Edwards Lifesciences Clinical Research Associate (French & English Speaking) in France
Support implementation of assigned clinical research projects in Europe related to specific products/topics according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, case report form review, data collection, site monitoring and auditing. Maintains close contact with clinical study site coordinators and physicians who are clinical investigators.
Document procedural case observations for insights in investigating post procedural events
Serve as key contact to assigned clinical sites throughout the study process
Is accountable for achieving and reporting on agreed clinical milestones
Supports study team in the interactions with Ethics Committees and Competent Authorities
Participates actively to project team meetings, as required
Ensures Audit readiness for internal, external and site Audits
Close collaboration with internal stakeholders to ensure proper project conduct
Develop new improved processes and perform implementation
Data review, safety reporting and complaint handling
Providing site and Edwards personnel training including reparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required
Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements
Reporting site enrollment progress including device accountability and enrollment deviations (inclusion/exclusion criteria, sequential enrollment) 6. Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.
Bachelor's Degree or 3 years of Experience equivalent in related field
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 skills
Good problem-solving and critical thinking skills
Moderate knowledge and understanding of cardiovascular science
Moderate understanding of cardiovascular anatomy, pathology and physiology
Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Clinical Research Associate (French & English Speaking) Location: Europe, Middle East, Africa, Canada (EMEAC)-France Job Number: 011096