Associé(e) de recherche clinique (ARC) principal(e) or Attaché(e) de recherche clinique II / Senior Clinical Research Associate or CRA 2
Core
Monitor and manage clinical trial sites to ensure studies are conducted and data reported in accordance with protocols, regulations, and sponsor requirements.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trials for life sciences clients
Domain
Life Sciences / Clinical Research
Deliverable
physical/clinical work
Required skills
Site monitoring, regulatory compliance (GCP/ICH), patient recruitment management, data quality assurance, TMF/ISF management, financial management, problem-solving
Preferred skills
Therapeutic area knowledge, cross-functional collaboration
Technologies
Microsoft Office (Word, Excel, PowerPoint), laptops, mobile devices (iPhone, iPad)
Responsibilities
Conduct site monitoring visits (selection, initiation, routine, closeout), manage subject recruitment plans, deliver protocol training to sites, assess site quality and integrity, track study progress and regulatory submissions, maintain Trial Master File (TMF) and Investigator Site File (ISF), generate monitoring reports and action plans, oversee site financial management.
Seniority
Mid-level, hands-on IC