CRA II/ Senior CRA, Denmark

Join Fortrea as a CRA – exciting future opportunities for a single sponsor

We’re excited to invite CRAs to join Fortrea, where you’ll work with one dedicated sponsor.

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)

Learn more about our EEO & Accommodations request here.