Clinical Systems Associate (FHI Clinical)

Tags: Law Environment
  • Added Date: Wednesday, 12 April 2023
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Summary of the Position:

The Clinical Systems Associate will provide day-to-day technical and administrative support for various Clinical Systems, including the Clinical Trial Management System (CTMS), and the electronic Trial Master File (eTMF) as well as components of the Quality Management System. This position includes supporting end users of the systems on general needs, entering subject visit data and site information, delivering, and participating in training new users on the systems, and resolving questions/issues arising in a timely manner. Through the application of systems and processes, the role will also help FHI Clinical become more efficient in utilizing automation that will promote transparency for the work that we do.

Note: It is preferred applicants have reliable internet/Wifi though we have dedicated workspace in Monrovia.

Essential Functions:

  • Handles day-to-day operations and system administration for a small portfolio of clinical applications. Assists manager with supporting current users of the applications and may include Provisioning new users. Troubleshoots user access issues. Assists projects for clinical applications as needed including but not limited to creation of Accounts/Contacts within systems, entering subjects and subject visit dates. May include assisting with the planning and execution of interoperability activities of two or more systems. Collaborates with key stakeholders, to develop and maintain manuals, quick reference guides, training materials, templates procedures, and other supportive procedural documents associated with Clinical managed systems. Manages (including tracking) issues noted by system users, including those requiring submission to Clinical system vendor helpdesk. In regard to the Quality Management System (QMS)

  • Maintains general role specific curriculums for Clinical Operations functional areas.

  • Assists with creating the placeholders for project specific training curriculums.

  • With the guidance of clinical operations functional leads, assigns training to clinical operations team members.

  • May confirm user access to QMS accounts.

    Regarding the eTMF system (responsible for, but not limited to):

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