Clinical Research Scientist I

Description

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).

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%.