This position will report to the Chief Technology Officer.

The CRD will have overall ownership of the clinical studies performed by and for Next Science.  This position will be responsible for study placement, clinician selection, and patient recruitment, with oversite to the Clinical Research Group.  This individual will also be tasked with presenting scientific data to commercial partners and to clinicians.

Experience

  • M.S. in a STEM field (medical preferred)
    • Preferred degree in clinical research
  • Prior experience in performance of clinical research
    • Preferred experience as a clinical research coordinator
    • Preferred experience with both medical device and drug trials

Skills

  • Fluent English Business communication skills
  • Flexible with well-developed critical thinking skill
  • Must be comfortable in fast paced environment
  • Able to accommodate and adapt to frequent change
  • Understanding of technical medical terminology
  • Comfortable and able to present scientific and clinical data to clinicians, customers, and partners

Responsibilities

  • Management of the clinical research team, focusing on driving clinical trials to rapid enrollment and timely completion. Team responsibilities include:
    • Drafting clinical trial protocols, reports, and submissions for publication
    • Determination of study costs and timing
    • Preparation of trial-related paperwork
    • Coordination of sample evaluation with third-party laboratories
    • Data collection and coordination
    • Coordination of test material delivery to investigation sites
    • Reporting of study progress to management
    • Preparation of advertising for recruitment
    • Monitoring of enrollment status
    • Adverse event reporting
    • Creation and monitoring of study timelines
    • Adherence to the Next Science quality system
  • Work closely with marketing and business development to plan and inform the external, customer-facing clinical educational material, such as publications, conference presentations, symposia, study group and development of scientific advisory boards
  • Works on regulatory efforts to write/review FDA facing documents including correspondence, presentations, analyses, clinical trial planning and execution
  • Responsible for developing and maintaining relationships with clinical thought-leaders in relevant fields (e.g. Wound care, surgical infection, infection disease)
  • Oversees all clinical aspects of the product development process, including planning clinical trials needed to validate the product from regulatory and marketing standpoints
  • Presentations of scientific and clinical data to clinical groups, customers, and commercial partners.

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