Clinical Research Associate / Senior CRA, Medical Devices
Core
Conduct clinical monitoring for medical device trials in Cardiology to ensure study integrity, protocol adherence, and patient safety across clinical sites in France.
Role type
Senior Clinical Research Associate (Medical Devices)
Builds
Clinical evidence demonstrating effectiveness and safety of structural heart disease and critical care monitoring innovations
Domain
Medical Devices / Cardiology
Required skills
Clinical trial site monitoring, Medical device trial experience, Regulatory compliance, Adverse event reporting, Case Report Form (CRF) management, Protocol deviation tracking, Ethics Committee interaction, Site enrollment management, Device accountability, Audit preparation
Preferred skills
Cardiology study experience, MS Office Suite proficiency, Problem-solving, Critical thinking, Relationship management
Technologies
MS Office Suite
Responsibilities
Conduct clinical monitoring visits at assigned sites, Serve as key contact for clinical sites, Report on clinical milestones, Collaborate with Ethics Committees and Competent Authorities, Assist in site and personnel training, Collect and audit Case Report Forms (CRFs), Process adverse events and device-related complications, Ensure audit readiness for internal and external audits
Seniority
Senior, hands-on IC