Are you our new Excellence Maker? 

Join Aurevia in our journey of quality excellence! We are seeking an experienced Senior Clinical Research Associate (CRA) for a full-time position based in Northern Germany. This role requires fluency in English and German and offers the opportunity to work with an international team supporting clinical trials with pharmaceutical, medical devices and in-vitro devices. 

Your Qualifications: 

• Educational Background: Degree in life sciences, pharmacy, biomedicine, or a related field. 

• Experience: At least 5 years of full-time experience as a CRA in clinical trials for pharmaceuticals.

• Regulatory Knowledge: Strong understanding of ICH-GCP, EU CTR 536/2014, and other applicable pharmaceutical regulations. 

• Authority Coordination: Experience in submitting applications to regulatory authorities. 

• Technical Skills: Proficiency in electronic documentation management systems (eTMF, CTMS, eCRF) and Microsoft 365 tools (Excel, Word, PowerPoint). 

• Soft Skills: Excellent organizational, communication, and problem-solving abilities. Ability to work independently and within a team. 

• Languages: Fluency in German and professional working proficiency in English (oral and written). 

• Travel Readiness: Willingness to travel as required; a valid driver's license is an advantage. 

Your Responsibilities: 

• Act as the primary point of contact for sites and investigators in Germany. 

• Conduct feasibility process and site selection. 

• Plan and execute pre-study, initiation, monitoring, and close-out visits, including reporting and documentation. 

• Train investigators and site staff on study protocols and compliance. 

• Manage site files (ISF) and Trial Master File (TMF). 

• Perform source data verification and ensure compliance with study guidelines. 

• Support contract negotiations and study document preparation. 

What We Offer: 

• A dynamic and growing company with modern working practices. 

• Autonomy in your role and the ability to shape your tasks. 

• Flexible work arrangements, including remote work options. 

• Competitive salary and benefits based on experience. 

• An international professional network and opportunities for career growth. 

Application Process: 

We review applications on a rolling basis and will fill the position as soon as we find the right candidate. If you are interested, please submit your CV, cover letter and salary expectations by April 24th, 2025. For more details about the position, contact Kirsten Sander, Country Manager (kirsten.sander@aurevia.com).