Clinical Research Monitor

About the role

The Clinical Research Monitor ensures that clinical studies are conducted in compliance with approved protocols, regulatory requirements, and Sidra Medicine’s policies. The role involves quality control of research data, protection of participant rights, and oversight of multiple projects simultaneously.

Key responsibilities

• Monitor study procedures and documentation, including informed consent, source documents, CRFs, adverse events, investigational product handling, and protocol deviations.
• Conduct monitoring visits, prepare detailed reports, and follow up on corrective actions with the principal investigator.
• Verify that investigators maintain qualified staff, appropriate facilities, and essential regulatory documents throughout the study.
• Ensure accurate source data verification and timely reporting of adverse events and unanticipated problems.
• Track and report issues using monitoring tools, communicate deviations, and coordinate with HRPP Director and IRB for critical violations.

Required profile

• Bachelor’s degree in biology, health or biomedical sciences (Master’s preferred).
• Minimum 5 years of experience as a clinical research monitor or in research quality assurance within an EMA/FDA‑regulated environment.
• Certification as a Clinical Research Associate (ACRP‑CCRA or SOCRA) or willingness to obtain within two years.

Required skills

• Good Clinical Practice (GCP) and ICH guideline knowledge.
• Clinical monitoring and source data verification.
• Adverse event and unanticipated problem reporting.
• Investigation product handling and documentation management.