Senior CRA
On-site · Reading, England, United Kingdom or Manchester, England, United Kingdom
Job Summary
Senior CRA to perform on-site monitoring visits (initiation, monitoring and close-out) in compliance with GCP/ICH; drive subject recruitment plans with sites; provide protocol and study training; ensure ISF/TMF compliance; track regulatory submissions, recruitment, CRF completion, data queries, and visit reports; cooperate with study team to support project execution; may support start-up phase. Requires independent on-site monitoring experience, strong GCP/ICH knowledge, life sciences degree or equivalent, and travel flexibility.
Required Qualifications
- Experience of independent on-site monitoring
- Knowledge of Good Clinical Practice (GCP) and ICH guidelines
- Life science degree educated or equivalent industry experience
- Flexibility to travel to sites
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