Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Endocrinology
Family Medicine
Gastroenterology
Genetic Disease
Hematology
Infections and Infectious Diseases
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Oncology
Orthopedics/Orthopedic Surgery
Pediatrics/Neonatology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma (Emergency, Injury, Surgery)
Urology

Center Overview

The Clinical Research Organization at the University of Medicine and Dentistry of New Jersey (UMDNJ) assembles the expertise, resources, intellect and motivation of faculty and staff across three medical schools and a dental school, six clinical research centers, and the technical and scientific capabilities of a state-wide institution to conduct clinical research in nearly all therapeutic areas. Each school and campus provides their own set of comprehensive research activities and is supported by a core of shared administrative competencies in human subjects protections, financial management, legal management and technology transfer. The CRO provides a portal into the University to select services at specific sites, or concurrent services at multiple sites across the state; it matches internal capabilities with external constituents. A full description of our main biomedical research schools can be found at the following CenterWatch.com links:

• New Jersey Dental School, Newark
• New Jersey Medical School, Newark
• Robert Wood Johnson Medical School, New Brunswick
  • Cancer Institute of New Jersey, New Brunswick
• School of Osteopathic Medicine, Stratford

The UMDNJ CRO may be reached by contacting Ms. Debbie McCloskey, RN, BSN at CRO@umdnj.edu

Robert Wood Johnson Medical School (RWJMS) is one of three medical schools at the University of Medicine and Dentistry of New Jersey (UMDNJ) and is located in New Brunswick, NJ, an epicenter of top health care providers and pharmaceutical research companies. The School has 22 basic science and clinical departments with nearly 2500 faculty on its three regional campuses. It also includes six major institutes and integrates diverse clinical programs conducted at hospital affiliates and ambulatory care sites throughout the state. Major institutes include:

• The Cancer Institute of New Jersey (CINJ), received designation as an National Cancer Institute Comprehensive Cancer Center in recognition of its strong core of basic, translational, and clinical research, clinical trials, cancer prevention and control research, and research training and continuing education. CINJ manages more than 80,000 patient visits each year. In addition, over 15,000 cancer patients are diagnosed and treated annually at one of CINJ's network hospitals across New Jersey.
• The Center for Advanced Biotechnology and Medicine (CABM) faculty conduct basic research in cell and developmental biology, molecular genetics, and structural biology.
• The Environmental and Occupational Health Sciences Institute (EOHSI) is dedicated to a broad understanding of health effects associated with environmental and occupational chemical exposures and to the development of public policies related to these exposures.
• The Child Heath Institute of New Jersey (CHINJ) is a comprehensive biomedical research and pediatric care center and serves as the cornerstone of the children’s academic campus of the medical school, and forges the scientific and clinical programs at the Institute with hospital based programs.

University of Medicine and Dentistry

UMDNJ, founded in 1970, has eight schools located throughout New Jersey. Our main campuses are Newark, Piscataway/New Brunswick, Stratford and Camden. Our campus collectively inhabits 185 acres, 64 buildings, 7.2 million square feet.

Our Schools include:

• New Jersey Medical School
• Robert Wood Johnson Medical School
• School of Osteopathic Medicine
• New Jersey Dental School
• Graduate School of Biomedical Sciences
• School of Health Related Professions, School of Nursing, School of Public Health.

UMDNJ Clinical Research Organization

• The University Clinical Research Organization (CRO) offers a gateway for current and future patients and sponsors into campus-wide clinical trial activities.
• The University CRO works with private sponsors to provide a single University-wide contact.
• The University CRO works with clinical trial units and research offices of each UMDNJ school to efficiently and effectively match trial and sponsor needs with University resources.

Our health care system includes:

• 2.3 million patient visits to UMDNJ healthcare facilities and faculty practice offices last year
• Owns and operates UMDNJ-University Hospital (UH) in Newark with 22,192 admissions
• 221,371 outpatient visits last year
• Owns and operates University Behavioral HealthCare (UBHC), a state-wide behavioral health care provider.
• Four Principal Teaching Hospitals
• Three University Hospitals
• Affiliations with more than 80 New Jersey hospitals and/or health systems
• More than 15 statewide centers of excellence

Clinical Research Experience

UMDNJ-RWJMS participates in all phases of research, including Phase I, II, III, IV trials as well as outcome and epidemiological research. RWJMS departments include:

Facility Description

Robert Wood Johnson Medical School integrates diverse clinical programs conducted at hospital affiliates and ambulatory care sites throughout the state. The school has three campuses in New Jersey: Piscataway, which houses much of the didactic education; New Brunswick, which focuses on clinical education; and Camden, which focuses on clinical education. RWJMS has two principal teaching hospitals

• Robert Wood Johnson University Hospital, New Brunswick and
• Cooper Hospital/University Medical Center, Camden.

Core facilities provide the research community with specialized instrumentation, services and methodology. The core facilities area located throughout the campuses, allowing for accessibility by all faculty, staff and students.

The RWJMS Adult Clinical Research Center (CRC) brings together basic, clinical and translational researchers to develop novel and productive research projects and facilitates interactions with industry sponsors and collaborators in the performance of clinical and translational research. The CRC provides access to highly trained and dedicated research staff with expertise in Phase I – IV clinical trials. The CRC also offers access to a highly trained, dedicated research staff with expertise in Phase I-IV clinical trials. CRC staff offer nursing, pharmacy, and clinical laboratory services for all clinical trial needs, including regulatory, administrative, educational and operational protocol support. In addition, the CRC facilitates interactions between industry sponsors and faculty collaborators in the performance of clinical and translational research.

