CLINICAL RESEARCH SERVICES CORE

The Clinical Research Services Core (CRSC) enhances the services for existing studies involving human research subjects. This program currently provides oversight and facilitation of clinical trials and fulfills the needs of the basic and translational research proposed in our COBRE Phase III application. The core provides eight trained research study coordinators who assist the target investigators with study design and subject recruitment, budget and database management. Coordinators also facilitate interactions with the Institutional Review Board (IRB) by working with the target investigators on protocol development and consent to ensure that they meet institutional and federal requirements.

The Directors of the Clinical Research Services Core oversee the Nemours Mentoring and Advisory Committee (M/AC), which is an institutional team that mirrors the mentoring activities of the CPR and extends their services to the collective group of potential researchers at Nemours. Robert Akins, PhD, Technical Director of the Core and Chair of the M/AC, and Julia Barthold, MD, Medical Director for the Core and M/AC member, meet on a monthly basis with investigators in support of their pursuit of funding opportunities. Dr. Barthold is also a member of the Nemours Clinical Research Review Committee which allows further support of cross-institutional research infrastructure that coordinates with the CPR.

Currently there are eight clinical research coordinators (CRC) at AIDHC: Alicia Olivant Fisher, MS; Kimberly Klipner, RN, BSN, MS, CRCC; Lynn Marrs, RN, BSN, CRRC; Carol Prospero BS, MT, CCRC; Terry L.E. Miller, RN, BSN; Stacey P. Koletty, BS, CCRC; Pialee Roy, BS, CRRC; Tara Ketter, BS, CRRC. Our CRCs support more than 49 non-oncology clinical trials as well as more than 60 trials ongoing with the Children’s Oncology Group and other collaborating oncology research centers. The CRC group meets on a weekly basis with Gregory Stets, RN, MHA and Drs. Barthold and/or Akins with the goal of maximizing the capabilities of the CRSC to support Nemours investigators. A recent goal of this group is to define specific levels of coordinator expertise that can be used to inform CRC assignments in support of investigators based on the complexity of individual studies. Additionally, this effort will facilitate support and training of CRCs at various levels of expertise. Finally, Drs. Barthold and Akins are the Nemours PI and the Lead of the Mentoring, Education and Career Development Core, respectively, of the recently funded, NIH-supported Delaware-CTR program, whose activities dovetail closely with the goals of the CPR.

The Alfred I. duPont Hospital for Children of The Nemours Foundation has undertaken a large expansion project that will include a new clinical research inpatient unit especially designed to accommodate clinical research study patients in a state-of-the-art facility that will open by the end of 2014. This new patient-friendly unit will provide the capability for inpatient and outpatient clinical research studies and physiological testing in a comfortable setting for patients and family alike. With the addition of more patient rooms, the opportunity for additional clinical studies increases, and with that, the need for more staff.