Research Monitor (Clinical Research)

About the role

Woodlands Health is looking for a motivated, detail-oriented Research Monitor to join its Office of Research Development and Scholarships. As the institutional Research Monitor, you will help ensure that clinical research studies are conducted to the highest standards of compliance, quality and patient safety.

Key responsibilities

• Lead risk-based monitoring across the portfolio of clinical research studies, ensuring adherence to protocols, regulatory requirements and Good Clinical Practice (GCP)
• Conduct routine monitoring visits from site initiation to close-out, including source data verification, protection of participant rights and welfare, and traceability of investigational products
• Write monitoring reports, issue follow-up actions and develop CAPA plans for non-compliances, and create educational materials and workshops to build monitoring capability
• Provide regulatory advice and manage submissions such as Clinical Trials Authorisation (CTA), Clinical Trials Notification (CTN) and Clinical Trials Certificate (CTC)
• Prepare study teams for external regulatory inspections and sponsor audits
• Train researchers on ethical guidelines, institutional policies and regulatory requirements, and advise management on regulatory changes

Required profile

• Minimum bachelor's degree, preferably in Life Sciences
• 2 to 5 years of experience in clinical research monitoring (e.g. as a CRA), regulatory compliance or quality assurance
• Experience in a healthcare setting is an advantage; senior coordinators with audit and inspection experience are welcome
• Strong communication, teamwork and ability to thrive in a dynamic environment

Required skills

• Working knowledge of ICH-GCP guidelines and local regulations
• Clinical research monitoring and regulatory compliance