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
Biotech/Pharma, Clinical Research
Required skills
Clinical study management, GCP/FDA/ISO compliance, EDC systems, CTMS, Medical terminology, Protocol development, Site recruitment oversight, Data validation, SOP development, Cross-functional collaboration
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 compliance with ICH/GCP and IRB requirements, Review and reconcile data queries, Lead study team meetings, Support site recruitment, Mentor junior CRAs, Partner with Clinical Trials Manager, Liaise with regulatory authorities and CROs, Monitor site performance metrics
Seniority
Senior, hands-on IC
