Job Posting for Clinical Records Representative, Transcatheter Heart Valve Unit, Irvine, Ca Based at Edwards Lifesciences
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
The Clinical Records Representative will ensure accuracy and completeness of documents for clinical studies
Key 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 collate new study materials, create study binders, patient recruitment materials, and arrange shipment of materials to clinical sites
Education and Experience:
H.S. Diploma or equivalent Required
Bachelor's Degree Preferred
2 years Required
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 and SOP, and domestic medical device regulatory guidelines relevant to clinical study documentation
Good knowledge of EW GDP (Good Document Practice) SOP requirements
Ability to manage confidential information with discretion
Strict attention to detail
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
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
Salary.com Estimation for Clinical Records Representative, Transcatheter Heart Valve Unit, Irvine, Ca Based in Irvine, CA
$135,800 to $189,148
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