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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


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 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**

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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