Senior Specialist, Clinical Research Monitoring THV (West Coast US)

Edwards Lifesciences • San Diego, CA

26d • $106,000 - $149,000

About The Position

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 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. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll 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

Requirements

• Bachelor's 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

Nice To Haves

• 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

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 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level