Edwards Lifesciences · 1 day ago
Clinical Records Representative
USA - California – Irvine
Full-time
Hybrid
Entry Level
$53K/yr - $70K/yr
2+ years expEdwards Lifesciences is a company focused on improving patient outcomes through innovative technologies. The Clinical Records Representative will ensure the accuracy and completeness of documentation supporting clinical studies while collaborating with various stakeholders in the clinical affairs team.
BiotechnologyHealth CareMedicalMedical Device
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
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 include collating new study materials, create study binders, and patient recruitment materials, and coordinating the shipment of materials to clinical sites
Qualification
Required
H.S. Diploma or equivalent
2 years of previous related work experience
Preferred
Bachelor's Degree in related field
Experience in preparing and managing regulatory documentation for clinical studies, ensuring compliance with applicable guidelines and protocols
Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
Experience with TMF
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 minimal supervision
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Andrew Greene
Vice President, Strategy
Recent News
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
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