Clinical Research Associate (CRA) Europe (m/f/d)
About us
As a global manufacturer of high-quality medical devices, we at optimed are proud to make an important contribution to people’s health every day. Working with us means a conscious desire to take on responsibilities and contribute to a well-functioning team.
To strengthen our international team, we are looking for a
Clinical Research Associate (CRA) – Europe (m/f/d)
We are seeking an experienced Clinical Research Associate (CRA) to support post-market clinical studies for neurovascular and peripheral vascular interventional medical devices across Europe. The role focuses on ensuring clinical trial compliance with ICH-GCP, ISO 14155, EU Medical Device Regulation (MDR), and local regulatory requirements. The ideal candidate will have a strong background in medical device clinical monitoring within Europe, particularly in Germany, and will be capable of independently managing multiple trial sites.
Your contribution to our mutual success:
- Manage site activities for assigned clinical sites in Europe (with emphasis on Germany), including site feasibility, initiation, monitoring, and close-out visits.
- Ensure study conduct complies with the approved protocol, Good Clinical Practice (GCP), ISO 14155, and relevant national regulations.
- Perform source data verification (SDV), review case report forms (CRFs), manage investigational device accountability, and track safety reporting.
- Establish and maintain effective communication with Principal Investigators (PIs), site staff, and clinical research coordinators (CRCs) to ensure study progress and data quality.
- Prepare monitoring visit reports, track study progress, identify risks and issues, and contribute to resolution plans.
- Support essential document preparation, submission to ethics committees and competent authorities, and contract negotiation processes.
- Collaborate cross-functionally with Medical Affairs, Data Management, Biostatistics, and Regulatory Affairs teams to achieve study milestones.
Your Qualifications & Experience:
Essential Requirements:
- Bachelor's degree or higher in Medicine, Pharmacy, Life Sciences, or a related discipline.
- Minimum of 3 years of independent monitoring experience in the medical device or pharmaceutical industry, preferably with exposure to neurovascular, peripheral vascular, cardiology, or interventional device studies.
- Solid knowledge of EU Medical Device Regulation (MDR), ICH-GCP, ISO 14155, and local regulatory and ethics submission processes.
- Ability to manage multiple sites independently and willing to travel extensively.
- Fluent in both German and English (written and spoken), with the ability to communicate complex medical information clearly.
- Strong organizational, problem-solving, and team collaboration skills.
Preferred Qualifications:
- Hands-on experience in post-market clinical studies (PMS/PMCF) or regulatory-focused clinical trials.
- Familiarity with Electronic Data Capture (EDC) systems and clinical trial management tools.
