Clinical Records Representative - TalentBurst, an Inc 5000 company : Job Details

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.)

More on this position:

What does your group do? Oversees clinical trials for the Surgical BU.

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

Additional Skills:

• Good computer skills including MS Office Suite, Adobe, and the ability to operate general office machinery
• Good written and verbal communication skills and interpersonal relationship skills
• Basic knowledge and understanding of the client's 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

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