Clinical - Rep, Clinical Records

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 (, 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 Edwards policies and procedures relevant to...

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