Job Title: Monitoring and Regulatory Officer (Fresher NGO Jobs)
Organisation: Infectious Diseases Institute (IDI)
Duty Station: Mulago, Kampala, Uganda
Reports to: Senior Research Manager
About the Company:
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 research 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 Duties and 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.
Qualifications, Skills and Experience:
- 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
How to Apply:
All interested candidates should apply online at the link below.
Deadline: 21st August 2024
NB: Applications will be reviewed on a rolling basis until the position is filled. Only shortlisted candidates will be contacted for interviews.
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