Kathy Scott, BS, is Principal Scientist, Clinical Research, for Cardinal Health Regulatory Sciences.
Scott has been in the drug development industry for 28 years and has held leadership roles in clinical trial management and clinical operations. She has extensive experience with the design and implementation of clinical development plans for research programs in Phases 1 to 3.
Prior to joining Cardinal Health in 2013, Scott managed the Research and Development (R&D) Document Control Center at Marion Laboratories and was responsible for the secure and systematic processing, database indexing and retrieval, as well as the reporting and submission compilation of all R&D-generated document collections. She joined the clinical research team at Marion Laboratories in 1992, where she began as a clinical study monitor and eventually served as Manager, Clinical Operations, and as a clinical research functional representative for project development teams. Scott led the operational aspects of clinical study conduct programs, including protocol development, CRO contracting and management, clinical trial oversight, site selection and qualification, clinical site monitoring, database finalization and report writing.
In 1999, Scott joined the SMO division of Radiant Research as Site Director, where she managed the daily clinic operations, clinical trial management and strategic growth of a research-dedicated clinic that was staffed with 19 researchers, including nine study coordinators, two medical directors and eight support personnel. In 2007, she transitioned into the CRO division of Radiant, where she served as Senior Project Manager and was responsible for clinical trial oversight. In 2009, Scott joined a pharmaceutical and medical device company as Manager, Clinical Development, where she managed the outsourcing, oversight and monitoring of clinical trials for multiple development programs.
Scott received a bachelor’s degree in biology from Pittsburg State University.