Clinical Research Associate / Senior CRA

Overview

Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease . With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.

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.

In the role of Clinical Research Monitoring Specialist (CRA / Senior CRA), UK and Ireland, you will support implementation of assigned clinical research projects across Europe, with field-based monitoring at sites in the UK and Ireland. Your focus will be on specific products or topics, ensuring full compliance with both internal standards and regional regulatory requirements. You will be involved in obtaining human use approvals from Ethics Committees, reviewing case report forms, data collection, site monitoring and audits. You will also maintain close contact with clinical study site coordinators and physicians acting as clinical investigators.

We are looking for an experience Clinical Research Associate / Senior CRA to conduct field based monitoring for Heart Failure focused Medical Device studies. We can consider candidates based in either the UK or Republic of Ireland.

Regular national / regional travel will be expected within this role, covering sites in both the UK and Ireland.

How you’ll make an impact:

• Field monitoring of clinical studies and data collection for clinical trials. Assess documentation, reports, records, transcripts, and exam results for consistency with case report forms, and confirm that subject documentation aligns with the study hypothesis. Monitor clinical trial/study safety in accordance with protocols, GCP (Good Clinical Practices), and applicable regulatory requirements (e.g., ISO 14155).
• Deliver technical training on GCP, regulatory requirements (e.g., ISO 14155), study protocols, databases, compliance, device accountability, adverse event reporting, investigation protocols, amendments, and regulatory documentation.
• Provide oversight and insights into trial activities (e.g., protocol compliance, enrolment, deviations, data quality) to principal investigators and support staff. Contribute to study site management activities including Institutional Review Board (IRB) coordination, contracts, training, and process improvements.
• Verify trial/study data, maintain internal and external regulatory documentation, and support audits to ensure appropriate trial/study documentation and accurate source data recording.
• Validate investigational device accountability by tracking devices from Edwards to the field sites and through final disposition.
• Other incidental duties.
  
  

What you'll need (Required):

• Previous clinical monitoring experience at sites in the UK and/or Ireland, preferably with some experience in cardiology studies
• Bachelor's Degree in a related field
  
  

What else we look for (Preferred):

• Medical device clinical trial experience would be preferred.
• Moderate understanding of cardiovascular science, including anatomy, pathology, and physiology
• Familiarity with medical device regulations, documentation requirements, device accountability, and adverse event reporting
• Strong written and verbal communication skills, including presentation, negotiation, and stakeholder relationship management
• Excellent organizational, problem-solving, and critical thinking abilities
• Ability to manage confidential information with professionalism and discretion
• High attention to detail and accuracy in a fast-paced, deadline-driven environment
• Ability to build productive working relationships across internal and external teams
• Comfortable working cross-functionally and representing the team on project-based initiatives
• Proficiency in Microsoft Office Suite
• Commitment to safety, compliance, and adherence to company protocols (e.g. pandemic guidelines, Environmental Health & Safety standards)
  
  

What is it like to work at Edwards Lifesciences?

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).

We offer

• Competitive Compensation and Benefits package
• Flexible working hours, remote working
• Pension Scheme (double matching)
• Risk Life Insurance and Group Income Protection
• Private Medical Plan
• Service Awards
• Enhanced Sick Leave Benefits (Income Protection)
• Employee Stock Purchase Program
• Employee Assistance Program
• Comprehensive Wellness Program including health and wellness subsidy, onsite gym, massages, fresh fruit in the office, financial webinars, discount cards 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.