Clincial Research Associate​/Senior CRA

Clincial Research Associate / Senior CRA

Overview

The Clinical Affairs team is looking for an experienced Clinical Research Associate or Senior CRA (depending on experience) to join our team in Germany and lead site monitoring activities for medical device trials in Cardiology.

• Conduct clinical monitoring activities at sites across Germany.
• Serve as key contact to assigned clinical sites throughout the study process.
• Accountable for achieving and reporting on agreed clinical milestones.
• Support study team interactions with Ethics Committees and Competent Authorities.
• Participate actively in project team meetings, as required.
• Collaborate with internal stakeholders to ensure proper project conduct.
• Assist in providing site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, and understanding of examinations/assessments required.
• Report site enrollment progress including device accountability and protocol deviations.
• Collect completed Case Report Forms (CRF) and confirm and audit supporting documentation.
• Process adverse events.
• Document procedural case observations for insights in investigating post‑procedural events.
• Review data, safety reporting and complaint handling.
• Identify and report adverse events and device‑related complications in accordance with regulatory and internal requirements.
• Develop new improved processes and perform implementation.
• Ensure audit readiness for internal, external and site audits.
• Other incidental duties as assigned by management.

• Bachelor's Degree in a related field, and/or proven record of strong relevant experience.
• Previous related medical device and/or clinical experience required.
• Previous clinical trial site monitoring experience in Germany within a Medical Device or Pharmaceutical setting.
• Experience with different types of monitoring visits and in different study stages.
• Quality assurance and regulatory compliance in a clinical research setting.
• Driving licence required.
• Fluency in both German and English language is essential.

• Excellent communication and organizational skills.
• Proven expertise in MS Office Suite and ability to operate general office machinery.
• Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management.
• Good problem‑solving and critical thinking skills.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
• Cardiology and/or medical device study experience desirable.
• Driving licence required.

This role will require travel both regional and national for monitoring visits and some international travel.

• Competitive Compensation and Benefits package.
• Insurance Meal Benefits.
• Leave Benefits.
• Employee Stock Purchase Programme.
• Employee Assistance Programme.
• Comprehensive Wellness Programme including onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities and much more.

Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.

Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.