Sr CRA

Thermo Fisher Scientific seeks a Senior Clinical Research Associate to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation across remote and on-site settings. The role involves risk-based monitoring, data verification, regulatory oversight, and collaborative site management across multiple sponsor environments.

Responsibilities

• Monitor investigator sites using risk-based approach; identify compliance failures and implement corrective actions
• Verify data accuracy through source data review, verification, and case report form evaluation
• Prepare monitoring reports, trial status updates, and progress documentation for clinical management
• Conduct investigator meetings, initiate qualified trial sites, and manage trial closeout procedures
• Maintain essential regulatory documents and ensure audit readiness across study systems

Requirements

• Bachelor's degree in life sciences or registered nursing certification
• 2+ years clinical research monitoring experience or equivalent
• Strong understanding of ICH-GCP guidelines and applicable regulations
• Critical thinking and root cause analysis skills for problem-solving
• Excellent oral and written communication abilities
• Risk-based monitoring knowledge and application expertise