FSP_Sr. Clinical Research Assiciate (Sponsor: Roche) ─ with Sign-on Bonus
Core
Monitors clinical trial investigator sites using a risk-based approach to ensure compliance with protocols and regulations, verify data accuracy, and manage investigational product inventory.
Role type
Senior Clinical Research Associate (Sponsor)
Builds
Clinical trial sites and data integrity for pharmaceutical sponsors
Domain
Clinical Research / Pharmaceutical
Required skills
Risk-based monitoring, Root cause analysis, Data verification (SDR/SDV/CRF), Investigational product inventory management, ICH-GCP compliance, Protocol adherence, Site initiation and close-out, Regulatory documentation
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management System (CTMS) proficiency, Investigator payment process management
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites for compliance and data accuracy, Assess investigational product inventory, Document observations and deficiencies, Escalate and resolve site issues, Initiate and close out clinical trial sites, Conduct on-site file reviews, Provide trial status reports to management
