Perform site qualification, initiation, monitoring, and close-out visits
Ensure regulatory, ich-gcp, and protocol compliance
Assess site processes and data integrity
Syneos Health is a leading fully-integrated life sciences services organization accelerating customer success
Job Summary
Syneos Health is a leading fully-integrated life sciences services organization accelerating customer success.
Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
Matching Summary
Syneos Health is a leading fully-integrated life sciences services organization accelerating customer success.
Skills & Requirements
Must-have
Perform site qualification, initiation, monitoring, and close-out visits
Ensure regulatory, ICH-GCP, and protocol compliance
Assess site processes and data integrity
Verify informed consent and subject safety
Manage investigational product (IP) handling and reconciliation
Maintain Investigator Site File (ISF) and reconcile with TMF
Nice-to-have
Act as primary liaison with study site personnel
Support subject recruitment and retention strategies
Adapt to changing priorities and achieve goals
Provide guidance on audit readiness standards
Key Requirements
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines