Job Information
BIOFIRE DEFENSE Clinical Research Scientist in MURRAY, Utah
Clinical Research Scientist
Position Summary
The Clinical Research Scientist is responsible for the initiation and oversight of clinical evaluations in support of BioFire Defense in vitro diagnostic (IVD) products. Their primary responsibility is to develop, lead, and report on clinical performance studies that demonstrate products and devices are functioning in accordance with design and regulatory requirements and specifications. Daily responsibilities will include planning and designing projects, directing and overseeing activities of Clinical Research Associates, data analysis, troubleshooting, budgeting, reporting results and observations, and writing and reviewing study reports and regulatory submission documents. Work is primarily collaborative and requires the ability to effectively and respectfully communicate and coordinate with peers and supervisors.
Other key skills required:
- Excellent interpersonal skills and ability to work with a broad range of clinical personnel (physicians, laboratory directors, laboratory staff, volunteer participants, etc.).
- Ability to travel (up to 30%) to initiate and monitor clinical sites.
- Excellent writing and communication skills.
- Experience with microbiology and molecular biology principles, tools, and techniques
- Experience with PCR and PCR applications
- Knowledge of statistical analysis
- Proficiency with Microsoft Office Suite
- Preferred but not required experience:
- Clinical study administration or management (e.g. electronic data capture system and electronic trial master file development and maintenance)
- Knowledge of Good Clinical Practices
- Knowledge or previous training in Human Subjects Protections
May be required to obtain and maintain a DoD Personnel Security Clearance
Education and Experience
- PhD degree with emphasis in a science, or related field
- At least two years' experience conducting research in an academic or industry environment