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TalentBurst, an Inc 5000 company

Clinical Records Representative

TalentBurst, an Inc 5000 company, Irvine, California, United States, 92713

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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