Edwards Lifesciences is seeking a Senior Clinical Research Monitor to safeguard patient safety by ensuring clinical trials are conducted ethically and in full regulatory compliance. In this role, you will be instrumental in maintaining data accuracy and protocol adherence, while also mentoring colleagues and contributing to protocol development.

What You'll Do

Conduct field monitoring for clinical trials, assessing data documentation and reports for consistency with case report forms and study parameters.
Monitor clinical trial safety in keeping with protocols, GCP (Good Clinical Practices), and all regulatory requirements.
Develop and deliver technical training on GCPs, protocols, database use, compliance, and adverse event reporting.
Train and proctor new employees on trial-related activities and act as a mentor to junior staff.
Provide oversight and insights on trial trends (e.g., enrollment, data quality) to principal investigators and leadership.
Contribute to the development of clinical protocols, informed consent forms, and case report forms.
Validate investigational device accountability through complete tracking from Edwards to field sites.
Verify trial data and maintain appropriate internal and external regulatory documents.
Edit and amend informed consent documents.

What We're Looking For

Bachelor's Degree in a related field or equivalent.
5+ years of clinical research monitoring experience with a focus on quality assurance, quality control, and regulatory compliance.
Experience working in a regulated industry.
Hands-on experience with electronic data capture systems.
Ability to travel up to 75% for clinical site visits.
Covid Vaccination.

Nice to Have

Knowledge of cardiovascular physiology and structural heart anatomy.
Previous medical device Clinical Research experience in cardiology.
Clinical research certification (e.g., ACRP, SOCRA, Clinical Coordinator/CRA).
Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k).
Excellent written, verbal, presentation, interpersonal, and analytical skills.
Proven expertise in MS Office Suite (Word, Excel, Adobe).
Demonstrated problem-solving and critical thinking skills.
Excellent understanding of cardiovascular anatomy, pathology, and physiology.
Moderate understanding of medical device regulatory requirements, device accountability, and adverse events reporting.
Technical writing skills for protocols, CRF development, and study tools.
Ability to communicate and relate well with key opinion leaders and clinical personnel.