Clinical Trials Unit
The Clinical Trials Unit (CTU) operates under the auspices of the Center for Cellular Immunotherapies (CCI) Medical Affairs Department under the direction of Dr. David Porter. As head of Medical Affairs, Dr. Porter engages with CCI as a thought leader in developing innovative cellular therapies, collaborates in trial design, provides medical expertise, weighs in on scientific merit of the trials, and identifies unmet medical needs and opportunities for pioneering new technologies. The CTU is under the direct management of its Administrative Director Lester Lledo, MSN, CRNP, who is responsible for management of programmatic operations pertaining to staffing, process workflow, standard operating procedures, compliance with federal regulations and institutional policies. Directly reporting to Lester Lledo are his team of managers who are responsible for oversight of the daily activities of the research staff and their assigned projects. The CTU is comprised of well educated and trained research personnel who carry-out a variety of responsibilities and functions directly related to the execution of the study protocols. Collectively this division of CCI seeks to shift the paradigm for the standards of clinical research in oncology.
- Focus on safety and rights of human subjects participating in clinical trials.
- Facilitate continuity of medical care during study participation.
- Conduct of Exploratory-Pilot through Phase II first in human clinical trials.
- Support research and development of novel therapies targeting cancer.
- Ensure that clinical trials are conducted in compliance with all applicable federal regulations, ICH/GCP guidelines and institutional policies.
- Ensure accurate, complete and timely data collection and reconciliation of data discrepancies.
- Lester Lledo, MSN, CRNP- Director
- Joan Gilmore, BS, CCRP – Associate Director
- Karen Dengel, RN, BSN – Research Nurse Manager
- Jane Anderson, MS, CCRC – Sr. Regulatory Specialist
- Aliza Schmidt, MS, MBE- Research Project Manager
- Research Nurses and Clinical Research Coordinators – personnel who support conduct of and coordinate study subject participation in our clinical trials
- Regulatory Coordinators – personnel who perform submission of the protocol and all related study documents to our internal/institutional regulatory committees (i.e., IRB) for review and approval and coordinate completion of all regulatory documents and correspondences that support the protocol review and approval
- Data Coordinators – personnel who perform real-time data entry of research data from study and coordinate data discrepancy reconciliation to ensure high quality data
- Research Billing/Compliance Manager – personnel who performs quality control of research billing charges and reconciliation to ensure accuracy of research charges and compliance of research billing with institutional policies and standards.