Senior Clinical Research Coordinator
3 weeks ago
Client: Major Medical Device Client
Duration: 9+ months
Location: Irvine, CA
Actual Title: Senior Clinical Records Specialist
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 Client policies and procedures relevant to clinical study documentation
• Basic knowledge of Client 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
• 5-7 years of experience
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