About the position
Background:
- Wits Health Consortium (Pty) Limited ("WHC") is a wholly-owned Company of the University of the Witwatersrand, Johannesburg (South Africa) under its Faculty of Health Sciences
- WHC provides Faculty with a legal framework within which to operate the research and other activities necessary to support its academic objectives
- In addition, WHC offers a range of products and services to Academics
- The Mycology Division aims to improve the outcomes of people affected by serious, life- threatening fungal diseases in South Africa and the African region through public health-focused epidemiological, clinical and basic science research and innovation. Our work also stretches to other important infectious diseases
Division: Wits Mycology
Main purpose of the job:
- This is a clinically active role with significant responsibility for the day-to-day execution of clinical trial protocols, participant safety, regulatory compliance, and site management
- The incumbent will operate under the supervision of the site Principal Investigator(s), manage the study site team (2 Nurses per site) and will work in close collaboration with the wider COMBAT Candida study management group
- The post-holder will be expected to demonstrate strong site management skills, robust clinical trial experience, and the capacity to function independently
- You will also be expected to contribute to the data analysis and any peer-reviewed publications arising from the study, and to contribute to related sub-studies or projects
Location:
- Wits Donald Gordon Medical Centre & Helen Joseph Hospital (main sites) with occasional cross-cover of other sites in Johannesburg
Key performance areas:
- Lead and manage study site research
- Take primary accountability for the correct and timely execution of the COMBAT Candida protocols at the study sites, ensuring all study activities comply with ICH-GCP, applicable SOPs and WPDs, and regulatory requirements
- Actively manage and undertake recruitment of eligible patients according to protocol requirements
- Compile source notes and recruitment tools
- Report Adverse Events (AEs) and Serious Adverse Events (SAEs) promptly and manage follow-up to resolution in compliance with sponsor and regulatory requirements
- Contribute to the development of study documentation including protocols, patient information sheets and consent forms, SOPs/ WPDs, quality assurance and quality control guidelines and training manuals
- Manage day-to-day operational running of active clinical trial sites independently, including scheduling, workflow coordination and resource allocation
- Supervise site clinical and nursing teams to ensure adherence to SOPs/ WPDs, protocol requirements, and quality standards
- Ensure all regulatory documentation (site files, ethics approvals, regulatory submissions) is current and audit-ready
- Conduct medical evaluations, review clinical histories, assess eligibility, and ensure appropriate referral pathways are in place for participants requiring additional care
- Uphold the ethical conduct of the study; maintain strict confidentiality of all participant information in accordance with POPIA and applicable data protection frameworks
- Manage data at a site level - meticulously maintain source documentation, complete CRFs proactively identify and resolve protocol deviations, data queries, and missing data in coordination with the Study and Data Management Group
- Prepare for and facilitate external and internal monitoring visits; address queries and CAPAs raised by sponsor monitors or auditors
- Participate in the preparation and review of study reports, abstracts, and peer-reviewed manuscripts arising from the COMBAT Candida study
- Engage with sub-study or ancillary research projects linked to the main cohort as directed by the Clinical Lead or Chief Investigators
- Identify training needs within the site team and coordinate training delivery in liaison with the Trial Management Team e.g. CRF completion training, quality assurance and other study related training
- Familiarity with SAHPRA regulatory framework and ethics submission processes
Required minimum education and training:
- MBBCh/MBChB degree
- HPCSA Registration as an independent medical practitioner
- Certification in good clinical practice (GCP)
Required minimum work experience:
- Minimum 2-year’s work experience as a Medical Officer
- Proven track record of working in a clinical trial research environment and prior sub-investigator experience on a clinical trial
- Experience with electronic data capture (EDC) systems, preferably REDCap
Desirable additional education, work experience and personal abilities:
- Experience in infectious disease, mycology, or related speciality
- Strong scientific writing ability and publication record
- Self-motivated, proactive, and able to work independently under pressure
- Able to exercise discretion and independent decision-making
- Ability to prioritize own workload, take initiative (pro-active) and work to tight deadlines
- Work as part of the multidisciplinary team to ensure good patient care and good quality data
TO APPLY:
- Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV and a cover letter (maximum one page) that clearly states which vacancy you are applying for with 3 contactable references and copy of HPCSA Registration and GCP Certificate
- 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 above criteria will not be considered for the respective position
- Wits Health Consortium will only respond to shortlisted candidates
- Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful
- Closing date: 09 October 2026
- Note: No CV will be accepted after the closing date
Please note:
- WHC, in accordance with its Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto
- AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium
- AJ Personnel does not have any salary or other information regarding the position
Desired Skills:
- GCP
- HPCSA
- Mycology
- Medical Officer
- Research
- Doctor
- MBCHB
