Ich-gcp and good pharmacoepidemiology practice compliance
Site qualification initiation interim monitoring close-out visits
Source document review and crf data verification
The role involves performing comprehensive site management activities including qualification, initiation, interim monitoring, and close-out visits to ensure regulatory compliance
Job Summary
The role involves performing comprehensive site management activities including qualification, initiation, interim monitoring, and close-out visits to ensure regulatory compliance.
Syneos Health is committed to a Total Self culture that values diversity of thoughts, backgrounds, and perspectives to create an inclusive workplace.
Candidates must demonstrate the ability to manage travel up to 75% regularly while ensuring data integrity and subject safety across assigned sites.
Matching Summary
The role involves performing comprehensive site management activities including qualification, initiation, interim monitoring, and close-out visits to ensure regulatory compliance.
Skills & Requirements
Must-have
ICH-GCP and Good Pharmacoepidemiology Practice compliance
Site qualification initiation interim monitoring close-out visits
Source document review and CRF data verification
Investigator Site File reconciliation with Trial Master File
Protocol deviation and pharmacovigilance issue assessment
Travel up to 75% on a regular basis
Nice-to-have
Experience with real world late phase study designs
Chart abstraction activities and data collection skills
Ability to train junior staff members
Knowledge of local treatment patterns and HCP associations
Collaboration with medical science liaisons and sponsor affiliates
Key Requirements
Bachelor's degree or RN in related field
Knowledge of ICH/GCP Guidelines and applicable regulations
Excellent computer skills and technology adaptability
Strong communication presentation and interpersonal skills
US work authorization required for site access
Work Rights
Must be able to provide medical and personal information for facility access; US only