Perform site qualification, initiation, interim monitoring, site management, and close-out visits ensuring regulatory, ICH-GCP, and protocol compliance
Job Summary
Perform site qualification, initiation, interim monitoring, site management, and close-out visits ensuring regulatory, ICH-GCP, and protocol compliance.
Verify the process of obtaining informed consent, assess factors affecting subject safety and data integrity, and conduct Source Document Review.
Syneos Health offers career development, an inclusive culture, and benefits including a company car, health benefits, 401k match, and flexible PTO.
Matching Summary
Perform site qualification, initiation, interim monitoring, site management, and close-out visits ensuring regulatory, ICH-GCP, and protocol compliance.
Skills & Requirements
Must-have
Perform site qualification and initiation
Conduct interim monitoring visits
Ensure regulatory compliance
Verify informed consent process
Assess subject safety and data integrity
Perform Source Document Review
Drive query resolution to closure
Maintain Investigator Site File
Nice-to-have
Collaborate with passionate problem solvers
Adapt to changing priorities
Support subject recruitment strategies
Contribute to audit readiness
Key Requirements
Bachelor’s degree or RN
Knowledge of Good Clinical Practice/ICH Guidelines