CRA II

Thermo Fisher Scientific seeks a Senior Clinical Research Associate (Level II) to conduct remote and on-site monitoring of clinical trial sites. The role involves ensuring protocol compliance, managing documentation, and coordinating with investigational sites across multiple trial environments to maintain data integrity and regulatory standards.

Responsibilities

• Monitor investigator sites using risk-based approaches and conduct source data review activities
• Document observations in reports and escalate deficiencies to clinical management
• Provide trial status updates and maintain clinical trial management systems
• Initiate investigator meetings, identify qualified sites, and ensure trial closeout compliance
• Facilitate communication between sites, sponsors, and project teams

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 expertise and attention to detail