Salt Lake City, UT, 84190, USA
17 hours ago
Clinical Studies Operations Specalist
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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