Job Description

Closing Date 2025/10/10
Reference Number CAP250925-1
Job Title Protocol Development Specialist
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

• Master's degree in Science, Medicine, Immunology, Microbiology, Public Health or associated allied health professions. PhD would be advantageous.
• Previous clinical trial experience.
• Experience with clinical trial protocol and case report form development.
• Experience with producing annual Drug Safety Update Reports for SAHPRA.
• Experience with Clinical study report writing.
• Strong medical writing skills.
• Publication track record in quality peer reviewed journals.
• ICH (R3) and SA GCP certification.
• Computer literate and advanced skills with MS Office and MS Project.

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

• Develop and maintain Standard Operating Procedures relevant to the portfolio.
• Develop protocol templates for early phase clinical studies, Phase I trials, Phase I first in Human studies to Phase III trials.
• Develop standardized VM-CTU case report forms in conjunction with the trial data manager, statisticians, clinical, laboratory investigators and behavioural scientists (where applicable).
• Work with Principal Investigators, Regulatory Manager, trial study coordinators and science support leads to obtain necessary information to complete trial protocols in advance of regulatory and funder submission dates.
• Lead protocol writing meetings with the VM-CTU Principal investigator, individual Trial PIs and others as needed.
• Manage the rapid update of protocols where needed and work with the regulatory manager to create and distribute letters of amendment and clarification memos.
• Update the Investigators Brochure (for all investigational products) routinely as new data becomes available with the sponsor and ensure coordination with regulatory manager.
• At the end of the trial draft the Clinical Study Report and work with the statisticians, investigators and data management to finalize.
• Support the trial Principal Investigators with medical writing and presentation preparation.

Skills Required