Program Director, mHealth Research Core (mHRC) Manager, Trial-CARE Division of The Center for Clinical Studies (CCS)
Katie is the Program Director of the mHealth Research Core (mHRC) and the Manager of the Trial-CARE Division of the Center for Clinical Studies (CCS). She has over 10 years of experience in management (including clinical research management) and program development, and over 5 years of experience leveraging technology to implement clinical interventions and research using digital health solutions. Katie also has expertise in navigating regulatory standards for computerized systems (e.g., HIPAA, GDPR and FDA 21 CFR Part 11). She led the mHRC project efforts related to implementation of eConsent using REDCap at WUSM and the Trial-CARE project efforts to establish the Trial-CARE Part 11 Services Unit. Katie, in collaboration with leadership from the Human Research Quality Assurance (HRQA) Office, started the eConsent and Part 11 workgroup that now meets monthly, bringing together operational leaders from Trial-CARE, the mHRC, the CCS, the Becker Medical Library, the Institute for Informatics (I2), the IRB and HRPO, HRQA, and the Office of the Vice Chancellor for Research (OVCR).