Clinical Research Associate / Senior CRA

About the role

Edwards Lifesciences is looking for an experienced Clinical Research Associate (or Senior CRA, depending on experience) to join its Clinical Affairs team. The role will support medical‑device trials in cardiology, based in Germany or France, and will involve regular national travel to monitoring sites.

Key responsibilities

• Conduct on‑site clinical monitoring visits across assigned locations in Germany or France.
• Serve as the primary contact for each clinical site throughout the study lifecycle.
• Report on study milestones, enrollment progress, device accountability, and protocol deviations.
• Assist with interactions with Ethics Committees and Competent Authorities.
• Collect and audit Case Report Forms (CRFs) and supporting documentation.
• Process adverse events, document procedural observations, and handle safety reporting and complaints.
• Ensure audit readiness for internal, external, and site audits.
• Support training of site and Edwards personnel and contribute to process improvements.

Required profile

• Bachelor’s degree in a related field or equivalent relevant experience.
• Proven experience in medical‑device or pharmaceutical clinical trial site monitoring, preferably in Germany.
• Familiarity with different monitoring visit types and study stages.
• Driving licence and ability to travel nationally.
• Fluency in English and the local language (German or French).

Required skills

• Clinical monitoring and site management.
• Adverse event identification and reporting.
• Case Report Form (CRF) collection and verification.
• Regulatory compliance and quality‑assurance processes.
• Audit preparation and execution.