Job Description

Irvine, CA - Onsite

10 month contract

Pay: $27hr

PART TIME - 20 hours weekly, flexible hours

MUST have experience with Veeva Vault

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 policies and procedures relevant to clinical study documentation

• Basic knowledge of 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

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