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 Edwards 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