Senior Clinical Research Associate

Responsibilities: Oversees the execution of clinical trials at investigative sites, acting as a liaison between the sponsor and sites to ensure data integrity and participant safety. Responsibilities include site initiation, monitoring, close-out, and mentoring junior staff.

Requirements: Requires a Bachelor's degree or RN license and a minimum of 5 years of experience as a CRA in pharmaceutical, hospital, or CRO settings. Candidates must have advanced knowledge of GCP/ICH/FDA regulations and be able to travel up to 70%.

Key skills: Clinical Trial Monitoring, Site Management, GCP, ICH Guidelines, FDA Regulations, EDC Systems, CNS Therapeutic Areas, Source Document Verification, Drug Accountability, Project Management, Clinical Trial Reporting, Case Report Form Review, Microsoft Office, Zoom, Adobe, English Proficiency

Keywords: Clinical Research Associate, CRA, Clinical Operations, FDA, ICH, GCP, EDC, CNS, Clinical Trial Reports, Source Document Verification, Site Management, Pharmaceutical, CRO, Case Report Forms, Drug Accountability, Clinical Monitoring Plan