Clinical Research Associate - (Healthcare - 2 year FTC - Renewable)

SUMMARY:
Background:

• Our client is an award-winning global clinical research organisation in the Durban area
• They undertake research in HIV, TB and Covid

POSITION INFO:
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

• 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

• Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
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• Closing Date: 10 October 2025
• Note: No CV will be accepted after the closing date