Clinical Research Scientist II'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 II, 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.
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 the 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 the 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 to work with a wide variety of people (physicians, laboratory directors, laboratory staff, etc) involved in conducting clinical studies.
3. The ability to work closely with the 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.
Experience:
PhD with 3-5 years of relevant experience. MS with at least 8 years for relevant experienceKnowledge, 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