Clinical Records Representative

3 weeks ago


Irvine, United States Planet Pharma Full time

Summary:

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 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
  • 5-7 years of experience


Pay Rate Range: $28-31/Hr *Salary will be Commensurate with Experience


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