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Fortrea

CRA II, Denmark

SoborgPosted 1 weeks ago
Full timemid

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

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.

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10001+ employees
Research Triangle Park, NC, US
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