Clinical Research Center
The CTSI operates five CRCs – four spanning the three major hospitals of the NYULH network in Manhattan, Brooklyn, and Long Island, with the fifth and largest CRC located in NYC H+H/Bellevue, the oldest and one of the largest public safety net hospitals in the US.
These facilities provide CTR resources reflecting collaboration of numerous CTSI investigational services operating under a single IRB. Each CRC includes adult and pediatric exam rooms, infusion suites, procedure and recovery rooms, investigational pharmacies, specimen processing labs, and Epic computer systems. The CRC workforce comprises certified clinical research nurses/NPs to provide oversight of studies and training in good clinical practice, coordinators to prepare regulatory documents and recruit research participants, and financial experts to build budgets and ensure compliance. The CRCs provide the research workforce with skills to overcome CTS barriers, such as working with underserved populations, at both the patient and staff levels.
Collectively, the CRCs conduct over 3,500 research visits annually across nearly 500 clinical trials (31% NIH, 51% industry, 11% foundation, 7% department). Since 2021, we have enrolled 4,648 participants (20% geriatric, 5% pediatric) across 369 unique zip codes (38% of which are in health professional shortage areas (HPSAs)). Work from the CRC have resulted in 125 publications and 28 NIH grants.
In addition to conducting clinical trials, the CRCs also provide education, training, and mentorship to students and trainees at various experience and educational levels to streamline and encourage entry into the CTR workforce. The CRCs have trained 127 students in clinical and translational research (60 high school, 30 undergraduates, 29 graduate, 8 doctoral, 2 science teachers).
Manhattan Clinical Research Centers
The NYU CTSI Manhattan Clinical Research Center (CRC) at Bellevue Hospital has been dedicated to serving the public since its establishment in 1960. Through our ongoing partnership with NYC Health and Hospitals (NYC H+H), our CRC has made a significant impact by reaching a diverse patient population and conducting high-quality clinical research that benefits our community and the underserved population. Our CRC research team plays a crucial role as institutional and network liaisons, ensuring access to resources such as our cutting-edge clinical research infrastructure, expert personnel (research nurses and coordinators), best practices, safety standards, services, and cost-effective utilization.
The CRC actively supports the use of innovative treatments and psychedelic research, including cannabidiol in patients with Dravet’s syndrome, Psilocybin for alcohol disorder and depression, and MDMA for PTSD.
In line with our commitment to expansion, the Manhattan CRC is broadening its clinical research services by establishing a new site in the Medical Science Building (MSB), offering additional infrastructure and support for investigators within the NYU superblock.
Throughout the COVID-19 pandemic, the CRC staff worked collaboratively with the Vaccine Center to facilitate various vaccine trials in response to public health emergencies. The proximity of the new CRC to the Vaccine Center ensures seamless collaboration and support for all vaccine studies.
Long Island Clinical Research Centers
The NYU CTSI Long Island CRC was established in 2001 and is currently located in the Research and Academic Center; 101 Mineola Boulevard. The new Long Island CRC, located in the NYU Langone Ambulatory Care Garden City at 1111 Franklin Avenue, was created in order to expand NYU Long Island Hospital’s clinical trial presence by providing comprehensive clinical research support to investigators based at NYU Langone Ambulatory Care Garden City. This CRC is the first of its kind to be embedded in an FGP Ambulatory Care Facility.
Our Long Island CRCs will support studies in pediatric and adult endocrinology, pulmonary medicine, neurology, pediatric genetics, rheumatology, allergy, surgery, and pediatric and adult infectious disease. During the pandemic in 2020, the CRC played an important role by allowing for rapid rollout of COVID-19 treatment and vaccine studies through collaboration with specialty physicians across the NYU Campuses and the Vaccine Center. At the height of the pandemic, the CRC provided implementation and regulatory support in order for physicians to begin several landmark, in-patient treatment studies.
The Vaccine Center, led by Dr. Mark Mulligan, was established as one of ten Vaccine Treatment and Evaluation Units (VTEU) by the National Institute of Allergy and Infectious Disease (NIAID). The Long Island CRC is home to the LI satellite of the NYU Vaccine Center/VTEU. In the four years since its inception, the CRC has supported and continues to support 8 Vaccine Center trials, including an NIH-sponsored phase 1 intranasal COVID-19 booster vaccine and a Pfizer-sponsored phase 3 pediatric Lyme vaccine study. The nearly 300 patient volunteers seen by the Long Island Vaccine Center satellite come from as far east as the Hamptons to as far north as Boston.
