Clinical Studies Operations Specalist
BioFire Diagnostics, LLC.
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
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