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Rep, Clinical Records

2 months ago

Irvine, United States Edwards Lifesciences Full time

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.

This is a great role for anyone who is interested in getting into the clinical research field. As a Clinical Records Representative, you will be responsible for ensuring the accuracy and completeness of our clinical study documents.

**How you will make an impact**:
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
Review clinical data for completeness of study files
May retrieve documents in support of internal and external audits utilizing knowledge of eTMF filing structure
**Other incidental duties**: May collate new study materials, create study binders, patient recruitment materials, and arrange shipment of materials to clinical sites

**What you will need (required)**:
High School Diploma or equivalent
2 years of previous related experience in regulatory documentation for clinical studies

**What else we look for (preferred)**:
Bachelor’s Degree in related field

**Additional skills**:
Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
Experience with TMF preferred
Good written and verbal communication skills and interpersonal relationship skills
Good knowledge and understanding of Edwards policies, SOPs, and domestic medical device regulatory guidelines relevant to clinical study documentation
Good knowledge of EW GDP (Good Document Practice) SOP requirements
Strict attention to detail
Ability to manage confidential information with discretion
Ability to manage competing priorities in a fast paced environment
Ability to interact professionally with all team organizational levels
Must be able to work in a team environment under mínimal supervision
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

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 California, the base pay range for this position is $51,000 to $67,000(highly experienced).

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