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Fortrea

Unblinded CRA based in Germany (Ruhrgebiet)

Posted 4 days ago
2-5 years experience
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AI Summary

You will perform unblinded monitoring activities to ensure protocol compliance, data integrity, and patient safety at assigned clinical sites. Additionally, you will manage investigational products and maintain accurate study documentation while acting as the primary contact for site pharmacy staff.

Join a sponsor-dedicated model supporting cutting-edge clinical trials in DACH. As an unblinded Clinical Research Associate (CRA I or CRA II level) , you will contribute to high-quality clinical research delivery while gaining strong exposure to unblinded study activities in a collaborative global environment.


Key Responsibilities

  • You will perform unblinded monitoring activities in line with ICH-GCP guidelines and applicable regulations, including Investigational Product oversight
  • You will ensure protocol compliance, data integrity, and patient safety at assigned sites
  • You will maintain accurate and complete study documentation, including eTMF and regulatory files
  • You will build strong relationships with site staff, acting as the primary point of contact for site management (pharmacy only)
  • You could contribute to audit readiness and ensure inspection preparedness at site level

Required Qualifications

  • Bachelor’s degree in Life Sciences or related field (or equivalent experience)
  • Initial experience in clinical research as a CRA with at least 1 year of monitoring experience
  • Understanding of ICH-GCP guidelines and clinical trial processes
  • Strong interest and knowledge in unblinded study conduct and Investigational Product management
  • Fluency in German and English (written and spoken)
  • Willingness to travel within Germany and Austria as required
  • Strong organizational skills with attention to detail

What We Offer

  • Opportunity to work in a sponsor-dedicated environment on innovative studies
  • Structured onboarding and continuous development programs
  • Flexible working model supporting work-life balance
  • Access to global career growth opportunities within clinical operations
  • Inclusive and collaborative culture with employee resource groups and wellbeing initiatives

If you are looking to build your clinical monitoring career within a high-impact and supportive environment, we encourage you to apply and grow with us.

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