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Clinical Research Associate - Johannesburg

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.

• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.

• Collaborating with investigators and site staff to facilitate smooth study conduct.

• Performing data review and resolution of queries to maintain high-quality clinical data.

• Contributing to the preparation and review of study documentation, including protocols and clinical study reports

Your profile

• Bachelor's degree in a scientific or healthcare-related field.

• Minimum of 2 years of experience as a Clinical Research Associate.

• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.

• Strong organizational and communication skills, with attention to detail.

• Ability to work independently and collaboratively in a fast-paced environment.

• Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our

careers site

to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Job Title: Clinical Research Associate (CRA)

Location: Cape Town, South Africa

Company: ICON Strategic Solutions – FSP

As a Clinical Research Associate, Your Primary Focus Will Be On The End-to-end Management Of Clinical Trials At Assigned Study Sites. You Will

• Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
• Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
• Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
• Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
• Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
• Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
• Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.

We're Searching For a Highly Motivated Individual With

• A minimum of 3 years of experience as a CRA or in a similar role, preferably across multiple therapeutic areas.CV and Respiratory are an advantage.
• University degree in Health Science, or a related field.
• To be based in Cape Town.
• Compliance Knowledge: Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
• Communication Skills: Excellent interpersonal and communication skills, with the ability to build strong relationships with investigators and site staff.
• Problem-Solving: A proactive approach to identifying and resolving issues while maintaining a high level of attention to detail.
• Adaptability: The ability to work effectively in a fast-paced and dynamic environment, managing multiple priorities with precision.

What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON:

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Clinical Research Associate - Johannesburg

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What You Will Be Doing

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports

Your profile

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organizational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license

What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

CAPRISA is an award-winning global research organisation located on the campus of the Nelson R Mandela School of Medicine in Durban, South Africa and undertakes research in HIV, TB and Covid at four clinical research sites in KwaZulu-Natal. CAPRISA's goal is to undertake globally relevant and locally responsive research that contributes to understanding HIV Vaccines and Pathogenesis, Prevention and Epidemiology, the links between Tuberculosis and AIDS treatment and Covid-19. CAPRISA is a UNAIDS Collaborating Centre for HIV Research and Policy and is recognised as a DSI-NRF Centre of Excellence in HIV Prevention and hosts the SAMRC HIV-TB Pathogenesis and Treatment Research Unit.

The successful incumbent will join the CAPRISA Gates Foundation Vaginal Microbiome Clinical Trials Unit (VM-CTU) and will be based at the CAPRISA Headquarters in Durban.

• A bachelor's degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent).
• At least 2–3 years of experience monitoring clinical trials with knowledge of clinical trials operations, preferably early-phase (Phase I/II) studies.
• Solid knowledge of SA GCP guidelines, ICH-GCP guidelines, South African Ethics in Health Research Guidelines, SAHPRA and international regulatory requirements.
• Prior experience in monitoring and/or trial coordination, within an academic or as a CRA in industry-sponsored trial setting.
• Strong understanding of investigational product accountability, safety reporting, and protocol compliance.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and familiarity with electronic data capture (EDC) systems.
• Experience working within a multidisciplinary research environment is an advantage.

• Assume the role of regional monitor for all trials conducted in the VM-CTU for an estimated 5 trials per annum.
• Develop and maintain Standard Operating Procedures relevant to the portfolio.
• Create trial monitoring plans in conjunction with the trial sponsor representatives.
• Conduct study initiation visits for each new trial protocol to assess site readiness for study activation.
• Conduct trial monitoring (clinic, laboratory and pharmacy) to ensure compliance with study protocols, SOPs, ICH-GCP, and local regulatory requirements.
• Review case report forms (CRFs), source documents, and data entry to verify accuracy, completeness, and timeliness.
• Monitor and track protocol deviations, adverse events (AEs/SAEs), and data queries.
• Review essential study documentation, including trial master file (eTMF) and investigator site file (eISF).
• Prepare monitoring reports, progress updates, and assist with audits and inspection preparation.
• Contribute to quality assurance initiatives and continuous improvement of trial conduct at the unit.
• Support close-out activities, ensuring data integrity and regulatory compliance are maintained throughout the trial lifecycle.

Role Description

This is a full-time, on-site role for a Clinical Research Associate based in Durban. The Clinical Research Associate will oversee the daily operations of clinical trials, ensure compliance with protocols, and manage research activities. Responsibilities include coordinating with clinical trial sites, monitoring the progress of studies, and maintaining accurate documentation. The role involves close collaboration with other clinical research professionals to ensure the integrity and quality of the research data.

