FSP_Principle Clinical Research Associate (Sponsor: Roche) ─ with Sign-on Bonus
Core
Monitors investigator sites using a risk-based approach to ensure compliance with ICH-GCP, verify data accuracy, and manage investigational product inventory.
Role type
Senior Clinical Research Associate (Risk-Based Monitoring)
Builds
Clinical trial sites and compliant data sets for pharmaceutical sponsors
Domain
Clinical Research / Pharma
Required skills
Risk-based monitoring, Root cause analysis, ICH-GCP compliance, Data verification (SDR/SDV/CRF), Investigational product management, Regulatory documentation, Site initiation and close-out, Clinical trial management systems
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Stakeholder management, Microsoft Office proficiency
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites for compliance and data accuracy, Assess investigational product inventory, Document observations and escalate deficiencies, Initiate and close out clinical trial sites, Conduct on-site file reviews, Provide trial status tracking reports
Seniority
Senior, independent IC
