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: Bachelors Degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent) 23 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