Clinical Studies Operations Specalist

BioFire Diagnostics; Salt Lake City (UT); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Clinical Study Coordinator to support clinical studies in Salt Lake City. This role involves acting as a liaison between clinical study sites and internal departments, ensuring smooth project timelines and documentation management. The ideal candidate will have an Associate Degree and at least one year of clinical trial experience, along with strong administrative skills and a collaborative spirit. Join a dynamic team where your contributions will directly impact the success of clinical research projects, making a difference in the healthcare landscape.

Qualifications

• 1+ years of clinical trial experience required.
• Strong skills in administrative tools and excellent customer service.

Responsibilities

• Assist in study agreement preparation and manage clinical site processes.
• Prepare documentation for ethics committee submissions and monitor study progress.

Skills

Administrative Skills

Customer Service

Organizational Skills

Collaboration

Education

Associate Degree

Tools

Office 365

Teams

Outlook

WebApp

Job 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:

• 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 skills, ability to prioritize, rigor, methodical approach.