Services and Equipment

CLINICAL SERVICES

An experienced clinical research staff consisting of physicians, nurse practitioners, registered nurses and research technologists work closely throughout the study with investigators to optimize and facilitate the research protocol. The GCRC encourages a collaborative environment between the clinical staff and investigators. Each GCRC approved protocol is assigned a physician who will be involved in the development and execution of the research protocol and continues to serve as the primary contact on medical issues throughout the study. Investigators and physicians are encouraged to communicate throughout the study when questions or concerns arise.

Clinical staff skills and support services for protocols include:

Facilities and Equipment

The GCRC Clinical Department is located on the second floor of the Elmore Clinical Research Wing
Equipment and Facilities to be shared by investigators include:

Department Staff

Physicians
Philip Bosha , M.D.
Teresa Dolan, M.D.
Roberta Millard, M.D.
Clinical Nurse Coordinator
Paula Mulhall
Nurse Practitioner
Elizabeth Abraham, CRNP
Clinical Research Nurses
Laurie Aquillino, RN
Cindy Flanagan, RN, BSN
Filomena Martin, RN
Beth McKee, RN, BSN
Rebecca Reinhard, RN
Denise Sheffield, RN
Research Technologists:
Rebecca Falsone, BS, MT (ASCP)
Sharon Fong, BS, MT (ASCP)

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NUTRITIONAL SERVICES

The nutritional staff includes registered dietitians, a certified dietary manager, and student kitchen employees who work together with investigators to plan, prepare, and deliver weighed metabolic or constant diets for research studies.

Nutrition staff skills and support services for protocols include:

The GCRC includes a fully equipped research kitchen

Facilities and Equipment

The GCRC Nutrition Department is located on the ground floor of the Elmore Clinical Research Wing. Facilities and equipment include:

Department Staff

Nutrition Research Manager: Mary Lou Kiel, Ph.D., RD

Research Nutritionist: Amy Ciccarella, RD, LDN

Metabolic Kitchen Manager: Sami Heim, BS, CDM

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ADMINISTRATION

Associate Medical Director

Dr. Jan Ulbrecht, Associate Medical Director of the GCRC at Penn State's University Park Campus has administrative oversight of the Center to include quality of inpatient and outpatient medical care, nursing, core laboratory, and research bionutrition staffs.

Advisory Committee

The UP GCRC Advisory Committee (GAC) is appointed by the Dean of the College of Health and Human Development on a rotating basis and is responsible to the Dean. The GAC, along with the Associate Director, supervises and reviews the operations of the GCRC, its Core Laboratoraies and Informatics Core; sets general policies; and delineates common needs of the GCRC investigators. The GAC also reviews and prioritizes projects based on scientific merit and GCRC utilization. Studies must have GAC approval prior to initiation.

Administrative Manager

Sue Eberly, Administrative Manager, is responsible for the day-to-day management of GCRC administration, fiscal matters and records of GCRC activities at the University Park GCRC. The administrative manager is available to meet with investigators to discuss the use and resources of the GCRC and to assist with the application process.

Support Staff

Sheryl Shaffer, GCRC Staff Assistant, supports various functions within the GCRC. She acts as receptionist for GCRC research subjects, provides support for various nursing functions, and provides staff support to the Research Subject Advocate.

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INFORMATICS

The GCRC Informatics Core provides investigators the resources necessary to accurately collect, appropriately monitor, securely store, continually backup, and in affiliation with the biostatistician, analyze data for appropriate reporting. The Informatics Core provides file, print, and web server services, Internet connectivity, and technical support to investigators and their staff.

Department Staff

Informatics Manager: Don Fink

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BIOSTATISTICS

The GCRC biostatisticians are available to help investigators with study design, implementation, sample size and power estimations, data analysis and related issues. The biostatistician reviews all protocols and is a voting member of the GCRC Advisory Committee. Investigators are encouraged to meet with the biostatistician before submitting a protocol to the Advisory Committee.

Department Staff

GCRC Biostatistician: Mosuk Chow, Ph.D.

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RESEARCH SUBJECT ADVOCATE

The Research Subject Advocate (RSA) is responsible for ensuring that all steps are taken to maximize patient safety as detailed in the protocols approved by the IRB and the GCRC Advisory Committee (GAC). The RSA is to ensure that the GAC-approved data and safety monitoring plans are fully implemented, that research carried out on the GCRC is in compliance with the IRB-approved protocol, and that serious adverse events are reported in a timely fashion to the IRB and appropriate Federal agencies. The RSA is available to assist investigators in formulating data and safety monitoring plans and to serve as an unbiased observer during the consent process when requested by either the research volunteer or investigator. The RSA reviews all protocols concentrating on the risk/benefit and consent items and his recommendation is passed on to the GAC at the time of the meeting.

