Ich-gcp and good pharmacoepidemiological practices knowledge
Site qualification, initiation, interim monitoring, and close-out visits
Source document review and case report form verification
The role involves performing comprehensive site management activities including qualification, initiation, monitoring, and close-out visits to ensure protocol compliance
Job Summary
The role involves performing comprehensive site management activities including qualification, initiation, monitoring, and close-out visits to ensure protocol compliance.
Syneos Health is committed to a Total Self culture that values diversity of thoughts, backgrounds, and perspectives to create an inclusive environment.
Candidates must be able to manage required travel of 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, monitoring, and close-out visits to ensure protocol compliance.
Skills & Requirements
Must-have
ICH-GCP and Good Pharmacoepidemiological Practices knowledge
Site qualification, initiation, interim monitoring, and close-out visits
Source document review and case report form verification
Investigator Site File reconciliation with Trial Master File
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
Collaboration with medical science liaisons and sponsor affiliates
Ability to adapt quickly to changing priorities
Strong interpersonal and presentation skills
Key Requirements
Bachelor's degree or RN in a related field
Knowledge of Good Clinical Practice/ICH Guidelines
US work authorization required for site access
Work Rights
Must have US work authorization for facility access