Clinical Research Associate / In-House CRA

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact: You will be 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.

Key Responsibilities:

• Organizing and supervising clinical study
• Assist and conduct Clinical Monitoring activities
• 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
• Close collaboration 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, understanding of examinations/assessments required
• Reporting site enrollment progress including device accountability and protocol deviations (inclusion/exclusion criteria, sequential enrollment)
• Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation
• Processing adverse events
• Document procedural case observations for insights in investigating post procedural events
• Data review, safety reporting and complaint handling
• Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements
• Develop new improved processes and perform implementation
• Ensures Audit readiness for internal, external and site Audits
• Other incidental duties as assigned by management

What you'll need (Required):
Education and Experience:
Bachelor's Degree in related field, 3 years of previous related medical device and/or clinical experience required or
Associate's Degree or equivalent in related field, 5 years of previous field monitoring experience, quality assurance/control and regulatory compliance required.
What else we look for (Preferred):

Additional Skills:
• 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
• 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

What is it like to work at Edwards Lifesciences in Germany?

As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

Edwards Lifesciences in Germany also offers the following benefits:

• Competitive Compensation and Benefits package
• Flexible working hours, remote working
• Pension plan Risk
• Insurance Meal Benefits
• Service Awards Enhanced
• Leave Benefits
• Transportation Benefits
• Employee Stock Purchase Program
• Employee Assistance Program
• Comprehensive Wellness Program including onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities and much more.

Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.