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
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
Jeri Reynolds, BSN, CCRC, Clinical Manager, Phase I
Telephone: (859) 323-8528
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
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.