CRA II, Denmark

CRA – Exciting Future Opportunities

Join Fortrea as a CRA, where you'll work on a diverse portfolio of studies across multiple sponsors. This role offers strong exposure to different therapeutic areas, high-quality standards, and the opportunity to further develop your monitoring expertise in a global environment.

Key requirement:

• Minimum 2 years of clinical monitoring experience
• Preferably 1+ year experience in oncology studies

Summary of Responsibilities

• Manage clinical trial sites in line with Fortrea SOPs, ICH GCP and sponsor requirements
• Perform all monitoring visits (PSV, SIV, routine, close-out)
• Ensure patient safety by verifying informed consent and protocol adherence
• Maintain data integrity through SDV, query management, and data review
• Keep site regulatory documentation and eTMF up to date
• Oversee investigational product handling, storage, and accountability
• Ensure audit readiness and compliance with quality standards and CRA metrics
• Prepare monitoring plans, visit reports, and study documentation

On-site Monitoring Responsibilities

• Ensure site staff are trained and equipped to run the study
• Verify subject eligibility, consent, and protocol compliance
• Review source data for accuracy and completeness
• Identify and resolve data discrepancies and deviations
• Perform efficient monitoring activities in line with SOPs and travel policy
• Submit timely and accurate visit reports
• Track study progress, IP shipments, and serious adverse events
• Collaborate closely with study teams to meet timelines and deliverables

Additional Responsibilities

• Support investigator/site management activities
• Work with CTMS and other eClinical systems
• Attend investigator meetings and project calls
• Deliver site training and support onboarding of new team members
• Contribute to study planning and monitoring strategy

Qualifications & Experience

• Degree in life sciences or related field (or equivalent experience)
• Strong knowledge of ICH GCP and clinical trial processes
• Minimum 2 years of clinical monitoring experience
• Ability to monitor independently with minimal supervision
• Experience with SAE reporting and clinical data review
• Strong organizational, problem-solving, and communication skills

Additional Information

• Willingness to travel (~60% to study sites)