Stern Center for Cancer Clinical Trials and Research Home Research Clinical Research Stern Center for Cancer Clinical Trials and Research Centralized Office for Cancer Clinical Research Operations at UCI The Sue and Ralph Stern Center for Cancer Clinical Trials and Research (Stern Center) is the centralized office for cancer clinical research operations at UCI, providing high-quality and efficient support for the development, activation, and completion of scientifically impactful cancer clinical trials. The Stern Center manages the largest portfolio of clinical trials at UCI, with a reputation as a visionary and best-practice leader in clinical research operations across the institution. Cancer clinical trials supported by the Stern Center are active at four geographically distinct sites, the primary CFCCC location on the UCI Health Medical Center campus (Orange), the UCI Health Gottschalk Medical Plaza (Irvine) and two satellite Cancer Centers (Costa Mesa, Yorba Linda). Stern Center services support the entire lifecycle of all cancer-related clinical trials. This includes support for development and implementation of clinical trials, quality control of clinical research operations, training, and education services. Stern Center Leadership Susan O'Brien, MD Associate Director for Clinical Science Medical Director, Sue & Ralph Stern Center for Clinical Trials & Research Ashley Tydon Administrative Director for Clinical Research Operations Johanna Han, MSc, CCRP Assistant Director, Clinical Trials Unit Stern Center Organizational Structure The Stern Center is composed of five distinct but collaborative units. These are the Quality Assurance, Protocol Review and Monitoring, Regulatory Affairs, Clinical Trials and Clinical Research Finance Units. Together, they provide administrative support, comprehensive regulatory management, clinical research coordination, data management, Data Safety Monitoring, and business support to all CFCCC members. Quality Assurance Unit The Quality Assurance Unit (QAU) monitors and audits all Investigator Initiated Trials. The QAU maintains a culture of excellence, safety, and compliance in order to establish audit-ready operations at all times. Audits are conducting according to the Stern Center’s Quality Assurance Monitoring and Auditing Plan. The QAU leads and coordinates external audits for all trials and helps scale and implement clinical research training programs based, in part, on recorded audit findings. Protocol Review and Monitoring Unit The Protocol Review and Monitoring Unit (PRMU) provides administrative management and support to the CFCCC’s comprehensive system of research oversight. Three distinct committees work collaboratively to provide robust oversight of all aspects of clinical research conducted at the CFCCC. The Protocol Review and Monitoring Committee (PRMC) together with the seven Disease-Oriented Teams comprise the CFCCC’s two-stage Protocol Review and Monitoring System. The Data and Safety Monitoring Board (DSMB) is responsible for data and safety monitoring and protocol compliance oversight for interventional institutional trials. Regulatory Affairs Unit The Regulatory Affairs Unit (RAU) provides central management and oversight coordinating the regulatory affairs for cancer clinical trials. The regulatory affairs coordinators prepare submissions to all regulatory committees, including the Institutional Review Board and other required regulatory committees. The Senior Regulatory Affairs Coordinator manages study-start up activities for high priority trials and for the multi-site investigator-initiated research portfolio. The Regulatory Program Manager leads the unit, supervises the day-to-day management of the RAU, and works collaboratively with the Clinical Research Business Manager to ensure protocols are compliantly and expeditiously shepherded through the study start-up process. Clinical Trials Unit The Clinical Trials Unit (CTU) is led by Assistant Director Johanna Han, MSc, CCRP. The unit oversees clinical research coordinators (CRCs), clinical research managers (CRMs), data coordinators, biospecimen coordinators, and long-term follow up coordinators. The CTU’s disease-specific management teams support one or more Disease-Oriented Teams. CRCs attend tumor boards, screen clinic schedules for potential patients and are present in multidisciplinary clinics to provide a visible and vocal reminder for physicians and patients to consider clinical trials, when appropriate. CRCs work directly with faculty investigators. They are an integral member of the patient’s care team and help to identify potential patients, facilitate the consent process, and coordinate all aspects of protocol-directed care. They ensure patients receive safe, compliant, and exceptional care. Each management team is organized around one or more diseases and is led by an experienced CRM who actively manages the portfolio for the Disease-Oriented Team and Principal Investigators. The CRM helps to identify and fill critical gaps in the clinical trial portfolio and provides supervision of the day-to-day operations. CRMs lead the early study start-up process. This may include protocol development assistance for IITs and site-selection/feasibility support for all studies. CTU Management Teams Team A: Neurologic Oncology Team B: Hematologic Malignancies Team C: Lung Team D: Gastrointestinal, Skin, Head & Neck Team E: Gynecologic Oncology, Breast Team F: Genitourinary Clinical Research Finance Unit The Clinical Research Finance Unit oversees all pre and post-award finance activities for cancer-related clinical trials. The Clinical Research Business Manager oversees the development and finalization of all Medicare coverage analysis, budgets and contracts for cancer-related clinical trials. Clinical Research Finance Analysts manage all post-award finances, including management of accounts receivable, income reconciliation and distribution of funds.