Unblinded CRA based in Germany (Ruhrgebiet)

Reposted Yesterday
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Hiring Remotely in Munich, Bayern, DEU
In-Office or Remote
Junior
Biotech
The Role
Perform unblinded monitoring per ICH-GCP, oversee investigational product handling, ensure protocol compliance, data integrity, and patient safety at assigned sites. Maintain study documentation (eTMF, regulatory files), manage site relationships (pharmacy-focused), support audit readiness and inspection preparedness, and travel across Germany as required.
Summary Generated by Built In

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.

#LI-GQ1 #LI-Remote

Learn more about our EEO & Accommodations request here.

Skills Required

  • Bachelor's degree in Life Sciences or related field (or equivalent experience)
  • At least 1 year of monitoring experience as a Clinical Research Associate
  • Understanding of ICH-GCP guidelines and clinical trial processes
  • Knowledge and interest in unblinded study conduct and investigational product management
  • Fluency in German and English (written and spoken)
  • Willingness to travel within Ruhrgebiet/Frankfurt region and across Germany
  • Strong organizational skills and attention to detail
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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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