Monitoring and Regulatory Officer NGO Jobs – Infectious Diseases Institute (IDI) | Apply Now

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.