Responsibilities:

• Assume the role of regional monitor for all trials conducted in the VM-CTU for an estimated 5 trials per annum.
• Develop and maintain Standard Operating Procedures relevant to the portfolio.
• Create trial monitoring plans in conjunction with the trial sponsor representatives.
• Conduct study initiation visits for each new trial protocol to assess site readiness for study activation.
• Conduct trial monitoring (clinic, laboratory and pharmacy) to ensure compliance with study protocols, SOPs, ICH-GCP, and local regulatory requirements.
• Review case report forms (CRFs), source documents, and data entry to verify accuracy, completeness, and timeliness.

Qualifications

• A bachelor's degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent).
• At least 2–3 years of experience monitoring clinical trials with knowledge of clinical trials operations, preferably early-phase (Phase I/II) studies.
• Solid knowledge of SA GCP guidelines, ICH-GCP guidelines, South African Ethics in Health Research Guidelines, SAHPRA and international regulatory requirements.
• Prior experience in monitoring and/or trial coordination, within an academic or as a CRA in industry-sponsored trial setting.
• Strong understanding of investigational product accountability, safety reporting, and protocol compliance.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and familiarity with electronic data capture (EDC) systems.
• Experience working within a multidisciplinary research environment is an advantage.

This is a full-time, on-site role for a Clinical Research Associate based in Durban. The Clinical Research Associate will oversee the daily operations of clinical trials, ensure compliance with protocols, and manage research activities. Responsibilities include coordinating with clinical trial sites, monitoring the progress of studies, and maintaining accurate documentation. The role involves close collaboration with other clinical research professionals to ensure the integrity and quality of the research data.

Responsibilities:

• Assume the role of regional monitor for all trials conducted in the VM-CTU for an estimated 5 trials per annum.
• Develop and maintain Standard Operating Procedures relevant to the portfolio.
• Create trial monitoring plans in conjunction with the trial sponsor representatives.
• Conduct study initiation visits for each new trial protocol to assess site readiness for study activation.
• Conduct trial monitoring (clinic, laboratory and pharmacy) to ensure compliance with study protocols, SOPs, ICH-GCP, and local regulatory requirements.
• Review case report forms (CRFs), source documents, and data entry to verify accuracy, completeness, and timeliness.

Qualifications

• A bachelor's degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent).
• At least 2–3 years of experience monitoring clinical trials with knowledge of clinical trials operations, preferably early-phase (Phase I/II) studies.
• Solid knowledge of SA GCP guidelines, ICH-GCP guidelines, South African Ethics in Health Research Guidelines, SAHPRA and international regulatory requirements.
• Prior experience in monitoring and/or trial coordination, within an academic or as a CRA in industry-sponsored trial setting.
• Strong understanding of investigational product accountability, safety reporting, and protocol compliance.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and familiarity with electronic data capture (EDC) systems.
• Experience working within a multidisciplinary research environment is an advantage.

Job Type: Permanent

Work Location: In person

• Certificate / Degree / Diploma in General Nursing or Clinical Technology or another medical field
• 2 - 5 years experience in clinical research on multiple projects
• Good Clinical Practice Certification (advantageous)
• Keen interest in Research (particularly Allergy, Immunology and Dermatology)
• Computer Literacy (proficiency in Microsoft Office and electronic Data Management systems, email, internet)
• Valid Drivers License (essential)
• Fluency in English and a second language (Afrikaans and / or isiXhosa)
• Good interpersonal, communication and time management skills
• Excellent organisational skills

• Screen participants for inclusion into studies using specified inclusion criteria
• Scheduling of participants for clinical examination and follow up (telephone and community visits)
• Perform all delegated study procedures, i.e. vital signs, electrocardiographys (ECGs), collect laboratory and pharmacokinetic (PK) biological specimens
• Prepare laboratory specimens for shipping or transporting to laboratory
• Management of participant records: maintain, retrieve and file according to study visits. This includes laboratory and procedure results
• Maintain applicable study logs (screening, enrolment, participant confidential identification log, AE tracking, etc.)
• Oversee all trial related activities for sites at both UCT Lung institute and Tertiary Cape hospitals where the unit operations
• Management / Co-ordination of study participants
• Interface with non-study routine clinical and nursing staff in hospitals
• Assist in drafting and updating of SOPs
• Study-related data capture and management
• Perform phlebotomy procedures and insertion of peripheral IV lines (if a nursing applicant)

• Position will be based in Mowbray
• Contract Based
• Working hours: 40 hours per week, Monday to Friday.