Fortrea

CRA II, Denmark

Fortrea  •  Region Hovedstaden, DK (Onsite)  •  1 month ago
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Job Description

This role is for upcoming future opportunities that may arise at Fortrea.

Join Fortrea as a CRA – exciting future opportunities across multiple sponsors

We’re excited to invite CRAs to join Fortrea, 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

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

Fortrea

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.

Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.

Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.

Together, exceptional is possible.

Learn more at Fortrea.com

Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Research Triangle Park, NC
Year Founded
Unknown
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