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,