Senior Clinical Research Associate - Sponsor dedicated - Netherlands - Home based (m/w/d)
Core
Senior Clinical Research Associate performing site monitoring visits (selection, initiation, monitoring, close-out) for a dedicated sponsor model in the Netherlands.
Role type
Senior Clinical Research Associate (Sponsor Dedicated)
Builds
Clinical study pipelines for specific pharmaceutical sponsors
Domain
Clinical Research / Life Sciences
Required skills
GCP and ICH guidelines, site monitoring, subject recruitment management, protocol administration, regulatory submissions, TMF/ISF management, medical writing
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, recruitment, CRF completion, and data queries; Ensure site documents are available for TMF and ISF maintenance; Create and maintain documentation regarding site management and monitoring visit findings; Collaborate with study team members for project execution support.
Seniority
Senior, hands-on IC
