General Summary
Infectious Diseases Institute (IDI) is an independently governed institute within the College of Health Sciences at Makerere University and has the mission “To strengthen health systems in Africa, with a strong emphasis on infectious diseases, through Reseaích and capacity development.” IDI has operations across Uganda as well as in a number of other African countries and has a staffing of over 1,000 managing multiple projects in Research, clinical services, public health and training.
Key Responsibilities
- Liaison with the study PIs and study coordinators, take the lead on all communications and submissions to local and international IRBs and Sponsors.
- Take the lead in planning and conducting training for new and old staff on research regulatory compliance and source documentation (New/ongoing studies) as per national and international guidelines, especially GCP training.
- Work with the different study teams on developing the study-specific consent procedures and S.O. Ps, if applicable, together with the regulatory assistant.
- Assist the Quality Manager in developing the QA/QC plan and work closely with the PIs in developing the site QM plans.
- Take the lead in reviewing the study regulatory files according to Regulatory office schedules.
- Ensure the centralized master files filling system is per GCP guidelines with restricted access to unauthorized personnel
- Ensure the functionality of the Regulatory Affairs System (RAIS), including keeping it updated at all times
- Support the functionality of IDI REC, including organizing or scheduling its meetings
- Monitoring studies' compliance and submitting SAE reports to the US RAC, the local IRB, and other local regulatory bodies.
- Maintain all essential documents across studies according to GCP and Sponsor guidelines, IDI policies, and advice/ guidance from study monitors
- Assist the Study Coordinators and PI during external monitoring/Audit.
- Follow-up on any regulatory pending issues (submission/approvals).
- Responsible for reviewing all participants signed informed consents once delivered to the Regulatory office and maintaining a confidential tracking log for all ICs across studies.
- Responsible for tracking all research regulatory documents, e.g., Staff HSP/GCP training and practicing license.
Academic Qualification
- Degree in any Health-Related Field or Humanities
Person Specification
- Degree in any health-related field or humanities
- A master of bioethics is desirable
- 1-year experience with regulatory and monitoring activities
- Knowledgeable about national and international regulatory and monitoring framework