Senior Clinical Records Representative

Edwards Lifesciences • Irvine, CA

81d • $60,000 - $80,000

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 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.

Requirements

• High School Diploma or equivalent
• 4 years of previous related experience

Nice To Haves

• Bachelor’s Degree in related field
• Previous work experience with regulatory documentation for clinical studies

Responsibilities

• Review and ensure accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision
• Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines
• Perform quality checks and escalate issues or remediations to management
• Provide training and knowledge transfer to team members
• Review clinical data for completeness of study files
• Retrieve documents in support of internal and external audits utilizing knowledge of eTMF filing structure
• May oversee vendor study training (e.g., CRO, Echo Core Lab, DSMB/CEC)
• Collate new study materials, create study binders, patient recruitment materials, and arrange shipment of materials to clinical sites

Benefits

• Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities
• COVID-19 vaccination requirement for patient-facing and in-hospital positions

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees