Kristin has over 25 years of experience using in vitro diagnostic (IVD) instruments in a lab setting, managing clinical studies, managing clinical research teams and assisting with regulatory and quality concerns. She has brought several products from concept to commercialization, including point-of-care and automated assay platforms for use in several therapeutic areas. Her expertise spans the globe as she has helped to launch products in the US, Canada, Europe and China.
Prior to NAMSA, Kristin spent 18 years at Beckman Coulter, where she received numerous promotions resulting in Manager, Clinical Affairs in the Immunoassay Business Unit. Her previous Beckman Coulter positions include Clinical Studies Scientist, Senior Clinical Studies Scientist and Staff Clinical Studies Scientist. Before that, she interacted with IVD products daily as a laboratory technician for two major healthcare systems.
Kristin has acquired several industry certifications such as Clinical Trial Management from the University of Chicago (Chicago, IL), RAPS Dual Certificate in Regulatory Affairs for Medical Devices and Pharmaceuticals, AACC Certificate in Fundamentals of Molecular Pathology, ISO 14155 (2011) – Clinical Investigation of Medical Devices for Human Subjects, 21 CFR Parts 11, 50, 56, 812, 814 and 820, as well as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and ICH E6. Kristin is a member of the Association of Clinical Research Professionals (ACRP).
- Managing global clinical trials, including protocol writing, site identification, site qualification, site initiation visits, interim monitoring, close-out visits, Institutional Review Board (IRB) approval, site budget/contracting and electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) implementation
- Providing strategic clinical consulting on clinical trial designs, clinical performance expectations from regulatory bodies, commercialization and site performance