Job Description

Closing Date 2025/10/10
Reference Number CAP250925-2
Job Title Clinical Research Associate
Site CAPRISA Head Office (DDMRI)
Job Type Classification 2 Year Fixed Term Contract - renewable
Location - Town / City Durban
Location - Province KwaZulu-Natal
Location - Country South Africa

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.
Minimum Requirements

• 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.

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

• 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.

Skills Required