Clinical Research Associate II - Sponsor dedicated - Netherlands - Home based (m/w/d)
Core
Perform site monitoring visits (selection, initiation, monitoring, close-out) for clinical studies in the Netherlands, ensuring adherence to GCP and ICH guidelines while managing subject recruitment and data integrity.
Role type
Senior Clinical Research Associate (Sponsor Dedicated Model)
Builds
Clinical study pipelines for specific pharmaceutical sponsors
Domain
Life Sciences / Clinical Research
Required skills
Site monitoring, subject recruitment management, protocol administration, regulatory compliance (GCP/ICH), TMF/ISF management, medical writing, cross-cultural communication
Preferred skills
None stated
Technologies
None stated
Responsibilities
Perform site monitoring visits in accordance with GCP and ICH guidelines; Work with sites to adapt and track subject recruitment plans; Administer protocol and study training to assigned sites; Evaluate quality and integrity of study site practices; Manage study progress including regulatory submissions, enrollment, and CRF completion; Ensure site documents are available for filing in the Trial Master File (TMF); Create and maintain documentation regarding site management and monitoring visit findings.
Seniority
Mid-Senior, hands-on IC
