Edwards Lifesciences CRA Germany in Unterschleissheim, Germany
Responsible for remotely supporting field clinical research associate/ site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.
• Organizing and supervising clinical study
o Assist and conduct Clinical Monitoring activities
o Serve as key contact to assigned clinical sites throughout the study process
o Is accountable for achieving and reporting on agreed clinical milestones
o Supports study team in the interactions with Ethics Committees and Competent Authorities
o Participates actively to project team meetings, as required
o Close collaboration with internal stakeholders to ensure proper project conduct
o Assist in Providing site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required
o Reporting site enrollment progress including device accountability and protocol deviations (inclusion/exclusion criteria, sequential enrollment) 6. Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.
• Processing adverse events
o Document procedural case observations for insights in investigating post procedural events
o Data review, safety reporting and complaint handling
o Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements
• Identifies and supports process improvement opportunities and implementation
• Ensures Audit readiness for internal, external and site Audits
• Other incidental duties as assigned by management
Education and Experience:
Bachelor's Degree or equivalent in in related field , 1 year years experience of previous related medical device and/or clinical experience Required
Other: Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) Preferred and
Other: Experience in interventional cardiology or cardiothoracic surgery Preferred
• Good computer skills in MS Office Suite and ability to operate general office machinery
• Good written and verbal communication skills, presentation and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Adhere to all EHS rules and requirements 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
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 13,000 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.