training plan which considers career goals is developed with the trainee. In addition, AHRI’s leadership development training offers modules including biostatistics, scientific citizenship, academic writing, and training in core skills such as setting up collaborations, project and time management, and strategic career planning. Trainees are also required to complete an NIH recognised ethical research and good clinical practice registration. Travel awards are available to support additional training needs.

Faculty Faculty are recruited by the director and the executive committee to lead research in specific disciplines aligned to the institutional strategy. Faculty are expected to attract external grant funding to support their research and scholarly activities.

Research associates Research associates are established researchers working under the mentorship or supervision of faculty. Research associates are expected to attract grant funding to complement faculty support or to begin transition to independent programmes.

Postgraduate research Read more about AHRI’s postgraduate research programme, encompassing postdoctoral fellows, PhD students, and masters students, here .

SANTHE The sub-Saharan African Network for TB/HIV Research Excellence (SANTHE) is a flagship programme of the Africa Health Research Institute that focuses on African and global collaborations to enhance research and capacity building in HIV, TB and associated comorbidities.  Currently, SANTHE has several African partner sites, with AHRI as the lead institute. The overall goals of SANTHE are to:

• Enhance research on HIV, TB and associated morbidities
• Shift training focus to leadership development
• Strengthen partner institutions for intellectual and financial independence
• Transform approaches to community and public engagement for impact

We are here to help

If you have any questions about AHRI’s education and training programme, or postgraduate research opportunities, please contact [email protected]

How to Become A Clinical Research Associate South Africa

A clinical research associate, also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials.

Below is How to Become A Clinical Research Associate South Africa

EARN A HIGH SCHOOL DIPLOMA AND GAIN EXPERIENCE

EARN AN ASSOCIATE DEGREE AND GAIN EXPERIENCE

EARN A BACHELOR’S DEGREE AND GAIN EXPERIENCE

EARN A MASTER’S DEGREE FOR OPPORTUNITIES IN MANAGEMENT

What qualifications do I need to be a clinical research associate?

A clinical research associate will need a graduate or post-graduate degree in either nursing, life sciences or medical science. One must have knowledge of at least one of the following subjects – anatomy, biology, biochemistry, chemistry, microbiology, toxicology, pharmacology, immunology, physiology.

How do you get a CRA job?

Clinical Research Associate roles usually require candidates to have experience in clinical research monitoring and a degree in a life science or other health-related discipline. Although not usually necessary, a Master’s degree (MSc. or equivalent) or a PhD can be advantageous.

Is clinical research associate a good career?

If you have an interest in the medical industry but don’t want to work with patients directly, a career as a clinical research associate may be ideal for you. With a strong earning potential and the ability to impact millions of lives by working on research trials, this job can be extremely fulfilling.

How do I start a career in clinical research?

A clinical research job will often require education to degree level in a related subject. However there are some opportunities for school leavers and apprenticeship programs may be available in some countries which allow people to study for degrees or equivalents and gain work experience at the same time.

Do you need a degree to be a CRA?

Most entry-level clinical research associate positions require candidates to have a bachelor’s of science (BS) in a health-related field from an accredited four-year university. In some cases, programs are designed to add practical hours needed to qualify for certification tests.

How much do CRAs travel?

Also note that most CRAs travel 60-80% of the month, which translates to 12-16 out of 20 business days a month and on occasion the weekends (although that is less common); thus, you may not be so readily available if an emergency occurs that impacts your family.

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3rd Annual African Emerging & Established Researcher Training Academy

Thank you to everyone who attended the Training Academy. Please note that certificates will be issued by the end of October 2022.

Dear Participants and Presenters,

The Human Sciences Research Council (HSRC) in partnership with the University of Pretoria, Sol Plaatje University and the University of Zululand take pleasure in hosting your participation in this annual five-day Virtual Training Academy for Emerging and Established African Research Scholars.

The objectives of the Academy are to:

• promote awareness of the importance of research among African scholars;
• expose emerging and early career scholars to a career in research;
• promote the development and enhancement of research and related skills among scholars.

A key mandate of the Human Sciences Research Council (HSRC) is to support capacity development for research in South Africa and on the African continent. It seeks to advance this mandate through promoting:

• Promote a career track in research among emerging and established researchers in South Africa and across the continent;
• Support research capacity development in research, research methods, research communication and science communication;
• Improving equitable access to marginalized groups such as women and the disabled persons; and
• Contributing to life-long learning.

Who is the Academy open to?

The Academy is open to African scholars from South Africa and/or other African countries. The specific target group are post-graduates including master’s Interns, PhD Interns, Post Doc Fellows and Lecturers currently studying or based at higher education institutions, science councils and in research related roles in public institutions. A requirement is a level of fluency in English as no translations will be provided.

It is hoped that trainees will be recruited from at least the three participating universities namely University of Zululand (UNIZULU), Sol Plaatje University (SPU) and the University of Pretoria (UP). Negotiations are underway to include other HEI institutions.

Application to Participate in the Academy

Registration to participate is required. For each session participants will be required to indicate which modules they wish to attend as there will be parallel tracks on four days. In order to ensure that the training covers broadly the needs of trainees a needs expectation exercise will be undertaken.

