Perform and coordinate all aspects of the clinical monitoring and site management process, conducting 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, conducting 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 ensuring audit readiness.
Matching Summary
Perform and coordinate all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess protocol and regulatory compliance.
Skills & Requirements
Must-have
Risk-based monitoring approach
Root cause analysis (RCA)
ICH-GCP guidelines
Investigational product assessment
Site processes specialist
Nice-to-have
Collaborative relationships with investigational sites
Assist in preparation of project publications/tools