Unblinded CRA I based in Frankfurt or Ruhr Area
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AI Summary
Perform unblinded monitoring activities and oversee Investigational Products in accordance with ICH-GCP guidelines. Ensure protocol compliance, data integrity, and patient safety while managing relationships with site pharmacies.
Join a sponsor-dedicated model supporting cutting-edge clinical trials in Germany. As a Clinical Research Associate I or Clinical Research Associate II, 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 the Ruhrgebiet or Frankfurt region and across Germany 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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