Kris Walters, M.S., Ph.D.

Director, Clinical Research Program

Assistant Professor

BS North Carolina State University

MS North Carolina State University

PhD Touro University

Professional Information

Dr. Kris A. Walters is the Director of the UNCW Clinical Research Program; a program one of the first of its kind in the United States.  Dr. Walters manages the Clinical Research Program, as well as teaches courses in the Program as a faculty member.  Dr. Walters' primary research and publications concentrate in the areas of patient consent, comprehension, and compliance.

Prior to her position at UNCW, Dr. Walters was the Associate Director of Clinical Compliance and Quality for AAI Development Services, with responsibility for clinical compliance within the AAI Clinical Trials Division and AAI Phase I/BA/BE Clinic.  She possesses over sixteen years of experience in providing clinical research and compliance guidance both in the U.S. and internationally to clinical investigators, Institutional Review Boards, Contract Research Organizations, Site Management Organizations, and pharmaceutical/biotechnology companies.

Dr. Walters' career also includes working for Burroughs Welcome, Inc., and Amgen, Inc., where at both companies she held positions in clinical compliance and/or regulatory affairs.  Dr. Walters' work in clinical compliance includes assessing the compliance of clinical research sites, companies, and institutional review boards to local, federal, International Conference on Harmonization (ICH), and other applicable regulations and guidelines both domestically and internationally.  She has assisted numerous sites, companies, and institutions through Food and Drug Administration (FDA) and other regulatory inspections.  Dr. Walters is frequently invited to speak at national conferences, seminars, and workshops regarding topics such as FDA inspections, Good Clinical Practices, ICH, standard operating procedures, patient consent, clinical research ethics, drug development, and health literacy.   Her other experience includes clinical project management, monitoring clinical research sites, regulatory submissions, and medical writing.

Dr. Walters obtained a Bachelor of Science degree in Zoology, a Bachelor of Science degree in Biological Sciences, a minor in genetics, and a Masters of Science degree in Management of Biotechnology from North Carolina State University.  She also attended MBA program course at the University of Washington, and obtained her Ph.D. in International Health Science at Touro University.

Contact Information

Office: Friday Annex 158

Phone: (910) 962 - 3640

Email: waltersk@uncw.edu