Edwards Lifesciences is growing and our Specialist, Clinical Research Monitoring position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth.
For more details on the acquisition, please visit: https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port
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.

Key Responsibilities:

• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), and relevant regulatory requirements (e.g. ISO 14155).
• Deliver technical training on GCPs, and relevant regulatory requirements (e.g. ISO 14155), protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements.
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study site management including Institutional Review Boards, Contract, and Training, and developing process improvements.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition
• Other incidental duties

Education and Experience:
Bachelor’s Degree in a related field
Minimum 3 years years experience with medical device and/or clinical experience Required

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
• 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
• 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

• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), and relevant regulatory requirements (e.g. ISO 14155).
• Deliver technical training on GCPs, and relevant regulatory requirements (e.g. ISO 14155), protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements.
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study site management including Institutional Review Boards, Contract, and Training, and developing process improvements.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition
• Other incidental dutie