Kathi Durdon, MA, CCRP

Experience

• 

  State University of New York Upstate Medical University

  May 1999 - Nov 2005

  Director, Clinical Trials Office

  Business development of SUNY Upstate researchers to industry to take advantage of potential research opportunities. Educational advocate for clinical research study coordinators and associates within academic medical institution. Created budget and contract development and negotiation process to include professional fee and administrative fee structure. Facilitated site qualification visits.

• 

  Welch Allyn

  Oct 2005 - May 2015

  Manager of Clinical Operations

  Develop, strategize and manage GCP compliance, clinical investigation, human factors usability and post-market surveillance initiatives and infrastructure. Manager for senior-level clinical research associates, serve as mentor and operational lead for Clinical Affairs team. Create and promote standard operating procedures/work instructions to provide quality and consistent performance with emphasis on Lean and risk-based approach. Promote access to or personally deliver resources, consultation and training to ensure scope, goals, budget and schedule of projects are met. Voting member within AAMI Human Factors and Clinical Investigation Committees to provide medical device industry representation in applicable Standards and guidance development. Complete clinical evaluation reports for product technical files and other clinical investigation data reporting needs for global medical device company. Show less

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  CNY Biotech Accelerator,Upstate Medical University

  May 2015 - now

  Promotion to Executive Director to include workforce and business development initiatives while also directing the operations of CNY Biotech Accelerator. This includes management of the CNYBAC Medical Device Innovation Challenge and supporting several biotech-related innovation initiatives such as the NEXT Innovation Conference (www.next-syr.com). Continue to work collaboratively with ecosystem partners to include: CenterState CEO, MedTech, Business Incubator Association of NYS, Syracuse COE, Innovation Law Center at Syracuse University, Kingston Syracuse Pathway, Syracuse University Blackstone LaunchPad, Upstate Venture Connect and many others. Show less

  • Executive Director

    Jan 2019 - now

  • Director of Operations

    May 2015 - Dec 2018