Rep, Clinical Records
1442 Alton Parkway Irvine, CA 92606 US
Job Description
Target PR Range: 18-28/hr
*Depending on experience
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 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
Education and Experience:
- H.S. Diploma or equivalent Required
- 2-4 years of experience
Skills: Ability to Work with Others Detail oriented Team Player
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