Senior Clinical Research Associate
Core
Ensure successful protocol-level execution of clinical studies including start-up, execution, and close-out for assigned sites.
Role type
Senior Clinical Research Associate (Site Monitoring)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical studies
Domain
Pharmaceutical clinical research / Site monitoring
Deliverable
client delivery
Required skills
Site monitoring, protocol execution, regulatory compliance (GCP/ICH), audit/inspection readiness, CRA mentoring, training development, remote data review
Preferred skills
Health-related degree (Medical, Nursing, Pharmacy), country point of contact experience, global task force participation
Technologies
Clinical trial management systems, Integrated Data Review Plan (IDRP)
Responsibilities
Conduct site selection, activation, monitoring visits, and close-out; maintain clinical trial management systems; ensure audit and inspection readiness; coach and mentor CRAs; facilitate global training solutions; perform remote data review and provide feedback on site performance.
Seniority
Senior, hands-on IC with mentoring responsibilities