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.
Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members for process improvement.
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
ICH-GCP guidelines
Investigational product assessment
Site process specialist
Audit readiness
Nice-to-have
Collaborative relationships with sites
Customer focus
Flexibility and adaptability
Team player or independent worker
Key Requirements
Bachelor's degree in life sciences or RN certification