CRA - FSP - Denmark

Thermo Fisher Scientific seeks a Level II Clinical Research Associate to monitor investigational sites and manage clinical trial compliance across multiple sponsors. The role involves remote and on-site monitoring activities to ensure protocol adherence, regulatory compliance, and data integrity in support of global clinical trials.

Responsibilities

• Conduct remote and on-site monitoring visits using risk-based approaches to assess protocol compliance and regulatory adherence
• Review source documents, case report forms, and investigational product records; escalate deficiencies to clinical management
• Initiate clinical trial sites, perform investigator meetings, and manage trial closeout activities
• Ensure essential documents are complete per ICH-GCP standards and update clinical trial management systems
• Facilitate communication between investigative sites, sponsors, and project teams; respond to audits and inspections

Requirements

• Bachelor's degree in life sciences or registered nursing certification
• Approximately one year clinical research monitoring experience or PPD Drug Development Fellowship completion
• Proven clinical monitoring skills and understanding of ICH-GCP guidelines
• Strong critical thinking, root cause analysis, and problem-solving abilities
• Excellent written and oral communication skills with medical personnel
• Proficiency in risk-based monitoring concepts and clinical trial management systems
• Valid driver's license where applicable