Clinical Trial Investigator and Ctu/crs Coordinator

1 week ago

Stellenbosch, South Africa Stellenbosch University Full time

Duties/Pligte
**Clinical trial Investigator**
- Leading or co-leading implementation of clinical trials primarily focused on TB prevention and treatment including PHOENIx and TBTC study 37;
- Coordinating the start-up of clinical trials, including liaising with stakeholders, coordinating regulatory submissions, developing source documentation and systems at site level;
- Overseeing trial implementation and compliance with sponsor requirements;
- Maintaining participant related clinical documentation and query resolution;
- Supporting training of personnel.

**NIH CTU and CRS coordinator**
- Working across the DTTC and other clinical research sites at the NIH-funded Stellenbosch Clinical Trials Unit (CTU) including FAMCRU to:

- Coordinate joint CTU activities including Bi-monthly SUN-CTU meetings, and reporting and liaising with the NIH;
- Coordinate responses to relevant sponsor-led requests and communications;
- Coordinate the annual SUN-CTU Progress Report compilation and submission;
- Attend network meetings as required;
- Coordinate quality assurance activities - supporting the coordination of the QA activities of the DTTC Quality Management team. The CRS coordinator will work with the QAMs to coordinate/review these activities;
- Support regulatory activities -The CRS coordinator plays a pivotal role in communicating with sponsors and regulatory bodies: HREC, SAHPRA, NHREC, the Western Cape Government and City of Cape Town Health Services. These activities are delegated to the QAM.

Job Requirements/Pos Vereistes
- MBChB qualification;
- Current active HPCSA registration;
- Fluent in English;
- Excellent communication skills;
- At least five years' experience of TB therapeutic trials as investigator/coordinator;
- Experience in working with IMPAACT, ACTG, TBTC or other US federal trial networks;
- Experience in leading the start-up and implementation of TB trials at South African sites;
- Experience with HREC, SAHPRA, NHREC, COCT, WCG, and DAIDS regulatory submissions.

Recommendation/Aanbeveling
- Experience in pursuing postgraduate training and contribution to academic outputs;
- CGP, HSP training completed and active.

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