188 Clinical Research Associate jobs in South Africa

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

Sr Clinical Research Associate - Oncology/Haematology Experience

Sponsor Dedicated

Johannesburg based

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications and Experience
• Bachelor's Degree Degree in scientific discipline or health care.

• Requires at least 3 years of on-site monitoring experience.

• Experience in Oncology/Haemotology required.

Knowledge and Skills

• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at

• 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

• Bachelors Degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent)
• 23 years 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
• 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
• Proficient in Word, Excel, PowerPoint, Outlook and familiar with electronic data capture (EDC) systems
• Experience working within a multidisciplinary research environment is advantageous

• Only if you meet the minimum job requirements and experience as mentioned above , you may submit a detailed updated CV
• Please Apply Online and complete your registration via our website to enable and protect you as a candidate and to accept the new POPIA terms and conditions
• This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL
• However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market
• Please take note that the applicants who do not adhere to the minimum requirements will not be considered for the respective position
• Note our clients may expire jobs at their own discretion
• AJ PERSONNEL will only respond to shortlisted candidates
• If you have not received a response within two (2) weeks from applying, your application was then unsuccessful for that specific position, however your profile remains on our system for future opportunities
• Closing Date: 10 October 2025
• Note: No CV will be accepted after the closing date

Sr Clinical Research Associate - Oncology/Haematology Experience

Sponsor Dedicated

Johannesburg based

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications and Experience

• Bachelor's Degree Degree in scientific discipline or health care.

• Requires at least 3 years of on-site monitoring experience.

• Experience in Oncology/Haemotology required.

Knowledge and Skills

• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more

PSI is a leading Contract Research Organization (CRO) with about 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

At PSI, Proposal Manager coordinates all phases of PSI’s proposal process while maintaining the company’s win rate of 30% and higher. You will contribute to everything from RFP strategy to bid defense slide decks. You will partner with global teams of subject matter experts from Feasibility, Medical Affairs, Project Management, Clinical Operations, Budgeting, and Business Development to rapidly produce winning proposals.

This proposal development will include:

• Developing high-quality strategic proposals thatmeet our clients’ needs
• Preparing viable RFP calendars and ensuring RFP milestones are met by all involved individuals in a timely manner
• Organizing, attending, and leading strategy calls for RFPs
• Developing draft budgets in CLARITY
• Contributing to study modeling in VISIONAL
• Reviewing clients’ specifications, obtaining quality feedback from various stakeholders within the company
• Working with the budgeting team to develop competitive final budgets
• Preparing vendor RFPs and obtaining vendor quotes
• Providing support for bid defense meetings

• A minimum of a four-year degree from an accredited college or University
• Experience managing full-service clinical trial proposals at a CRO is a must
• Writing and editing skills
• Analytical skills
• Time management and organization skills
• Flexibility and creativity in responding to potential clients
• Proficiency in Microsoft Word, Excel and PowerPoint

This is a creative tight-knit team of professionals motivated by producing quality proposals that resonate with our customers. Our culture is open, collaborative, and purposeful. We’re now looking for talented people who don’t believe in one-size-fits-all templates and have a passion for writing proposals that get read and remembered.

Minimum Requirements

• Master's degree in science, immunology, medicine, microbiology, public health or associated allied health professions.
• Previous clinical trial conduct experience.
• Previous demonstrable project management experience.
• ICH (R3) and SA GCP certification.
• Computer literate and advanced skills with MS Office and MS Project.
• Previous eTMF or eISF software experience would be advantageous.

Personal Qualities and Competencies

• Strong attention to detail with a commitment to accuracy and data integrity.
• Excellent organizational and time management skills with the ability to manage multiple priorities under tight timelines.
• Effective communication and interpersonal skills to foster collaborative relationships across multidisciplinary teams.
• Ability to work proactively and independently, while also being a strong team player.
• Analytical and problem-solving skills with a practical, solutions-oriented approach.
• High level of integrity, discretion, and professionalism in handling confidential information.
• Adaptability and resilience in a fast-paced, dynamic early-phase research environment.

Key Responsibilities

• Co-ordinate the activities of the VM-CTU in accordance with the unit milestones and timelines.
• Convene routine meetings on behalf of the VM-CTU PI with funders, collaborators, sponsors (where applicable), site clinical trial teams and trial monitors. Including compiling and distribution of meeting summaries and tracking of action items.
• Provide JSC, PSRT, DSMB secretariat support (advance meeting scheduling and meeting summary coordination and distribution).
• Coordinate with the mucosal immunology laboratory, head of laboratory trial statisticians and data management to ensure the secure storage and curation of laboratory and basic science data that are batch processed from local and international laboratories.
• Report writing in accordance with funder requirements.
• Science presentation and medical writing support to the Principal Investigator.

Job Types: Full-time, Permanent

Work Location: In person