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).
Cra 2 Senior Cra Denmark at ftden fortrea denmark aps | MergeJobs