Clinical Studies Operations Specalist

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

Job summary

Join a forward-thinking company as a Clinical Study Coordinator in Salt Lake City, where you will play a crucial role in supporting clinical studies. This position involves liaising between clinical study sites and internal departments, ensuring that all documentation is meticulously maintained throughout the study lifecycle. You will assist with budget preparation, manage site references, and facilitate communication with partners. If you have a passion for clinical research and possess strong organizational and administrative skills, this role offers an exciting opportunity to contribute to impactful healthcare advancements.

Qualifications

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

Responsibilities

• Assist in study agreement preparation and budget estimates.
• Maintain clinical study documentation and support site management.

Skills

Administrative Skills

Customer Service

Organizational Skills

Team 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, ability to prioritize, rigor, methodical approach