CRA II
Core
Perform site monitoring visits (selection, initiation, monitoring, close-out) for interventional clinical studies to ensure adherence to GCP and ICH guidelines.
Role type
Clinical Research Associate (Site Monitoring)
Builds
Clinical trial data integrity and regulatory compliance for life sciences sponsors
Domain
Clinical Research / Life Sciences
Required skills
Site monitoring, GCP/ICH guidelines, subject recruitment tracking, protocol administration, TMF/ISF management, data query resolution, regulatory submission tracking
Preferred skills
None stated
Technologies
None stated
Responsibilities
Conduct site monitoring visits, drive subject recruitment plans, administer protocol training, evaluate site quality and integrity, manage study progress (enrollment, CRF completion), maintain Trial Master File and Investigator's Site File, generate visit reports and follow-up letters, liaise with study teams
Seniority
Mid-level, hands-on IC
