Imagine how your ideas and expertise can change a patient’s life. We generate 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 impacts 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 for patients by 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 clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

We are searching for a Senior Clinical Research Monitor to join Edwards Transcatheter Pulmonic Field Monitoring team. As the Senior Clinical Research Monitor, you will ensure trial patients’ safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. The ideal candidate will reside in the Western region.

How you'll make an impact:

• Perform field monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts, and exam results for consistency with case report forms.

• Determine if clinical trial/study subject documentation aligns with the study hypothesis and monitor clinical trial/study safety in accordance with protocols, Good Clinical Practices (GCP), and regulatory requirements.

• Develop and deliver technical training on GCPs, protocols, databases, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements.

• Train and mentor new or junior employees on trial and study-related activities.

• Provide oversight and insights into trial activities, such as trends in protocol compliance, enrollment, monitoring deviations, and data quality, to principal investigators, support staff, and study sponsor management and leadership. Work with Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contracts, and Training to 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 the field sites and through final disposition.

• Verify trial/study data, maintain appropriate regulatory documents both internally and externally, and audit to ensure the site has the necessary regulatory documentation to conduct the trial/study.

• Ensure source documentation is properly recorded and edit/amend informed consent documents as needed.

• Perform other incidental duties as assigned.

What you'll need (Required):

• Bachelor's Degree in related field or equivalent

• 5 years of relative work experience in clinical research field monitoring, with a strong focus on quality assurance, quality control, and regulatory compliance

• Experience working in a regulated industry

• Experience with electronic data capture

• Ability to travel up to 75% for clinical site visits

• Covid Vaccination

What else we look for (preferred):

• Risk Based Monitoring experience

• Experience with structural heart indications, including leading pulmonic-related studies

• Knowledge of cardiovascular physiology and structural heart anatomy

• Extensive clinical research experience in cardiology within the medical device industry

• Exposure/ understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

• Technical writing skills (protocols, CRF development, study tools)

• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills

• Demonstrated problem-solving and critical thinking skills

• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery

• Ability to communicate and relate well with key opinion leaders and clinical personnel

• Experience with training junior members of the team

• Clinical Research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)

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

For California (CA) the base pay range for this position is $106,000 to $140,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.