Clinical Records Representative (Part-Time)

Planet Pharma; Irvine (CA); On-site; USD 37,195; Part time

Job summary

A staffing firm in California is seeking a part-time Clinical Records Representative to ensure the accuracy of clinical study documents. The ideal candidate will have experience with Veeva Vault, strong attention to detail, and good communication skills. This role is essential for maintaining compliance and supporting audit processes in clinical studies. The position offers flexible hours and a pay rate of $27/hour.

Qualifications

• MUST have experience with Veeva Vault.
• 2-4 years of experience in clinical documentation.
• Ability to interact professionally with all team organizational levels.

Responsibilities

• Review and ensure accuracy and completeness of clinical study documents.
• Organize and archive documents in eTMF/CTMS.
• Support team members during audits.

Skills

Good computer skills

Written and verbal communication skills

Attention to detail

Ability to manage confidential information

Education

H.S. Diploma or equivalent

Tools

MS Office Suite

Adobe

Job description

Clinical Records Representative (Part-Time)

Irvine, CA - Onsite • 10 month contract • Pay: $27/hr • PART TIME - 20 hours weekly, flexible hours • MUST have experience with Veeva Vault

Overview

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

Seniority level

• Associate

Employment type

• Part-time

Job function

• Administrative

Industries

• Staffing and Recruiting