Department Staff

Research Subject Advocate: Robert Mooney, Jr., D.O.

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IMMUNOMODULATION CORE LABORATORY

The GCRC Immunomodulation Core Laboratory has the capability of assaying human blood (plasma, serum, whole blood spots) and tissue specimens. Core Lab personnel are also available to train and supervise research team members in the principles and procedures necessary to develop their own immunoassays from "scratch" for any antigen for which antibodies are available.

The assays currently available for GCRC users are as follows:

CRP, GP130, IFN-y, IGF-1, IGFBP-3, IL-1a, IL-1B, IL-1ra, IL-1 sRII, IL-2, IL-4, IL-6, IL-6 sR, IL-7, IL-8, insulin, leptin, MIF, TNFa, TNF sRI, MCP-1, TGF-B1, TGF-B2, VEGF, Cortisol

The Core Lab will also be happy to work with researchers to develop new assays depending on projected usage.

Facilities and Equipment

The Core Laboratory is located in 118 and 120 Elmore Wing/Noll Lab. Laboratory equipment includes:

Department Staff

Core Lab Director: Andrea Mastro, Ph.D.

Senior Research Assistant: Richard Ball

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OFF-SITE SERVICES

Requests for research activities by GCRC grant-supported personnel performed at locations other than the GCRC may be considered. An assessment of the facility in which the off-site visit is to be conducted must not compromise research subject safety or data confidentiality, and medical coverage appropriate for the risk level of the proposed activity must be available. The GCRC Advisory Committee must approve such off-site services in accordance with NCRR Guidelines for General Clinical Research Centers.

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ANCILLARIES

The GCRC has limited funds available for routine and specialized laboratory tests performed at the Noll Laboratory, in the Immunomodulation Core Laboratory and to be sent to appropriate outside laboratories. The Core lab staff can help facilitate the selection of laboratory tests for use in study protocols. Other ancillary procedures, such as x-rays and CT scans can also be arranged.

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BONE DENSITOMETER (DXA)

The GCRC offers space and personnel for DEXA testing

The GCRC provides space and personnel to perform bone density testing, however, the machine is owned and maintained by the Center for Locomotion Studies (CELOS). The following agreement exists with the GCRC:

For all GCRC protocols, the investigator will be charged an equipment fee of $28.00 per scan, payable directly to the Center for Locomotion Studies.

For all non-GCRC protocols, the investigator will be charged an equipment fee of $28.00 and an operator fee of $28.20 per scan.

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ULTRASOUND MACHINE

We are pleased to announce the addition of an Acuson Aspen Ultrasound machine to our list of resources.  This is a state-of-the-art, fully functional clinical ultrasound machine  which includes cardiac and vascular probes.  The machine is owned by Drs. Sheila West and Penny Kris-Etherton, with additional funding for maintenance being provided by the GCRC and the Department of Kinesiology.  The GCRC provides space to house the equipment and to perform the scans, and will facilitate training of individual users in the safe operation of the equipment.  Training specific to the scientific integrity of the data will be the responsibility of the investigator. If you or members of your research team anticiptate using this equiment, please contact Sue Eberly to make arrangements for training prior to scheduling research subjects.

The machine is available for use by investigators with GCRC approved protocols and must be scheduled with the nursing stff in the GCRC.  Schedule requests will be treated according to existing poilcies (Hours of Service and Reservations; Resource Allocation), except that studies with Drs. West and Kris-Etherton as investigators will have priority access to the machine.

While the machine is covered by a maintenance contract, any damage to the macihne through misuse that may not be covered will be the responsibility of the user.  Individuals wishing to use the equipment must receive instruction prior to use. 

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SPACE

Space in the GCRC is available for use by investigators with approved GCRC protocols.  Space required outside of a scheduled nusing or nutrition visit should be discussed with the GCRC Administrative Manager and scheduling of the space will follow guidelines established in the Hours of Service and Reservations policy.  The calendars to determine space availability in the GCRC can be viewed at the following links:

To schedule the space please contact Sheryl Shaffer at sks21@psu.edu.

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