Clinical Research Associate (CRA)
Core
Primary site contact and manager responsible for protocol performance, compliance, and data integrity across clinical research sites.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trial data integrity and regulatory compliance for assigned sites
Domain
Healthcare / Clinical Research / Pharma
Deliverable
physical/clinical work
Required skills
Site management, Clinical trial monitoring, ICH-GCP compliance, Adverse event reporting, Protocol adherence, Regulatory documentation management, Site selection and validation, Root cause analysis, Data interpretation, IT proficiency (MS Office, CTMS, eTMF)
Preferred skills
Experience in bio/pharma/CRO environment, Territory growth strategy, Audit/inspection support, Co-monitoring, Mentorship
Technologies
CTMS, eTMF, Adverse Event Reporting Systems, Clinical applications
Responsibilities
Conduct remote and on-site monitoring visits (initiation, monitoring, close-out), Manage site readiness and performance, Coordinate study start-up and close-out activities, Prepare visit and non-visit reports, Identify and resolve compliance issues, Support audit and inspection activities, Develop new clinical research sites
Seniority
Mid-to-Senior, hands-on IC
