The Unblinded CRA will perform monitoring activities, ensure protocol compliance, and maintain study documentation in accordance with ICH-GCP guidelines. They will also act as the primary point of contact for pharmacy site staff and contribute to audit and inspection readiness.
Join a sponsor-dedicated model supporting cutting-edge clinical trials in Germany. As an unblinded Clinical Research Associate , 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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