Perform and coordinate all aspects of the clinical monitoring and site management process, including remote or on-site visits to assess protocol and regulatory compliance
Job Summary
Perform and coordinate all aspects of the clinical monitoring and site management process, including remote or on-site visits to assess protocol and regulatory compliance.
Ensure the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.
Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording, while also participating in investigator meetings and site initiation/close-out.
Matching Summary
Perform and coordinate all aspects of the clinical monitoring and site management process, including remote or on-site visits to assess protocol and regulatory compliance.
Skills & Requirements
Must-have
Risk-based monitoring approach
ICH-GCP guidelines
Site processes specialist
Data accuracy through SDR, SDV and CRF review
Investigational product assessment
Audit readiness
Nice-to-have
Collaborative relationships with investigational sites