Clinical Studies Operations Specialist

bioMerieux Inc.; Salt Lake City (UT); On-site; USD 45,000 - 70,000; Full time

Job summary

Join a forward-thinking company as a Clinical Studies Operations Specialist, where you will support clinical studies and act as a liaison between study sites and internal departments. This role emphasizes collaboration, organization, and customer service, ensuring that clinical projects run smoothly and efficiently. With a strong focus on improving patient health and safety, you will play a vital role in maintaining clinical study documentation and preparing necessary reports. If you're passionate about making a difference in the field of diagnostics, this is the perfect opportunity for you.

Qualifications

• 1+ years of clinical trial experience required.
• Proficient in administrative tools including Office 365 and Teams.
• Strong organizational skills and ability to prioritize tasks.

Responsibilities

• Assist in study agreement preparation with legal and clinical study sites.
• Manage clinical sites referencing, purchase orders, and invoicing.
• Prepare documentation for submission to ethics committees.

Skills

Administrative Tools (Office 365, Teams, Outlook)

Clinical Trial Experience

Customer Service

Organizational Skills

Team Collaboration

Education

Associate Degree

Job description

Clinical Studies Operations Specialist

Location: Salt Lake City, UT, United States

Position Type: Unfixed Term

Job Function: Clinical Affairs

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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

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

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [e-mail].

BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at [phone], by email at [e-mail], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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