CRA II/ Senior CRA, Denmark

Posted 6 Hours Ago
Be an Early Applicant
Søborg, Gribskov, Hovedstaden, DNK
In-Office
Senior level
Biotech
The Role
Manage clinical trial sites per SOPs, ICH GCP and sponsor requirements. Perform on-site monitoring (PSV, SIV, routine, close-out), SDV, query resolution, regulatory/eTMF maintenance, SAE reporting, IP accountability, visit reports, and site training. Collaborate with study teams, use CTMS/eClinical systems, support investigator management and ensure audit readiness while traveling to sites (~60%).
Summary Generated by Built In

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.

Skills Required

  • Degree in life sciences or related field (or equivalent experience)
  • Minimum 2 years of clinical monitoring experience
  • 1+ year experience in oncology studies
  • Strong knowledge of ICH GCP and clinical trial processes
  • Experience with SAE reporting and clinical data review
  • Experience using CTMS and other eClinical systems
  • Experience maintaining eTMF and regulatory documentation
  • Ability to monitor independently with minimal supervision
  • Willingness to travel approximately 60% to study sites
  • Strong organizational, problem-solving, and communication skills
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The Company
HQ: Durham, NC
10,811 Employees

What We Do

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

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