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

Imagine how your ideas and expertise can change a patients 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 youll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients 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 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. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How youll make an impact:

• 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 regulatory requirements

• Develop and deliver technical training on GCPs protocols database compliance device accountability adverse event reporting study investigation protocols amendments regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees

• 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 sponsor management and leadership staff including Institutional Review Boards/Ethics Committees/Research Ethics Boards Contract and Training developing process improvements

• Contribute to the development of clinical protocols informed consent forms and case report forms. Also contribute to 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 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

• Edit/amend informed consent documents
  

What youll need (Required):

• Bachelors Degree and a minimum of 5 years of work experience in clinical research monitoring with a strong focus on quality assurance quality control and regulatory compliance or equivalent based on Edwards criteria

• Experience working in a regulated industry

• Experience with electronic data capture

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

What else we look for (Preferred):

• 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 skills presentation skills interpersonal skills and analytical skills

Aligning our overall business objectives with performance we offer competitive salaries performance-based incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For Colorado (CO) the base pay range for this position is $106000 to $149000 (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.

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 the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.