Clinical Research Associate

Arkray Usa, Inc. Minneapolis , MN 55439

Posted 1 week ago

Be involved with a company that is changing the lives of people across the globe.

This position is responsible for supporting Blood Glucose Monitoring (BGM) and other ARKRAY diagnostic chemistry products. Support ARKRAY laboratory and Point of Care IVD instruments and reagents. When necessary coordinate and select clinical sites and oversee the clinical research process either in-house or with external resources.

Duties and Responsibilities

  • Design and write protocols/procedures to support current and new Glucose Monitoring (BGM) and other ARKRAY diagnostic chemistry products and processes. This includes data analysis/interpretation and writing of reports.

  • Perform evaluative studies/bench studies of current ARKRAY diagnostic products, new products and competitive products for institutional use/knowledge or to gain regulatory approval (510k and CLIA Waiver).

  • Coordinate/manage or assist with both internal and external clinical studies to support existing and new ARKRAY products. This could include the finding of sites, preparation and managing of all paperwork, contracts, training, monitoring, data verification and reports.

  • Troubleshoot existing diagnostic products, processes, and customer complaints. This could include the performance of laboratory or clinical studies.

  • Supply technical support and lab training to other members of the Science and Engineering department as well as to other departments, functioning in a team environment.

  • Perform related duties as assigned by immediate supervisor and other management as required.

Knowledge and Skills

  • Minimum of a BS in Biochemistry, Chemistry or related discipline, or a BA with 10 years experience. A minor in Math or Statistics is highly desirable.

  • 2+ years experience in the medical device industry, preferably in dry chemistry test strip design and manufacture; AND/OR specifically IVD instruments and reagents designed for Laboratory and Point of Care applications.

  • Proven strong analytical and technical writing skills.

  • Proficient in Word, Excel and programming of templates for handling laboratory and clinical data.

  • When assigned to Laboratory products, ability to travel transpacific in economy class for extended periods (2-4 weeks at a time), up to 10-20% time.

  • Ability to work well inter-culturally with representatives from Japan.

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities are encouraged to apply.


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