• Clinical Studies Operations Specialist

    BioFire Diagnostics, LLC. (Salt Lake City, UT)


    Support the conduct of clinical studies related as per clinical project timelines. Act as a liaison person between Clinical Study sites and other internal departments. Maintain the clinical study related documentation ahead, during and after the completion of the clinical study; work collaboratively with the Clinical Study Scientist and Clinical Research Associate, in conjunction with the clinical sites.

     

    This role is based in Salt Lake City and is not a remote position.

    Job Responsibilities:

    + Assist in study agreement preparation with legal and other functions along with the concerned authorities at the clinical study sites.

    + Prepare templates for budget estimates and facilitates communication between internal and external partners during contract and budget phases of the clinical study project.

    + Manage the clinical sites referencing, purchase orders, invoicing processes, regular accruals.

    + Assist with supply purchasing and support clinical research associate with supply management

    + Prepare the documentation package for the purpose of the submission to Independent Ethic Committee or Independent Review Board, as per respective expectations

    + Report any clinical study related relevant information to competent authorities (EUDAMED, Sunshine act...)

    + Monitor and report the progress of the above activities to the Clinical Scientist or Clinical Research Associate

    + Own the above site administrative support process

    + Prepare the on-site documentation as per Good Clinical Practices (Investigator Study File - ISF)

    + Handle any study paperwork or electronic documentation generated during the progress of the clinical study

    + Structure, prepare and regularly feed the electronic clinical trial master file, including all the study documentation and main project deliverables.

    + Own the above clinical trial related documentation process

    Position Requirements:

    • Associate Degree required

    • 1+ years of clinical trial experience

    • Skills in administrative tools (Office 365 , Teams, Outlook, …), WebApp

    • Team spirit and collaborative work among peers and with department members

    • Excellent sense of customer service

    • Good sense of adaptation, great organizational, ability to prioritize, rigor, methodical approach