About the position
Background:
- Our client is an award-winning global clinical research organisation in the Durban area.
- They undertake research in HIV, TB and Covid
Contract Period: 2 year Fixed Term Contract - Renewable
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 & 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 & 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 each trial, draft the Clinical Study Report & work with the Statisticians, Investigators and Data Management to finalize
- Support the trial Principal Investigators with medical writing and presentation preparation
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 & medical writing
- Publication track record in quality peer reviewed journals
- ICH (R3) and SA GCP Certification
- Proficient on MS Office and MS Project
TO APPLY:
- Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
- 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 minimum requirements will not be considered for the respective position
- Note our clients may expire jobs at their own discretion
- AJ PERSONNEL will only respond to shortlisted candidates
- If you have not received a response within two (2) weeks from applying, your application was then unsuccessful for that specific position, however your profile remains on our system for future opportunities
- Closing Date: 10 October 2025
- Note: No CV will be accepted after the closing date
Desired Skills:
- ICH (R3)
- GCP Certification
- Protocol Development Specialist
- Master's Degree
- Durban
- Immunology
- Healthcare
