Regulatory Compliance Officer (Fixed Term Contract - Wits RHI)

SUMMARY:
Background:

• The Wits Reproductive Health and HIV Institute (Wits RHI) is a renowned African-led research institute that seeks solutions to Africa’s health challenges
• It is located within the University of the Witwatersrand and addresses some of the greatest public health concerns affecting our region, including HIV and its related problems, sexual and reproductive health, and vaccinology

POSITION INFO:
Main purpose of the job: To monitor and ensure compliance with regulatory and good clinical research practice requirements within research studies Location: Gauteng Key performance areas: Maintain regulatory systems for Wits RHI implementation science projects per SAHPRA, WHREC, WHO ERC Sponsor and DOH requirements Support in drafting submissions of technical reports to IRB's, SAHPRA and Sponsors as needed Initial submissions for studies: Ethics, SAHPRA preparation, submissions, communication and follow up Recruitment approvals: Research District, Clinic Managers submissions and approvals on the NHRD Amendments: ethics, SAHPRA preparation, submissions, communication, follow up and update tracking log Annual recertification: Ethics, preparations, submissions and follow up Six-monthly progress reports: Ethics, SAHPRA, track all events for the last six months (bi- weekly reports for studies for public health outbreaks) Safety updates: Ethics and SAHPRA line listings. submissions and update tracking log Retain current research staff CVs, GCP, MPS, HPCSA, SAPC, SANC certificates Informed consent review, participate in monitoring visits, internal (Sponsor) and external regulatory inspections Review systems and recommend improvements to streamline the creation and maintenance of trial documentation i.e. project management Provide guidance on the requirements of local and international regulatory bodies and frameworks, and support the department to comply with those requirements Review and ensure that the study has all essential regulatory documentation Assist Sponsors \/ monitors before, during and after monitoring visits Study insurance- renewals, liaising with Sponsor regarding approval of insurance funds Take ownership and accountability for tasks and demonstrates effective self management Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained Take ownership for driving own career development by participating in ongoing training and development activities such as conferences, workshops etc Required minimum education and training: 3 year Diploma or Degree in a Health related field Required minimum work experience: Minimum 3 years relevant work experience within a Clinical Research environment (if possible in the Regulatory Compliance Department) Desirable additional education, work experience and personal abilities: Understanding of the research language, detailed knowledge and understanding of the relevant studies and SOP's, knowledge of clinical research documentation Maintain a positive attitude and respond openly to feedback Detailed knowledge of regulatory application and approval processes Computer literate with ability to create or work with databases\/Excel logs Fluent in English, fluency in one of the other official SA languages particularly Setswana, Zulu or Sesotho would be an added advantage Good written and verbal communication skills Strategic thinking and problem-solving skills Conscientious and precise delivery of work even when under pressure Effective self management, resourcefulness and initiative to solve problems Excellent communication and presentation skills 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 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: 15 September 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