Are you passionate about advancing healthcare through groundbreaking research? If so, the Desmond Tutu TB Centre (DTTC) at Stellenbosch University has an incredible opportunity for you. The Centre is seeking a dynamic and experienced Study Coordinator (Job Level 8) to join their multidisciplinary team. This position is based in Kuils River and involves coordinating international clinical trials focusing on TB and HIV treatment and prevention. This is a two-year contract position, with an option to extend based on funding availability.
Study Coordinator Job Overview
- Position: Study Coordinator
- Reference: TGB12/329/1224
- Location: Kuils River, South Africa
- Department: Faculty of Medicine and Health Sciences – Department of Paediatrics and Child Health
Study Coordinator Job Description
This role is instrumental in ensuring the smooth operation and protocol compliance of TB trial activities at both site and institutional levels. You will work closely with the clinical and regulatory teams, quality managers, and other essential personnel to oversee all aspects of clinical trial coordination.
Key Responsibilities
1. Administrative Duties
- Act as the main liaison between sponsors, investigators, and regulatory authorities.
- Organize and participate in meetings, including taking and sharing minutes.
- Coordinate study-specific and general training for staff.
- Archive study materials after project completion.
- Ensure smooth site activation and operational delivery.
2. Regulatory Management
- Prepare and submit documents to relevant ethics committees and regulatory bodies, including SAHPRA and DOH.
- Maintain compliance with ethics, regulatory guidelines, and SOPs.
- Submit safety reports, protocol deviations, and other necessary documentation.
3. Quality Assurance & Control
- Implement and monitor quality control and assurance processes.
- Ensure adherence to trial and site requirements, including Good Clinical Practice (GCP).
4. Study Start-Up & Clinical Operations
- Gain in-depth knowledge of trial protocols and amendments.
- Manage recruitment goals, enrolment targets, and retention strategies.
- Develop and maintain study documentation, such as case report forms (CRFs).
- Train staff and implement study-specific procedures.
5. Network & Grant Coordination
- Ensure timely submission of network-required documents.
- Coordinate with site research personnel and external stakeholders.
6. Financial Oversight
- Assist in verifying monthly billing for trial visits.
- Provide financial feedback to the Principal Investigator (PI).
Essential Requirements
Candidates must meet the following minimum qualifications and experience to be considered:
- Education: Registered nurse with active SANC registration.
- Experience:
- At least 3 years in TB therapeutic trials with investigational products.
- Proven experience coordinating randomized clinical trials for TB, HIV, or infectious diseases.
- Expertise in quality control, quality assurance, and regulatory compliance.
- Skills:
- Strong knowledge of clinical trial regulations, GCP, and auditing processes.
- Proficiency in Microsoft Office (Word, PowerPoint, Excel, Teams).
- Sound interpersonal and organizational skills.
- Excellent verbal and written communication in English.
- Other: Valid driver’s license and access to transport.
Desirable Skills and Experience
- Knowledge of national and international clinical trial regulations.
- Experience in pharmaceutical-sponsored trials.
- Multilingual abilities in Afrikaans, isiXhosa, or isiZulu.
Why Join the Desmond Tutu TB Centre?
By joining the DTTC, you’ll play a pivotal role in advancing healthcare for communities impacted by TB and HIV. The Centre is a leader in research innovation, committed to fostering a collaborative, inclusive, and high-performing environment.
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How to Apply
To apply, please submit a comprehensive CV (including the names and email addresses of at least three referees) via the official Stellenbosch University career portal:
Ensure your application is submitted before the closing date: 15 January 2025.
For additional information, contact:
- Sterna Brand at 021 938 9755 or slbrand@sun.ac.za
- For technical support: Human Resources Client Services at sun-e-hr@sun.ac.za
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Additional Information
- Commencement Date: 1 February 2025
- Stellenbosch University is committed to employment equity and reserves the right not to make an appointment.
- Background checks and qualification verification will be conducted.
The Study Coordinator position at the Desmond Tutu TB Centre (DTTC) offers a unique opportunity to contribute to impactful research aimed at combating TB and HIV, diseases that continue to challenge global health. With a focus on innovation, compliance, and collaboration, this role is ideal for a passionate and experienced professional ready to make a difference in the lives of patients and communities.