Senior Clinical Research Associate – West Coast

Senior Clinical Research Associate (CRA)-West Coast will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites (West Coast) to support ongoing and future OncoC4 clinical trials of novel immune therapies for various cancers. **CLINICAL SITE MONITORING AND MANAGEMENT** - Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial. - Conducts site visits including but not limited to Pre-study visits, initiation visits, interim monitoring visits, and close-out visits to ensure compliance with protocols, Sponsor SOPs, ICH/GCP, and all applicable regulations. - Performs remote and on-site monitoring & oversight activities to ensure data generated at the site are complete, accurate, and unbiased; protects subjects’ rights, safety, and well-being. - Collects, reviews, and monitors required regulatory documents for study start-up, maintenance, and close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, missing data and queries, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance. - Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates to upper management. - Performs investigational product accountability through physical inventory and record review. - Participates & provides inputs on site selection activities. - Supports audit/inspection activities as needed. - Works with in-house Clinical Trial Assistant to collect, review, and monitor required regulatory documentation. - Manages information and documentation in Clinical Trial Management System and electronic Trial Master File.