Clinical Research Associate
Core
Manage and monitor assigned clinical research studies and investigative sites to ensure compliance with GCP, regulatory requirements, and quality standards.
Role type
Clinical Research Associate (CRA)
Builds
Clinical research studies for diagnostics, biotechnology, medical device, and pharmaceutical clients
Domain
Life sciences, clinical research, diagnostics, biotechnology, medical device, pharmaceutical
Deliverable
client delivery
Required skills
Site management, source data verification (SDV), protocol compliance, patient safety monitoring, regulatory knowledge (ICH-GCP, FDA, ISO, HIPAA), site feasibility assessment, TMF maintenance
Preferred skills
2+ years CRA or CRC experience, IVD/POC/molecular biology lab experience, EDC/CTMS/eTMF platform proficiency, Veeva Vault TMF/CDMS experience
Technologies
EDC, CTMS, eTMF, Veeva Vault TMF, Veeva CDMS
Responsibilities
Conduct qualification, initiation, routine, and closeout monitoring visits; perform source data review and verification; ensure informed consent and patient safety compliance; support site selection and feasibility; prepare monitoring reports and documentation; resolve study risks and compliance issues; maintain Trial Master Files.
Seniority
Early-career IC