Monitoring and Regulatory Officer

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

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