Administrative and Clinical Research Support Core

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The broad objective of the Administrative and Clinical Research Support Core is to provide essential administrative and clinical research support for the Projects and other Cores fundamental to the success of this Program Project Grant. The administrative components of the Core focus on accounting, budgeting, regulatory reporting and, most importantly, fostering team science by providing multiple opportunities for communication between project and core investigators, external collaborators and the External Advisory Board members. Core A will also facilitate clinical trial activation and execution and protocol specific training for the faculty and research staff as well as nurse coordinators and advance practice providers working in the inpatient and outpatient clinical units to maximize trial safety and integrity. To accomplish our objective, there are 4 specific aims: Aim 1: Scientific Oversight is focused on facilitating communication between investigators in projects and cores, arranging annual retreats for the Program’s team and annual meetings with an External Advisory Board, composed of 4 renowned experts in the field of immune effector cellular therapy, and other key leaders in the field on an ad hoc basis. The Programs’ leaders will continually seek areas of collaboration within and outside the Program with investigators with expertise. Aim 2: Administrative and Financial Support is focused on general accounting and fiscal support associated with the grant overall and individual projects and cores, and assistance in the completion of progress reports. Aim 3: Clinical Oversight and Services is focused on providing the support staff necessary for the preparation of clinical protocols and applications to regulatory bodies, maintenance of clinical protocols, regulatory assistance for IND submissions and reporting, and management of audits by internal and external agencies, and trial monitoring. Core A is also be responsible for development of data management plans, case report forms and patient study treatment calendars, as well as the collection of data from each of the clinical units, meeting the data management agreements with our clinical partner, MHealth-Fairview. Aim 4: Faculty and Staff Education is focused on enhancing staff and faculty education in the rapidly evolving field of cell, gene and immunotherapy. This will be accomplished through standing seminars and grand rounds and other clinical program meetings. Here, we bring in outside leaders in the field to present seminars and meet with senior and junior faculty and trainees, often leading to new collaborations, magnifying our successes in translational medicine. Aim 5: Enrollment Optimization and Enhanced Subject Education is novel unique approach for predicting and enhancing patient accrual and subject understanding in support of the proposed clinical trials. These tools developed by investigators at the University of Minnesota identify barriers to accrual and subject understanding, permitting interventions prior to trial initiation. The long-term objective is the rapid and safe translation of allogeneic immune effector cell therapies in the treatment of cancer that more effectively target and kill tumor cells with fewer adverse effects.