Clinical Records Representative Job at TalentBurst, an Inc 5000 company, Irvine, CA

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  • TalentBurst, an Inc 5000 company
  • Irvine, CA

Job Description

Position: Representative, Clinical Records, Req#: 12839-1

Location: Irvine, CA (100% onsite only)

Duration: 9+ Months Contract (Part-Time job, 20 hours per week, Part-time flexible hours (PST), full-time onsite.)

Does your team use any specific technology/software you want us to look out for?

MUST have experience with Veeva Vault

Previous work and knowledge of clinical documents

Job Description:

The main function of a clinical records representative is to ensure accuracy and completeness of documents for clinical studies.

Education and Experience:

  • H.S. Diploma or equivalent required
  • 2-4 years of experience
  • MUST be experienced with Veeva Vault
  • Previous work and knowledge of clinical documents
  • Reviewed and filed clinical information/documents in Veeva in the past
  • High attention to detail

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

Job Tags

Full time, Contract work, Part time, Flexible hours,

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