Senior Clinical Research Associate (CRA) - Client-dedicated - ITALY
Core
Monitors clinical trial investigator sites to ensure compliance with protocols and regulations, ensuring data accuracy and product integrity.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial operations for pharmaceutical, biotech, and CRO clients
Domain
Life Sciences / Clinical Research / Cell & Gene Therapy
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, data verification (SDR/SDV), regulatory compliance (ICH-GCP, EU, FDA), site initiation and close-out, investigator payment processing, clinical trial management systems
Preferred skills
Cell & Gene Therapy study experience, medical/therapeutic area knowledge, all study phases experience (start to close-out)
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through document review; assess investigational product inventory; initiate and close out clinical trial sites; track trial status and provide progress reports; participate in investigator meetings and payment processes.
Seniority
Senior, hands-on IC
