Clinical Records Representative (Part-Time)

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 #J-18808-Ljbffr Planet Pharma