What are the responsibilities and job description for the Clinical Studies Operations Specialist position at bioMérieux?
Description
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 :
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