ARKRAY USA, Inc.
  • 15-Jun-2018 to 14-Aug-2018 (CST)
  • Science
  • Minneapolis, MN, USA
  • Salary
  • Full Time

Medical, Dental, Group Life Insurance, Voluntary Life Insurance, Disability, 401(k) Plan, Flexible Spending Plans, Tuition Reimbursement, Paid Time Off (PTO) and Holiday Pay


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

ARKRAY is currently seeking a Clinical Scientist to work on clinical and analytical studies related to new and existing ARRKAY products and leading to regulatory and other submissions.

ARKRAY is a leading manufacturer of innovative diagnostic and monitoring products including blood glucose monitors, automated urinalysis systems, A1C systems, clinical chemistry instruments, reagents and consumables. Additionally, ARKRAY has also developed devices for use in such areas as infectious diseases, dental/oral wellness, etc.

Duties and Responsibilities

  • Implement and manage clinical study activities for current and new IVDs and Medical Devices.
  • Work with the team on all clinical study aspects including CRO selection, site selection, PI selection, protocol development, support with IRB activities, participate and monitor the studies, support with data analyses, and study close-out activities.
  • Provide guidance to product development teams on GCP issues for the planning of clinical field investigations to generate the data necessary to support product claims or indications required for regulatory submissions (such as 510k and CLIA Waiver).
  • Initiate and maintain contact with principal investigators, study coordinators and study participants.
  • Prepare and perform evaluative studies/bench studies of current and new ARKRAY products.
  • Travel to field sites to initiate, supervise, monitor and audit clinical studies.
  • Provide technical support and lab training to other members of the Science department as well as to other departments, functioning in a team environment.
  • Support with troubleshooting existing ARKRAY products, processes, and customer complaints. This could include performing laboratory or clinical studies.
  • Perform related duties as assigned by immediate supervisor and other management as required. 

Knowledge and Skills

  • Requires at minimum a BS/BA in any biological science or Medical Technologist degree (or equivalent combination education and/or work experience)
  • 3-4 years progressive clinical study and scientist experience in the IVD, medical device or related field.
  • Clinical study related certification is a plus.
  • Proven experience with analytical and clinical studies is required.
  • Previous experience selecting and managing CRO's is preferable.
  • Proficient in Word, Excel and programming of templates for handling laboratory and clinical data.
  • Ability to travel 30-40% of the time.
  • Ability to work well inter-culturally with representatives from Japan.
  • Ability to successfully pass Motor Vehicle Records and background check.

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

 

ARKRAY USA, Inc.
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