Experienced CRA II/Sr CRA - US Northeast Region - Multiple Therapeutic Areas Available

Thermo Fisher Scientific seeks an experienced Clinical Research Associate II to monitor investigational sites across multiple therapeutic areas in the US Northeast. The role involves conducting remote and on-site visits to ensure protocol compliance, manage trial documentation, and coordinate with sponsor companies and clinical sites to maintain data integrity and regulatory standards.

Responsibilities

• Conduct risk-based site monitoring visits and assess protocol and regulatory compliance
• Perform source document review, source data verification, and case report form audits
• Identify site process failures, perform root cause analysis, and implement corrective actions
• Initiate and close-out clinical trial sites; retrieve trial materials and essential documents
• Facilitate communication between investigative sites, sponsors, and project teams

Requirements

• Bachelor's degree in life sciences or registered nursing certification
• Approximately 1 year clinical research monitoring experience or fellowship completion
• Strong understanding of ICH-GCP guidelines and applicable regulations
• Demonstrated critical thinking, root cause analysis, and problem-solving abilities
• Proficiency with risk-based monitoring concepts and Microsoft Office
• Excellent written and oral communication skills with medical personnel
• Valid driver's license; ability to travel 60-80% as needed