The CTSI CRC located in the Research and Academic Center will continue to support trials that require close proximity to the hospital, in-patient research, phase 1 studies and the vaccine center.
Brooklyn Clinical Research Centers
The Brooklyn CRC is located on the second floor of the Augustana building, located near other research facilities like the Center for Biospecimen Research & Development (CBRD). It was established in 2022 to develop infrastructure and personnel required to grow clinical research in Brooklyn, while simultaneously expanding access to cutting-edge clinical trials to underserved and underrepresented populations. Integral to this mission was the development of a community–clinic linkage model of health care, addressing community and clinical needs through the lens of a social determinants of health (SDoH) framework.
Of the 509 participants seen at the Brooklyn CRC within the first 2 years, 60% identified as non-White; 20% as Hispanic or Latine and 28% spoke a language other than English, including Arabic, Bangla, Cantonese, English, Fuzhounese, Mandarin, Polish, Spanish, Urdu, Vietnamese, Italian, and Russian. Our participants live in 110 zip codes, 78% of which are within the Brooklyn borough and 66% within 5 miles of the CRC. 76% of these zip codes are designated as Health Professional Shortage Areas (HPSAs). 54% of our participants live within 10 miles of our CRC (24% of our participants live within 5 miles or less, 30% live within 5-10 miles), 12% live within 10-15 miles, 13% live within 15-20 miles, and 21% live greater than 20 miles away.
Outpatient Facility at Tisch Hospital
A separate satellite office at NYU Langone’s Tisch Hospital, suite 5B/C, supports outpatient visits for clinical research participants from 8 am–5 pm, Monday through Friday. Call the Clinical Research Center to schedule accommodations for off-hour services.
The outpatient facility is equipped with two exam rooms, an office, a reception area, a blood-drawing chair, a specimen preparation area with access to a centrifuge and −20-degree Celsius freezer, and a waiting area.
The satellite facility is only for use with study participants who are not acutely ill. Procedures permitted include physical exams, questionnaire administration, blood drawing, specimen processing, EKG, and minor diagnostics. Oral, injectable, and inhaled research medications may only be given in the presence of a physician or research nurse.
Before beginning your study, please meet with our Clinical Research Center program coordinator for orientation to learn how to submit participant encounter forms, review available equipment, and learn emergency procedures. You must have approval from the Clinical and Translational Science Institute Resource Allocation Program to use the outpatient facilities at Tisch Hospital.
Nursing and Clinical Research Coordinator Services
The Clinical Research Center is staffed by nurses and clinical research coordinators who provide high-quality, safe, and courteous care to research participants.
Our research nurses are skilled in monitoring and critically assessing study participants and are trained in the education of diverse populations so that they may achieve successful study outcomes.
All nursing staff are certified to provide basic cardiac life support and advanced cardiovascular life support, have experience providing support for phase 1 pharmacokinetic studies, and are certified in shipping and handling study specimens. They also mentor research coordinators and early career investigators to ensure that research protocols are implemented correctly.
Our clinical research coordinators are trained to prepare and submit regulatory documents, including institutional review board applications and consent forms; conduct participant screening and recruitment; acquire consent for study participation; administer questionnaires; complete case report forms; perform EKGs, take vital signs and anthropometric measurements, and draw blood; and are certified to ship and handle specimens.
If a research project has funding, investigators are charged for nursing and research coordinator services as well as for facility usage, equipment, exam rooms, and other supplies. For projects without sufficient funding, investigators can apply for a research voucher through our Resource Allocation Program to support these services.
Contact the Clinical Research Center
For more information about the Clinical Research Center, please contact program director Gabrielle Gold-Von Simson, MD, at Gabrielle.Gold-VonSimson@NYULangone.org or 212-263-5759.
To learn more about nursing or clinical research coordinator services, contact nurse manager Rosario Medina, MA, RN, CCRC, at Rosario.Medina@NYULangone.org or 646-501-0637.
To book facilities or schedule services, contact administrative coordinator Mellisa Suarez at Mellisa.Suarez@NYULangone.org or research data associate Brian Zabala at Briansigfried.Zabala@NYULangone.org, or call 212-263-6411.
Trial Innovation Network (TIN)
The Trial Innovation Network (TIN) offers investigators the opportunity to request consultations and resources for multicenter clinical trials and studies. These are designed to help investigators, for example, develop proposals into protocols, enhance study operations, or improve recruitment and retention. Some consolations developed into clinical protocols may be implemented in the Network and within the CTSA Program. To request an initial consultation please see the NYU TIN Request Form.
Clinical Research Simulations
Online tools and data networks provide information and support for studies and researchers in search of research participants.