Experienced Clinical Research Associate (remote-based)
Core
Conduct on-site clinical trial monitoring visits, verify source documents, manage study drug inventory, and report adverse events for biopharma clinical studies.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for Phase I-IV studies
Domain
Biotechnology, pharmaceutical, and medical device clinical research
Required skills
Clinical trial monitoring, source document verification, case report form review, regulatory document review, adverse event reporting, patient recruitment assessment, medical terminology, clinical research methodologies
Preferred skills
Drug therapy techniques knowledge, health-related field background
Technologies
Clinical trial management systems, electronic data capture (EDC), regulatory databases
Responsibilities
Conduct pre-study, initiation, monitoring, and closeout visits for research sites; Perform source document verification and case report form review; Perform regulatory document review; Conduct study drug inventory; Perform adverse event and serious adverse event reporting and follow-up; Assess patient recruitment and retention.
Seniority
Experienced, hands-on IC