RESEARCH GOVERNANCE AND SPONSORSHIP COORDINATOR

Submissions

• Prepare and submit research documents for COMREC, NHSRC, NCST, and PMRA review, ensuring all required documentation is complete and accurate.
• Manage communication with study sponsors, maintaining clear and timely updates.
• Review and submit initial proposals, study protocol amendments, and close-out reports (including final reports) to Ethics Committees and regulatory authorities.
• Act as a proxy for researchers in correspondence with Ethics Committees and regulatory bodies.
• Ensure timely submission of no-fault trial participants’ insurance for NCST endorsement.
• Assist the Research Governance Officers (RGO) with progress reports, safety reports, and deviation report submissions to ethics and regulatory bodies.

Documentation and Clinical Trial Agreement Management

• File all submissions and responses from Ethics Committees and regulatory bodies, as well as monitoring visit reports in the Research Governance (RG) folder.
• Coordinate the maintenance of records related to study monitoring, ethical, regulatory submissions, and clinical trial agreements.
• Document and track the lifecycle of clinical trial agreements, including drafting, execution, amendments, and renewals.
• Follow up on outstanding clinical trial agreements, liaising with sponsors, investigators, and legal teams to ensure timely completion and compliance.
• Review study contracts and facilitate their processing as required.
• Work with CRSU Managers to address inspection findings and sponsorship review comments, coordinating remedial actions and ensuring completion of tasks.
• Support CRSU Governance and Quality Managers in the development and maintenance of research governance documentation, templates, and standard operating procedures.
• Produce monthly work plans and reports on sponsorship, and clinical trial agreement activities.

Research Project Management

• Disseminate and promote best practices through advice and guidance on research governance, including induction of new staff and Principal Investigators.
• Provide training for MLW staff on research governance and clinical trial agreement procedures.
• Monitor compliance of MLW research studies with ethical, sponsor, and contractual requirements.
• Conduct internal audits of MLW departments and field sites to ensure adherence to approved study protocols and agreement terms.
• Support researchers in closing out research projects and ensuring proper documentation and archiving all agreements and study records.

General Responsibilities

• Represent the Clinical Research Support Unit Managers as required.
• Establish and maintain effective communication and working relationships internally and externally (e.g., with the Blantyre District Health Office and other collaborators).
• Communicate effectively with investigators, collaborators, and key stakeholders involved in study implementation.