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:
- Assume the role of regional monitor for all trials conducted in the VM-CTU for an estimated 5 trials per annum
- Develop and maintain Standard Operating Procedures relevant to the portfolio
- Create trial monitoring plans in conjunction with the Trial Sponsor Representatives
- Conduct study initiation visits for each new trial protocol to assess site readiness for study activation
- Conduct trial monitoring (clinic, laboratory and pharmacy) to ensure compliance with study protocols, SOPs, ICH-GCP, and local regulatory requirements
- Review case report forms (CRFs), source documents, and data entry to verify accuracy, completeness, and timeliness
- Monitor and track protocol deviations, adverse events (AEs/SAEs), and data queries
- Review essential study documentation, including trial master file (eTMF) and investigator site file (eISF).
- Prepare monitoring reports, progress updates, and assist with audits and inspection preparation
- Contribute to quality assurance initiatives and continuous improvement of trial conduct at the unit
- Support close-out activities, ensuring data integrity and regulatory compliance are maintained throughout the trial lifecycle
Minimum Requirements:
- Bachelor’s Degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent)
- 2–3 years’ experience monitoring clinical trials with knowledge of clinical trials operations, preferably early-phase (Phase I/II) studies
- Solid knowledge of SA GCP guidelines, ICH-GCP guidelines, South African Ethics in Health Research Guidelines, SAHPRA and international regulatory requirements
- experience in monitoring and/or trial coordination, within an academic or as a CRA in industry-sponsored trial setting
- Strong understanding of investigational product accountability, safety reporting, and protocol compliance
- Proficient in Word, Excel, PowerPoint, Outlook and familiar with electronic data capture (EDC) systems
- Experience working within a multidisciplinary research environment is advantageous
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:
- Bachelor’s Degree
- GCP
- SAHPRA
- Clinical Research Associate
- Pharmacy
- Nursing
- Durban
