FSP Sr CRA (Level I)

Thermo Fisher Scientific seeks a Senior Clinical Research Associate (Level I) to conduct remote and on-site monitoring of clinical trial sites across multiple therapeutic areas. The role involves assessing protocol compliance, managing documentation, and ensuring data integrity while supporting global pharmaceutical and biotech sponsors.

Responsibilities

• Conduct risk-based monitoring visits to assess protocol and regulatory compliance at investigational sites
• Review data accuracy through source document review, source document verification, and case report form activities
• Prepare monitoring reports and escalate deficiencies to clinical management for resolution
• Track trial status and maintain clinical trial management systems per study conventions
• Participate in investigator meetings and site initiation to ensure protocol compliance and ICH-GCP obligations

Requirements

• Bachelor's degree in life sciences or registered nursing certification
• 2+ years clinical research monitoring experience or equivalent combination of education and experience
• Oncology and cell therapy experience required
• Valid driver's license where applicable
• Strong understanding of ICH-GCP guidelines and applicable regulations
• Critical thinking and root cause analysis skills
• Excellent written and oral communication abilities