From left: Betty Chen, FNP; Rachelle Mallare, RN; Margaret Garrett, FNP; Christian Malatesta, FNP; Berenissis Valenzuela, MA; Karmiely Morillo, Patient Coordinator
The Clinical Research Unit (CRU) is a valued resource hub for researchers at Mount Sinai—providing everything from exam rooms, to research space and specimen storage, to compassionate nursing support, and help with administrative and procedural tasks.
Manisha Balwani, MD, MS, Chief of the Division of Genetics and Genomics, is appreciative of the skill and compassion of the team. “The CRU team have truly been excellent partners in getting rare disease treatments to patients. They have the skills to navigate administering complex therapies while creating a safe environment for patients who are vulnerable and anxious.”
The center was established in 1963 as part of a nationwide effort by the National Institutes of Health to provide dedicated space and resources for conducting medical research across medical disciplines within academic medical centers. Located in the Annenberg Building at The Mount Sinai Hospital, the CRU is a comprehensive resource hub for investigators and the Mount Sinai community who wish to undertake clinical research. Currently there are 122 active ongoing studies across multiple disciplines.
Christian Malatesta, FNP, on staff at the CRU, and at Mount Sinai for 30 years, calls the unit a “hidden gem” that is especially valuable for investigators who do not have the time or resources to implement the clinical procedures required for clinical trials. Along with Betty Chen, FNP, and Unit Nursing Director, Margaret Garrett, FNP, the team of nurse practitioners, one registered nurse, and one medical technician, are able to assist with study-related medical evaluations of research participants, including:
- Performing physical examinations
- Administering study medications
- Adverse event monitoring including telemetry monitoring
- Obtaining electrocardiograms
The team also assists with reviewing signed consent forms and the required study-related schedules of events to ensure that all elements are in place to safely and effectively proceed with clinical procedures.
Investigators across the system value their partnership with the CRU.
Alexander Kolevson, MD, a principal investigator on studies in autism spectrum disorder as part of the Seaver Autism Center for Research and Treatment, says, “We believe our work has made major contributions to the field of autism and neurodevelopmental disorders and I’m not exaggerating when I say that we could not have done it without the outstanding CRU team. They are highly skilled and consistently flexible and accommodating. Importantly, our most severely disabled and behaviorally challenging patients are treated effectively with kindness and empathy.”
Stephen Krieger, MD, FAAN, a neurologist at The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, also praises the CRU. “We are currently the only recruiting site in New York City for a trial of a new infused monoclonal antibody for progressive multiple sclerosis (frexalimab), and my team has worked hand-in-hand with the CRU from our initial site assessment and activation through to the enrollment and infusion of our patients. I am very grateful to the CRU team for their professionalism and the warm and compassionate way they have worked with our patients, many of whom have significant disability from their neurological disease.”