Investigator Initiated Trial Protocol
Request help from the IIT PDU using the
online project request form.
The purpose of the IIT PDU is to identify and promote high quality therapeutic-intent IITs and assist with study development utilizing regulatory, protocol writing, statistical, and clinical research associate expertise. The IIT PDU staff consists of a senior clinical
research associate, a clinical research nurse, a regulatory associate, an OnCore information technology specialist, and a member of the Biostatistics Shared Resource Facility. Investigators may request IIT PDU support directly or be referred by their CCART, research
program leaders, the Protocol Review and Monitoring Committee (PRMC), or the MCC Director. The intent of IIT PDU support is always to improve the likelihood of success and meaningful discovery.
Dr. Susanne M. Arnold, MD, Professor of Medicine and Radiation Medicine, Markey Cancer Center Associate Director for Clinical Translation
Telephone: (859) 323-8043
Dr. Arnold, the Associate Director for Clinical Translation at MCC, has major research interests in lung cancer, head and neck cancer, experimental therapeutics and population-based cancer research. She has written and conducted over 10 original clinical trials in lung and head and neck cancer and has participated in numerous cooperative group trials. Dr. Arnold has also authored multiple investigator-initiated clinical trials in lung cancer. Her current research portfolio includes a large research grant from the Department of Defense grant to study the relationship of trace elements to lung cancer in Appalachian Kentucky.
Courtney, BS, CCRP, Director of Clinical Research Operations
Mr. Courtney has 16 years of experience in the health care industry and nine years in clinical cancer research. Before becoming the Associate Administrative Director for the clinical cancer research unit at Mayo Clinic (Florida), he was the lead CRA for neuro-oncology, GI,
melanoma, and sarcoma studies. He is a national auditor for SWOG. Mr. Courtney manages all daily operation of the CRDM SRF, and under his leadership, new policies and procedures have been implemented to ensure operational efficiency in support of quality clinical cancer trials.
Bryan Baseheart, BA, CCRA, OnCore Data Manager
Telephone: (859) 323-3604
Mr. Baseheart is responsible for OnCore data management, including data quality control, training, eCRF creation, eCRF data monitoring (including source data verification), ClinicalTrials.gov, and Clinical Trial Reporting Program support. He also supports DSMC and Audit Committee data queries. Mr. Baseheart
has over 16 years of experience in academic and private clinical research organizations.
Jeri Reynolds, BSN, CCRC, Clinical Manager, Phase I
Telephone: (859) 323-8528
Ms. Reynolds has 25 years of experience as a CRN, and previously served as the Administrative Director and Senior Nurse Clinician for UK’s Division of Digestive Diseases Clinical Research Department for 17 years. She has been instrumental in establishing and coordinating the Early Therapeutic Clinical
Specimen Processing Laboratory. She is a member of the UK Investigational Drug Service Advisory Committee, Early Therapeutics CCART, and IIT PDU support team. She assists in training and mentoring new and junior-level CRAs.
Colleen Thomas, Chief Financial Specialist
Telephone: (859) 323-9983
Ms. Thomas has over 20 years experience in accounting and business leadership. Previously, she served as the Senior Associate for Finance, Membership and Administration for the Omicron Delta Kappa National Headquarters. She is experienced in budget development and negotiations, pre- and post-award management
of grants, and operations of the budget/finance office.