The Clinical and Translational Science Institute (CTSI) has hired Kelly McCormick, MBA, as Regulatory Manager. In this new role, Kelly will oversee CTSI’s regulatory services and provide guidance and oversight on research compliance for the Academic Health Center (AHC).
“One of the many ways CTSI supports University investigators is by providing access to specialists that can help investigators navigate and adhere to research regulations and requirements,” says Timothy Schacker, MD, CTSI’s Clinical Translational Research Services Director. “Kelly has the experience, skills, and expertise that will help enable us to better serve investigators and ensure research compliance.”
Clinical research and regulatory expertise
Kelly brings 10 years of administrative and project management experience in the clinical research and healthcare fields.
Most recently, she managed HealthPartners’ Research Subject Protection Program. Kelly oversaw all areas of the program, including continuing education, quality assurance and post-approval monitoring, and regulatory oversight.
In her role, she also successfully combined the Institutional Review Board (IRB) offices at HealthPartners and Park Nicollet Health Services into one centrally located program.
She has also held positions relating to clinical research and regulatory affairs at Aurora Health Care, the Medical College of Wisconsin, and Covance Laboratories, Inc.
Kelly received a bachelor of science degree from the University of Wisconsin–Green Bay, and has a Master of Business Administration (MBA) degree from the University of Phoenix's online program in Madison, Wisconsin.
Regulatory leadership for clinical and translational research
As Regulatory Manager, Kelly will oversee the regulatory services that CTSI provides to University of Minnesota investigators, including clinical trial monitoring, Investigational New Drug (IND) and Investigational Device Exemption (IDE) application assistance, and ClinicalTrials.gov compliance.
Kelly will work to ensure that research follows good clinical practices (GCP) and standard operating procedures (SOPs), and is compliant with Food and Drug Administration (FDA) and IRB guidelines.
Supporting AHC regulatory affairs
In addition, Kelly will represent regulatory affairs for the AHC and collaborate across departments, CTSI functions, the Office of the Vice President for Research (OVPR), and external organizations to ensure appropriate regulatory oversight and compliance for the University’s clinical and translational research.
This new part of the position was requested by the Dean of the Medical School and Vice President for Health Sciences. The search panel spent 1½ years finding the right candidate and Dean Tolar affirmed the need for additional regulatory support.
Kelly will report to Lisa Johnson, CTSI's Clinical Translational Research Services Associate Director.