Senior Specialist, Clinical Research Monitoring THV; Mountain

Senior Specialist, Clinical Research Monitoring THV (Mountain, Central US)

Imagine how your ideas and expertise can change a patient’s life. Edwards Lifesciences generates extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need.

In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis and aortic regurgitation impact millions of people globally, yet it often remains under‑diagnosed and under‑treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life‑changing solution, offering heart valve replacement without the need for open heart surgery.

Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by rigorous clinical evidence.

• Field monitoring of studies and data collection for clinical trials, assessing all documentation, reports, records, transcripts and exam results for consistency with the case report form and ensuring study subject documentation meets study parameters, and monitoring safety in accordance with protocols, GCP and regulatory requirements.
• Develop and deliver technical training on GCPs, protocols, database usage, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation and on‑board new employees, acting as a mentor to junior staff.
• Provide oversight and insights into trial activities (trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators, sponsor management and leadership staff, including institutional review boards and contract and training teams, and develop process improvements.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms, and participate in team projects.
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to field sites and through final disposition.
• Verify trial data, maintain appropriate regulatory documents both internally and externally, audit site documentation to ensure it is complete, and ensure source documentation is properly recorded.
• Edit and amend informed consent documents.

• Bachelor’s degree and a minimum of 5 years of experience in clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory compliance, or equivalent as defined by Edwards.
• Experience working in a regulated industry.
• Experience with electronic data capture systems.
• Ability to travel up to 75% for clinical site visits.

• Knowledge of cardiovascular physiology and structural heart anatomy.
• Previous medical device clinical research experience in cardiology.
• Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification).
• Prior clinical research experience with Class III medical devices, including PMA, IDE and 510(k).
• Excellent written and verbal communication, presentation, interpersonal and analytical skills.

Edwards is an Equal Opportunity/Affirmative Action employer including protected veterans and individuals with disabilities.

COVID Vaccination Requirement:
Edwards is committed to protecting our vulnerable patients and healthcare providers. All patient‑facing and in‑hospital positions require COVID‑19 vaccination. If hired into a covered role, you will be required to submit proof of vaccination, unless you request and are granted a medical or religious accommodation for exemption. This requirement does not apply in locations where it is prohibited by law.