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CRA II, Denmark

Fortrea
  • US
    New York, New York, United States
  • US
    New York, New York, United States

Über

CRA Position 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)
  • New York, New York, United States

Sprachkenntnisse

  • English
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