Senior Clinical Research Associate
Company: AL Solutions Agency
- Location: Germany
- Seniority: Mid level
- Employment type: Full-time
- Posted: 5 days ago
- Offer language: English
Job description
Chloe O'Shea is proud to partner with a leading global CRO delivering cutting-edge solutions in clinical development. We are seeking an experienced Clinical Research Associate (CRA) to join a dynamic and dedicated team in Germany for an exciting single-sponsor opportunity. This position offers a sustainable workload of 6–8 site visits per month, allowing you to focus on high-quality monitoring and meaningful site engagement.
The Role
As a Clinical Research Associate (CRA), you will play a critical role in overseeing the execution of clinical trials across Germany. Collaborating closely with investigative sites and sponsor teams, you will ensure compliance with study protocols, ICH-GCP standards, and German regulatory requirements. This is an ideal opportunity for professionals passionate about advancing global research within a supportive, innovation-driven environment.
Key Responsibilities
- Conduct site qualification, initiation, monitoring, and close-out visits across Germany.
- Ensure clinical trial sites operate in compliance with ICH-GCP, German regulatory guidelines (e.g. AMG, GCP-V), and sponsor protocols.
- Verify source data, oversee investigational product accountability, and ensure completeness of site documentation.
- Identify and escalate site-level issues proactively to support timely resolution and continuous study progress.
- Build strong, collaborative relationships with site personnel and sponsor stakeholders.
- Provide training and support to site staff to ensure protocol adherence and data accuracy.
- Maintain up-to-date documentation and manage clinical systems including CTMS, eTMF, and EDC platforms.
Requirements
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of independent monitoring experience as a CRA in Germany.
- In-depth knowledge of ICH-GCP and the German clinical regulatory landscape.
- Experience across multiple therapeutic areas, with preference for Oncology or Immunology studies.
- Fluent in German and English, both written and spoken.
- Excellent organizational, communication, and time-management skills.
What’s in It for You?
- Competitive compensation and a comprehensive benefits package.
- Opportunities for career growth within a global leader in clinical research.
- Flexible working arrangements with manageable travel expectations.
- Access to innovative technology platforms and global study networks.
- Commitment to work-life balance, mental well-being, and ongoing professional development.
If you’re an ambitious CRA eager to contribute to impactful research within a supportive and high-performing team, we want to hear from you. Apply today and take the next step in your clinical research career in Germany!
