FSP CRA I or II

Thermo Fisher Scientific seeks a Clinical Research Associate (Level I or II) to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation. This remote-based role involves coordinating site visits, conducting data reviews, and collaborating with sponsors and study sites across multiple trials.

Responsibilities

• Conduct remote and on-site monitoring visits using risk-based approach to assess protocol compliance and regulatory adherence
• Review source documents, case report forms, and investigational product records; escalate deficiencies and corrective actions
• Initiate and close out clinical trial sites; ensure essential documents are complete per ICH-GCP standards
• Maintain regular contact with investigative sites; provide trial status updates and progress reports to clinical management
• Facilitate communication between sites, sponsor, and project team; respond to audits and regulatory inspections

Requirements

• Bachelor's degree in life sciences or current RN certification
• Approximately 1 year clinical research monitoring experience or PPD Drug Development Fellowship completion
• Proficiency with ICH-GCP guidelines, regulations, and risk-based monitoring concepts
• Strong critical thinking, root cause analysis, and problem-solving capabilities
• Excellent written and oral communication skills with medical personnel
• Solid Microsoft Office knowledge and ability to learn clinical trial management systems
• Valid driver's license where applicable; willingness to travel frequently