Research Study Coordinator (Clinical trials)

The organisation's goal is to undertake globally relevant and locally responsive research that advances understanding in the areas of HIV vaccines and pathogenesis, prevention and epidemiology, as well as the relationship between tuberculosis and AIDS treatment, and Covid 19. It serves as an international collaborating centre for HIV research and policy, is recognised as a national Centre of Excellence in HIV prevention, and hosts a major research unit focused on HIV TB pathogenesis and treatment.

The successful individual will be responsible for coordinating and directing the project activities of phase I and II (1 & 2) clinical trials at our eThekwini Clinical Research Site.

• Bachelor's Degree in a Health related field.
• Honours, Master's or PhD degree in Public Health or Basic/Clinical Science would be advantageous.
• At least 3 years' experience in a similar role within a research environment.
• Clinical trial experience (worked on or managed at least one clinical trial in similar role).
• Experience with Protocol writing, preparation of all required documentation for clinical trial implementation (e.g. SOP's CRF's, LRF's) and report writing.
• Previous experience with SAHPRA, BREC and other regulatory submissions.
• Sound knowledge of HIV/AIDS and/or TB research.
• Understanding of Good Clinical Practices and clinical trial site processes is essential.
• Experience in leadership and people management.
• Strong research focus and a publication record is advantageous.

• Attention to detail with strong analytical ability
• Excellent ability to build interpersonal relationships and partnerships
• Strong problem solving and decision making abilities
• Excellent scientific writing and communication skills (English written and verbal)
• Ability to organise and manage multiple priorities
• Ability to work independently, and fit in well within a multi disciplinary team

• Study administration, including day to day management of study related activities, people management, compilation and analysis of reports and liaison with all key study stakeholders.
• Conduct or arrange relevant study related training for staff.
• Prepare and submit regulatory submissions and follow up on responses and approvals with regulatory agencies.
• Oversight of Quality Control of all study related source documents.
• Attend international/national conference calls, study meetings, funder and stakeholder engagement.
• Compilation and submit study progress reports and all other study related documentation.
• Maintain and update the Investigator Site File.