SrCRA
Core
Senior Clinical Research Associate conducting remote and on-site monitoring of investigator sites to ensure protocol and regulatory compliance, manage documentation, and guarantee subject rights and data reliability.
Role type
Senior IC clinical research associate (monitoring)
Builds
Clinical trial execution and data integrity for pharmaceutical/biotech sponsors
Domain
Clinical research / Life sciences
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP guidelines, site initiation and close-out, data review (SDR/SDV/CRF), investigator management, regulatory audit response, travel management
Preferred skills
Mentoring junior team members, process improvement, clinical trial management system (CTMS) proficiency, medical terminology knowledge
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits to assess compliance; initiate and close out clinical trial sites; review essential documents and conduct file reviews; track trial status and generate progress reports; facilitate communication between sites, clients, and project teams; respond to regulatory audits and inspections; mentor junior clinical team members.
Seniority
Senior, hands-on IC