(KZN North Suburbs), Temporary Contract -4 months , 2026
Salary: Market-Related, depending on experience.
RESPONSIBILITIES / DUTIES
- Assisting with protocol/project specific regulatory issues, communication and submission, including those made to IRB, SAHPRA, hospital management, DoH, District Health, Municipality.
- Responsible for maintaining the regulatory hard copies in the regulatory binders at all sites
- Responsible to uploading and downloading documents to and from online platforms (such as ShareFile, Florence, Veeva, etc)
- Submission of update/progress reports and publications to DOH, municipality and district officers.
- Assisting with re-certification of all studies
- Assisting with submissions of EAE to IRB and SAHPRA
- Coordination of central regulatory issues including updating of all personnel CVs, licences, network conflict of interest forms, GCP and HSP certifications, IATA certifications, laboratory certifications and normal ranges. All tracking records are to be maintained in hard and soft copy in the central regulatory files.
- Assist with scheduling renewal trainings for staff GCP certificates
- Assist with coordinating renewals of staff insurance certificates
- Preparation for monitor visits
- Liaising with study monitors for site visits
- Participate in all study related conference calls, if applicable
- Attend all training and site initiation visit meetings
- Maintain essential documents file
- Submit approved studies to RSC for protocol registrations
- Ensure regular QA/QC of regulatory files
- Perform any other reasonably expected task within the scope of skillset and capabilities
Desired Experience and Qualifications
-Good Clinical Practice Certificate required
-Strong admin and filing skills required
-Knowledgeable on MS Word, MS Excel (able to create and update spreadsheets)
-Previous Regulatory knowledge highly advantageous.
.-Travel to sites-own vehicle preferable.
-Good verbal communication.
-Ability to learn from observation.
Experience:
- Clinical Research /Regulatory: 1 year (Preferred)
Work Location: In person
