Ich-gcp and good pharmacoepidemiology practice knowledge
Site qualification, initiation, interim monitoring, and 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 protocol compliance
Job Summary
The role involves performing comprehensive site management activities including qualification, initiation, interim monitoring, and close-out visits to ensure protocol compliance.
Syneos Health is committed to building an inclusive culture where colleagues can authentically be themselves while driving impact for patients.
Candidates must demonstrate the ability to manage travel of up to 75% regularly while ensuring project objectives and timelines are met.
Matching Summary
The role involves performing comprehensive site management activities including qualification, initiation, interim monitoring, and close-out visits to ensure protocol compliance.
Skills & Requirements
Must-have
ICH-GCP and Good Pharmacoepidemiology Practice knowledge
Site qualification, initiation, interim monitoring, and close-out visits
Source document review and CRF data verification
Informed consent process verification and documentation
Investigator Site File maintenance and reconciliation
Travel up to 75% required on a regular basis
Nice-to-have
Experience with Real World Late Phase study designs
Ability to train junior staff members
Strong interpersonal and presentation skills
Proactive site identification based on local treatment patterns
Collaboration with medical science liaisons and sponsor affiliates
Key Requirements
Bachelor's degree or RN in a related field
Knowledge of ICH/GCP Guidelines and applicable regulations
Excellent computer skills and ability to embrace new technologies