IDI
General Summary
Background:
The Infectious Diseases Institute (IDI) at Makerere University has been awarded a grant from the European and Developing Countries Clinical Trials Partnership (EDCTP) to carry out a large-scale trial of secondary TB preventive therapy. The Recurrent TB Screening and Prevention Study (RECENT TB study) is a randomized controlled trial which will be carried out in Uganda and South Africa from September 1, 2026, to August 31, 2030. The study will examine the effectiveness of secondary TPT for preventing recurrent TB while also evaluating the implementation considerations for the successful implementation of secondary TPT in public health settings and the potential of biomarkers to identify patients at the highest risk of recurrence.
To support the successful implementation of this trial, IDI is seeking a highly motivated individual to serve as a study coordinator while simultaneously pursuing a PhD. This dual role offers a unique opportunity to contribute to cutting-edge clinical research while developing advanced research skills at the doctoral level.
Job Purpose:
The Study Coordinator will be responsible for the day-to-day coordination of the trial. S/he will work closely with the Scientific Lead and the broader study team to ensure high-quality, protocol-compliant study implementation. Concurrently, s/he will be enrolled in a doctoral program, using the trial data and research experience to develop and complete a PhD thesis within the contract period.
Key Responsibilities
Study Coordination and Trial Management
- Oversee participant recruitment, randomization, and follow-up schedules in accordance with the approved protocol, Good Clinical Practice (GCP) guidelines, and EDCTP regulations
- Ensure timely and accurate collection, entry, and verification of study data using electronic data capture systems.
- Oversee training and coordination of study nurses, health facility staff, and community health workers in both Uganda and South Africa to ensure smooth trial operations. Occasional travel to South Africa may be needed for this.
- Maintain up-to-date versions of all study documentation, including study protocol, informed consent forms, and data collection tools.
- Assist in the preparation of study reports, safety reports, and interim analyses for the Data Safety Monitoring Board (DSMB) and EDCTP.
- Liaise with the IDI Research and Ethics Committee and the Uganda National Council for Science and Technology (UNCST) to ensure ongoing compliance.
- Coordinate and support monitoring visits, audits, and inspections by the IDI monitoring unit, EDCTP, and other regulatory authorities.
- Participate in study team meetings, investigator meetings, and relevant scientific conferences.
PhD Research Activities
- Develop a PhD concept and enroll in an approved PhD program at Makerere University and/or the University of Amsterdam by the end of Year 1.
- Develop a full doctoral research proposal in consultation with the RECENT TB Scientific and Capacity Building Leads as well as academic supervisors and achieve full registration by the end of Year 2.
- Prepare and submit at least 2 manuscripts for peer-reviewed publication in accordance with PhD requirements by the end of Year 4.
- Present research findings at national and international scientific conferences.
- Engage with the PhD supervisory committee and attend required academic modules and seminars.
- Supervise at least one master’s-level student by the end of Year 4.
- Submission of PhD thesis for final viva voce examination by the end of Year 4
Reporting and Supervision
- For trial-related outputs, the study coordinator will report directly to the scientific lead—RECENT TB. Regular performance reviews will be conducted by the Scientific Lead in alignment with IDI’s performance management framework. For academic purposes, s/he will report to the RECENT TB Capacity Building Lead as well as her designated PhD supervisory committee in accordance with the requirements of Makerere University and/or the Graduate School of the Amsterdam University Medical Center.
Academic Qualifications
- Bachelor’s degree in medicine and surgery (MBChB), plus a Master’s degree in Public Health, Epidemiology, Clinical Research or Internal Medicine
- Minimum of 5 years of experience working in clinical research or public health in the Ugandan setting, preferably in TB, HIV, or other infectious diseases.
- Demonstrable interest in research, scientific writing and publication with at least one first author peer reviewed publication
Person Specification
- Experience with electronic data capture tools and statistical software (RedCap, STATA, R)
- Training in Human Subjects Research (HSP) and Good Clinical Practice (GCP)
- Strong interpersonal skills and cultural sensitivity for working with TB affected communities