The CRC mission is to

• support and stimulate clinical and translational research throughout Robert Wood Johnson Medical School,
• provide a conduit by which industry sponsors and other collaborators may access the abundant clinical expertise, extensive patient networks and impressive research talent available in UMDNJ-Robert Wood Johnson Medical School and its affiliates; and
• bring new therapies, tests and treatments more rapidly to the community.

Easily accessible, the CRC is located at the heart of the Robert Wood Johnson University Health System for the easy placement of clinical trials. The 15,817 GSF include:

• Spacious 22 bed inpatient facility
• Four private rooms equipped for cardiac monitoring
• Two private rooms equipped for isolated electronic monitoring with one-way glass
• Four outpatient examination and treatment rooms
• Full research core facilities
• Research Pharmacy

The pediatric CRC in the CHINJ, conceived seven years ago, is self-contained, including four beds, a children’s playroom, laboratory, a waiting area and exam rooms. Trials come through the private and public sponsors. New therapies in all stages of development are tested on young children and teens for conditions as varied as cystic fibrosis, kidney disease, systemic infection, diabetes, migraine, digestive problems, HIV, and blood irregularities caused by cancer chemotherapy.

The Clinical Research and Occupational Medicine Division of EOHSI examines the consequences of environmental and occupational exposures using experimental and observational methods on human subject in a controlled exposure facility. Its efforts are funded mainly by NIOSH, NIEHS, DOE, USEPA, and other sources. This EOHSI division includes over 30 full- and part-time staff, augmented by associates from the Robert Wood Johnson Medical School, Rutgers-Cook College, and the regional occupational medicine community.

CINJ is one of the nation’s 40 National Cancer Institute-designated Comprehensive Cancer Centers and the only one in New Jersey. The Institute delivers advanced comprehensive care to adults and children, and conducts cutting-edge cancer research. CINJ’s research programs and core facilities enhance and support the activities of over 250 faculty members, whose activities typically enroll more than 1,000 patients in clinical trials annually. CINJ not only conducts trials at the main facility, but helps bring clinical trials to communities throughout the entire State of New Jersey. Special CINJ faculty collaborate with local community physicians to bring the strengths and expertise of CINJ providers closer to home. Participants may be able to participate near their own community, eliminating the need to travel to the main facility in New Brunswick, and receive health care from a team they already know. Dispersing clinical trials also supports research goals by increasing the access to trial enrollment.

The Investigational Drug Service (IDS) of the Robert Wood Johnson Medical School is a cooperative service with the Department of Pharmacy of the Robert Wood Johnson University Hospital.

Laboratory Services which serve the RWJMS community include:

• Pharmacokinetic and pharmaco-dynamic study capabilities
• Protocol specific specimen processing, storage and shipment
• Development of necessary study-related documentation such as specimen processing manuals, logs, etc
• Cell isolation
• Tissue culture
• ELISA
• DNA sequencing
• Immunohistochemistry
• Serum and Tissue banking capabilities
• Flow cytometry
• Western Blot

Core Facilities for the RWJMS community include:

• Analytical Ultracentrifugation Facility
• Center for Biostatistics
• CINJ–Core Expression Array Facility
• CINJ - Research Pharmacy
• Circular Dichroism Facility
• DNA Synthesis and Sequencing Laboratory
• Electron Microscopy Lab
• EOHSI - CINJ Flow Cytometry Core Facility
• EOHSI / NJDEP Analytical Center
• Laser Scanning Confocal Microscope Facility
• MALDI Mass Spectrometry Facility
• Phosphorimaging and Microarray Facility
• RWJMS / CABM Biomolecular NMR Facility
• RWJMS Confocal and Electronic Imaging Center
• RWJMS Surgery Outreach
• Shared Equipment Services
• Tissue Analytical Services

Investigator Experience

The school has significant experience in nearly all levels of clinical research in the full breadth of therapeutic areas. As investigators and scientists, our faculty are internationally known as prominent leaders in their respective fields. As physicians, they are motivated to improve not only the general health status of our state, country and world at large, but are also dedicated to applying the best medical care to each patient.

Staff Expertise

The research staff has extensive experience in initiating and conducting clinical research projects of all phases and magnitudes. Their expertise includes, but is not limited to, study coordination, data and project management, human rights protection, patient safety and Good Clinical Practices, regulatory compliance, contracts and budgets, and coordinator support for new investigators. Our staff is well versed in acting as a central contact for sponsors and CROs.

Patient Demographics

We serve an economically and ethnically diverse patient population from the entire state of New Jersey and parts of Pennsylvania.

Other Information

Open Clinical trials actively recruiting patients at RWJMS registered with the federal government at ClinicalTrials.gov are listed below. Please choose the appropriate conditions to see the actual titles and descriptions of clinical trials being conducted here at RWJMS. This listing includes Clinical Trials at the Cancer Institute of New Jersey.

• Bacterial & Fungal Diseases
• Behaviors & Mental Disorders
• Blood & Lymph Conditions
• Cancers & other Neoplasms
• Digestive System Diseases
• Diseases & Abnormalities at or before Birth
• Ear, Nose, & Throat Diseases
• Eye Diseases
• Gland & Hormone Related Diseases
• Heart & Blood Diseases
• Immune System Diseases
• Injuries, Poisonings & Occupational Conditions
• Mouth & Tooth Diseases
• Muscle, Bone, & Cartilage Diseases
• Nervous System Diseases
• Nutritional & Metabolic Diseases
• Respiratory Tract (Lung & Bronchial) Diseases
• Skin & Connective Tissue Diseases
• Symptoms & General Pathology
• Urinary Tract & Sexual Organs & Pregnancy
• Viral Diseases

Additional Contact Information

Ms. Debbi McCloskey, RN, BSN
UMDNJ-CRO
New Brunswick, NJ
CRO@umdnj.edu