Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs
Job Summary
Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs.
Conducts site visits to assess protocol and regulatory compliance and manages required documentation, ensuring data will pass international quality assurance audits.
Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites.
Matching Summary
Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs.
Skills & Requirements
Must-have
ICH GCP compliance
FDA guidelines adherence
Source document verification
Investigational product assessment
Site initiation and close-out
Essential document management
Nice-to-have
Collaborative relationships
Effective communication
Adaptable in wide range of scenarios
Contributes to project team
Key Requirements
Bachelor's degree in life sciences or RN certification