Clinical Research Associate - FSP - Sweden

Clinical Research Associate position at Thermo Fisher Scientific's PPD division, supporting global clinical trials through site monitoring, data verification, and regulatory compliance activities. Remote role based in Sweden, requiring science background and clinical research experience.

Responsibilities

• Monitor investigator sites using risk-based approach and perform root cause analysis to identify process failures
• Ensure data accuracy through source document review, verification, and CRF assessments via on-site and remote activities
• Conduct investigational product inventory reviews and maintain regular contact with sites between visits
• Initiate and close out clinical trial sites while ensuring essential documents meet ICH-GCP and regulatory standards
• Escalate deficiencies to management and track resolution; provide trial status updates to Clinical Team Manager

Requirements

• University degree in science-related field
• Understanding of ICH-GCP, EU and FDA regulatory requirements
• Fluency in English and valid driver's license
• Proven clinical monitoring skills with multi-phase study experience
• Cell & Gene Therapy study background preferred
• Strong critical thinking, risk-based monitoring, and root cause analysis capabilities
• Proficiency in Microsoft Office and ability to learn clinical trial management systems