Clinical Research Office: Clinical Protocol and Data Management
The Clinical Research Office (CRO) at Markey Cancer Center offers essential oversight for oncology therapeutic adult clinical trials. Our services encompass centralized regulatory management, reporting, staff supervision, training, and event tracking. Through this infrastructure, the CRO facilitates successful clinical research endeavors at Markey, ensuring compliance with federal, state, and local regulations at every stage of the study.
SERVICES
Clinical operations is responsible for:
- Patient Recruitment and Enrollment: work to identify eligible patients for research studies, ensuring they meet specific criteria outlined in study protocols. We educate patients about the research, obtain informed consent, and enroll participants into trials.
- Study Protocol Adherence: follow study protocols to ensure patient safety and data integrity. We monitor the administration of investigational treatments, ensure patients are scheduled per protocol requirements, monitor patients closely for adverse events, and collect accurate data according to protocol timelines.
- Collaboration and Communication: practice effective communication and collaboration among team members. We regularly meet to discuss patient progress, review study protocols, and address any challenges or concerns that may arise during the research process. We maintain open communication channels with sponsors to address queries and resolve issues promptly.
- Data Management and Analysis: collect and manage data generated during research studies, including but not limited to patient medical records, treatment administration logs, and laboratory results. We work closely with study teams to evaluate treatment efficacy, safety, and any potential side effects.
- Regulatory Compliance: we adhere to strict regulatory guidelines and ethical standards, ensuring all research activities comply with institutional review board (IRB) approvals, Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements.
- Patient Care and Support: we provide compassionate care and support to patients participating in our research studies. Our clinical team monitors patients closely, addressing their concerns, and providing resources for additional support services as needed.
For more information, contact:
Teresa Roberts, RN
Teresa.Roberts@uky.edu
For Precision Medicine, contact:
Jeri Renyolds
jkreyn0@uky.edu
The regulatory unit is responsible for:
- Regulatory study startup and maintenance including IRB application submissions, site and sponsor regulatory documentation management for interventional oncology studies led by Markey Investigators. We have study staff dedicate to study startup and to study maintenance.
- Liaison between study team, internal ancillary groups (e.g. Investigational Drug Service, Biospecimen Procurement and Translational Pathology, etc.), internal committees and study sponsors.
- Maintain audit ready electronic and hard copy records for interventional oncology studies throughout the life of each study and works with team to ensure study records are archived per applicable regulations.
- Maintains clinical trials management system (OnCore) to track regulatory submissions and ensure study documents (e.g. protocols, consents, patient materials, etc.) are available to the study team at all times.
- Collaborate with UK faculty and Investigator Initiated Trials Development Office to activate Investigator Initiated trials including FDA IND/IDE applications and IRB submission development and maintenance.
For more information contact:
Shawn England, Regulatory Manager
Shawn.England@uky.edu
The research finance team assists with both pre- and post-award activities. Our office works with UK’s Clinical Research Support Office (CRSO) for services including coverage analysis, OnCore study calendar creation which is the basis of our budget. Our office prepares study budgets and conducts budget negotiations with industry-sponsored trials. We facilitate contract execution in coordination with the Office of Sponsored Projects (OSPA). We are responsible for clinical research charge review, investigators and ancillary service payment, and monthly account reconciliation.
For more information contact:
Molly Gosky, Finance Manager
Mary.Gosky@uky.edu
For more information contact:
Leigh Anne Faul, PhD, IITO Director
Leighanne.faul@uky.edu
The Multi-Center Research Unit will oversee the management and execution of MCC IIT multi-center studies at NCI Designated and/or Comprehensive Cancer Centers. The MRU works closely with MCC CRO, PMC, and MCC QA offices to provide operational and regulatory support and services. The MRU also act as the central source for coordinating all activities between the internal teams and external teams.
For more information contact:
Cary Osborne, Project Manager for MRU
Cary.Osborne@uky.edu
We ensure all clinical reporting requirements are met such as NCI Clinical Trials Reporting Program (CTRP)
For more information contact:
April Bramel, Compliance Officer
April.Bramel@uky.edu
CLINICAL RESEARCH COMMITTEES
CONTACT INFORMATION
Clinical Research Office Phone: 859-257-3379
Bryan Courtney, Clinical Trials Management Director
bryancourtney@uky.edu
Whitney Cunningham, Clinical Trials Management Manager
Whitney.cunningham@uky.edu
