Cra 2 Senior Cra Denmark
ftden fortrea denmark aps
📍 Remote🌐 Remote🕐 1mo ago🔗 workday
Job Description
**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.
**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)
Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).