Requirements to Participate

Learners are expected to have access to a laptop/desktop computer, stable internet accessibility and sufficient data for the online sessions. The Academy does not offer data for participants. The online learning platform to be utilized is Microsoft TEAMS. A link to the Academy webpage will be shared and participants will be able to access the following via the webpage namely the Academy Schedule, Session Outlines, profiles of presenter and access to learning materials.

MS Teams allows 300 people to attend the webinar directly. Any additional person wishing to attend the workshop, will be able to do so via streaming.

Academy Programme

The virtual academy will be held over 5 days, with the 1st day being comprised of modules which all participants are expected to attend. Days 2 to 5 will have parallel tracks to allow participants to select specific modules for which they would like more in-depth training.

Academy Sessions will commence at 09h00 daily and terminate at 16h00. There will be a lunch break for 30 min and two stretch/tea breaks of 15 min daily.

Themes to be covered include:

• Research Design and Conceptual Frameworks
• Introduction to Quantitative data collection and analysis including use of data analysis software – STATA and SPSS
• Introduction to Cross-Sectional Data Analysis
• Introduction to Qualitative data collection & Analysis including the use of Atlas it/NVivo
• Ethics of social research
• Conducting literature reviews, searching for literature and use of reference tools
• Scientific communication: Academic writing for publications
• Innovations in science communication – Using Infographics
• Innovations in qualitative research

Programme Presenters and Facilitators

The Academy modules are facilitated and presented by established researchers within the HSRC and our partner institutions namely University of Pretoria, Sol Plaatje University and University of Zululand. As part of our commitment to developing research capacity among junior researchers several junior researchers will also be serving as facilitators and co-presenters. Bio-sketches will be provided on the webpage.

We acknowledge with deep appreciation the contributions of presenters and facilitators who give their time freely in pursuit of developing research capacity.

Course Material

Course materials will be made available on Academy Webpage, for your perusal before and during the academy as well as for a limited time after the academy. You are welcome to download these resources. If you wish to share resources, please feel free to do so.

Expected Outcomes of Participation in the Academy

If you participate in more than 75% of the modules offered by the end of the academy you should be able to understand:

• how to develop research purpose statements and research questions;
• the process of conducting research using quantitative and qualitative approaches;
• identify an appropriate research design aligned to your research question;
• be aware of qualitative and qualitative data collection, analysis, and interpretation techniques;
• the importance of conducting research ethically;
• understand the principles of effective communication
• be familiar with the basic functioning of SPSS and STATA
• basic guidelines for undertaking a literature review study and to analyse qualitative data effectively using Atlas.TI

Evaluation of The Academy

Evaluation feedback is important in planning for future Academies sessions. We would like to urge you to please complete the evaluation for each module you have participated in. A link will be provided for each session.

We are looking forward to meeting you at the Academy and wishing you all an enlightening learning experience.

Yours sincerely

On behalf of the Academy Team

HSRC : Dr Bongiwe Mncwango, Ms Shirin Motala, Ms Jaqueline Harvey, Ms Tahiya Moosa, Ms Thandeka Mdletshe, Ms Nondumiso Masuku, Ms Lindiwe Malumbazo, Ms Amanda Phetla and Mr Zwelakhe Maseko

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Clinical Research Associate

• Location: South Africa
• Categories Clinical Monitoring
• __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions
• __vacancyopjusttionswidget.opt-Remote Working __ Remote

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About the role, this vacancy has now expired. please see similar roles below....

Location: South Africa, Home-based

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON South Africa is seeking experienced CRAs to join one of our largest embedded sponsor programs. You will have the support of a local monitoring team as well as a highly tenured Senior Management team who are always supporting internal progression opportunities.

As a Clinical Research Associate (CRA) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. You will be fully integrated into the client's systems, using their SOPs.

• The team is highly structured and functions are very specialized, allowing you to focus solely on producing quality monitoring, building relationships with sites and taking ownership of site management
• There is a strong pipeline of studies and you will have the opportunity to monitor groundbreaking trials and work in a dynamic environment which promotes learning and versatility
• Access to advanced technologies is provided. This streamlines processes allowing you to work more efficiently
• You will be part of a team which has seen huge growth across South Africa across varied therapeutic areas
• You will be joining a well-renowned sponsor program
• There is a strong and passionate ICON leadership team who take a hands on approach and you will be encouraged to participate and share your ideas. The management team are supportive of career development and you will have access to external training opportunities and pathways of development

Responsibilities:

• You will monitor multiple Phase clinical trial sites, across different therapeutic areas. 
• You will utilize your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.
• You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
• You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
• As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.
• Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.
• A minimum of 12 months of independent on-site monitoring experience
• Relevant Bachelor’s Degree (or equivalent) with 3 years of relevant healthcare experience in the pharmaceutical or clinical research industry.
• Strong therapeutic and protocol knowledge as provided in company training.
• Proficiency with medical terminology
• Working knowledge of Local Regulations
• A demonstrated working knowledge of ICH/GCP Guidelines
• Excellent record-keeping skills and attention to detail
• Experience conducting Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
• Fluent in English, both written and oral
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Strong technical skills with CTMS, eCRF, eTMF

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

ICON and you

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Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

Day in the life

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To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce

 Senior CRA Yemi Moses recounts her development and shares her career ambitions with ICON plc.

Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?

Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment.

Suzaita Hipolito

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