Sr. Clinical Research Associate

2 weeks ago

Durban, South Africa Afrique Connection Consultancy Full time

This is a full-time, on-site role for a Clinical Research Associate based in Durban. The Clinical Research Associate will oversee the daily operations of clinical trials, ensure compliance with protocols, and manage research activities. Responsibilities include coordinating with clinical trial sites, monitoring the progress of studies, and maintaining accurate documentation. The role involves close collaboration with other clinical research professionals to ensure the integrity and quality of the research data.

**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.

**Qualifications**
- A bachelor’s degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent).
- At least 2-3 years of 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.
- Prior 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.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and familiarity with electronic data capture (EDC) systems.
- Experience working within a multidisciplinary research environment is an advantage.

**Job Type**: Permanent

Work Location: In person

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