Clinical Records Representative
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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As the Clinical Records Representative, you will play a key role in ensuring the accuracy, completeness, and proper management of documentation that supports our clinical studies. This is a hybrid position combining remote work with onsite collaboration. The selected candidate must live within a reasonable commuting distance of our Irvine Corporate location and be available for required onsite days. 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 include collating new study materials, create study binders, and patient recruitment materials, and coordinating the shipment of materials to clinical sites.
Requirements
- H.S. Diploma or equivalent
- 2 years of previous related work experience
Nice To Haves
- 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.
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.
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.
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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
