Sr. Clinical Research Associate
Core
Senior Clinical Research Associate ensuring integrity, quality, and compliance of clinical trials for transplant patients.
Role type
Senior IC clinical research associate
Builds
Clinical trials for transplant patients
Domain
Healthcare / Clinical Research
Deliverable
physical/clinical work
Required skills
Clinical study management, GCP/FDA/ISO compliance, EDC systems, data reconciliation, site monitoring, protocol development, SOP creation, regulatory liaison, budget/resource management
Preferred skills
CCRC or CCRA certification, mentorship experience
Technologies
EDC systems, CTMS, Microsoft Office Suite
Responsibilities
Conduct site visits (selection, initiation, interim, close-out), ensure protocol adherence and patient safety, review and reconcile data queries, lead study team meetings, support site recruitment, mentor junior CRAs, liaise with regulatory authorities and CROs, monitor site performance metrics
Seniority
Senior, hands-on IC