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Clinical Research Scientist I

This job posting is no longer active.

Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Clinical Affairs

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A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.


Job Summary:

The Clinical Research Scientist 1’s primary responsibility is to develop and lead clinical studies that demonstrate an in vitro diagnostic (IVD) product meets the regulatory requirements. Specifically, the Clinical Research Scientist 1, under the supervision of the Associate Director of Clinical Affairs, is responsible for planning, designing, overseeing, and writing study reports for clinical studies within the Clinical Affairs team that will be used to support the regulatory submissions. The studies will mainly be conducted by external contractors and may also include testing at BioFire.

Essential Job Duties and Responsibilities:

  1. Performs all work in compliance with company policy and within the guidelines of BioFire’s Quality System.
  2. Maintain current knowledge of FDA requirements for clinical studies and FDA expectations for establishing clinical performance of diagnostic products.
  3. Contribute to pre-submission documents for FDA feedback on clinical study plans.
  4. Develops plans for clinical validation of in vitro diagnostic (IVD) reagent test kits under general guidance from the Associate Director of Clinical Affairs (e.g. study protocols, laboratory test procedures, Case Report Forms (CRF), IRB submissions)
  5. Writes study reports that will be used to support regulatory submissions.
  6. Oversees monitoring of clinical trial sites to ensure that the study is conducted according to the protocol and to identify technical issues. Additionally, ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements
  7. Identify and establish collaborations with appropriate clinical laboratories to perform off-site specimen collection and testing during the study.
  8. Maintains broad knowledge of state-of-the-art principles and theories.
  9. Makes contributions to literature and conferences as well as grant/proposal writing and patent applications, as needed.
  10. Advises management about scientific issues related to studies in support of regulatory submissions.
  11. Collaborates with other scientists and personnel in various company departments to resolve technical issues.
  12. Uses professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways.
  13. Ensures that laboratory notebooks and study paperwork (as applicable) for assigned projects/experiments are maintained in accordance with BioFire’s Employment Handbook.
  14. Participate in writing of final regulatory documents (e.g. 510K Pre-Market Submission to US FDA)
  15. Maintains current knowledge of IHC/Good Clinical Practices as well as international regulations and expectations for clinical performance evaluations as needed.
  16. Maintains current Human Subjects Protections training through an accredited program (e.g. CITI).

Supplemental Data:

  1. This position requires excellent written and oral communication skills.
  2. Excellent interpersonal skills and the ability work with a wide variety of people (physicians, laboratory directors, laboratory staff , etc) involved in conducting the clinical studies.
  3. The ability to work closely with Associate Director of Clinical Affairs to identify and communicate areas of technical, schedule, and budget risk.
  4. Excellent organizational skills are essential.
  5. Some driving within Salt Lake County may be required. Must provide own transportation.
  6. Domestic and international travel required – up to 30%.

Training and Education:

Requires a PhD in scientific discipline or equivalent; may also include exceptional non-PhDs with demonstrated capabilities.


PhD with no additional experience or master’s with at least 5 year of experience. Postdoc or prior industry experience preferred. Prior experience with human subjects research desired.

Knoweldge, Skills, and Abilities:

Strong written and oral communication skills. Basic statistical techniques.

Physical Requirements:

May be required to lift 60 lbs. Regular and consistent attendance.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux 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.,,, 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 or contact us at [email protected].

BioMérieux 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 BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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