Clinical Records Representative, Transcatheter Heart Valve Unit, Irvine, Ca Based

Edwards Lifesciences
Irvine, CA Full Time
POSTED ON 2/7/2022 CLOSED ON 4/30/2022

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.

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