Associé(e) de recherche clinique (ARC) principal(e) / Senior Clinical Research Associate, Sponsor Dedicated
Core
Perform site monitoring and management for clinical trials across various protocols and therapeutic areas, ensuring regulatory compliance and study progress.
Role type
Senior Clinical Research Associate (Sponsor Dedicated)
Builds
Clinical trial execution and data integrity for life sciences sponsors
Domain
Clinical Research / Life Sciences
Required skills
GCP/ICH regulatory knowledge, site monitoring, subject recruitment management, protocol training, quality assurance, TMF/ISF management, data query resolution, financial management, mentorship
Preferred skills
Bachelor's degree in scientific discipline or healthcare, strong therapeutic knowledge, computer proficiency (MS Office, mobile devices)
Responsibilities
Conduct site monitoring visits (selection, initiation, monitoring, close-out), manage subject recruitment plans, administer protocol training, evaluate site quality and integrity, track regulatory submissions and study progress, maintain TMF and ISF documentation, mentor clinical staff, support project execution and financial management
Seniority
Senior, hands-on IC