Clinical Trials Representative (eTMF/CTMS)

Job Title: Clinical Trials Representative (eTMF/CTMS)Pay Rate: $27 to $31.22/HRDuration: 12 monthsLocation: Irvine, CA

Our Client is a Global medical device Manufacturer.

We are looking for a Clinical Records RepresentativeSummary:The main function of a clinical records representative is to ensure the 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 supervisionOrganize 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 guidelinesSupport team members during internal and external auditsOther incidental duties: May maintain and track study supplies

Additional Skills:Good computer skills including MS Office Suite, Adobe, and ability to operate general office machineryGood written and verbal communication skills and interpersonal relationship skillsBasic knowledge and understanding of our policies and procedures relevant to clinical study documentationBasic knowledge of EW GDP (Good Document Practice) SOP requirementsAbility to manage confidential information with discretionStrict attention to detailAbility to manage competing priorities in a fast-paced environmentAbility to interact professionally with all team organizational levelsMust be able to work in a team environment, including inter-departmental teamsAbility to Provide feedback in a professional, direct, and tactful manner

Education and Experience:H.S. Diploma or equivalent Required2-4 years of experience