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Rep, Clinical Records

Irvine, CA 92614

Posted: 03/14/2023 Employment Type: Contract Job Category: Other Job Number: 551350 Is job remote?: No Country: United States

Job Description


The main function of a clinical records representative is to 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
  • Support team members during internal and external audits
  • Other incidental duties: May maintain and track study supplies

Additional Skills:
  • Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
  • Good written and verbal communication skills and interpersonal relationship skills
  • Basic knowledge and understanding of Edwards policies and procedures relevant to clinical study documentation
  • Basic 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, including inter-departmental teams
  • Ability to Provide feedback in a professional, direct, and tactful manner

Education and Experience:
  • H.S. Diploma or equivalent Required
  • 2-4 years of experience
26-31 pay rate range
**salary will be commensurate with experience**
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