The Tisch Cancer Institute

Clinical Research Support Unit

The Clinical Research Support Unit (CRSU)—operated by the Clinical Protocol and Data Management team—assists The Tisch Cancer Institute investigators in the development , conduct, and reporting of innovative clinical research in an efficient, regulatory-compliant, and scientifically sound manner. The CRSU comprises specialized units that support disease-specific research teams. It provides study coordination, data management, regulatory management, pre-award budgeting, training and education, all in a manner that complements the Protocol Review and Monitoring System.

All cancer clinical trials are monitored according to guidelines in the TCI Data and Safety Monitoring Plan (DSMP). A formal Data and Safety Monitoring Committee (DSMC) ensures that TCI investigator-initiated clinical trials are compliant with the DSMP. The DSMC reviews, on an ongoing basis, data regarding safety and efficacy from active investigator-initiated clinical trials deemed high-risk to ensure the safety of study participants.

Clinical trials at TCI include significant percentages of patients representing minority populations and women, as well as pediatric and elderly patients.

Oversight of clinical research is intended to ensure that The Tisch Cancer Institute investigators conduct high-quality science in a responsible manner, with minimal risk to patients. 

Karyn Goodman, MD, MS
Associate Director, Clinical & Translational Research

Ajai Chari, MD
Associate Medical Director, CRSU

Paula Klein, MD
Associate Medical Director, CRSU

Vaibhav Patel, MD
Assistant Medical Director, CRSU

 

The CRSU is organized by divisions that provide distinct, well-integrated services under unified leadership reporting to the Executive Director of Clinical Research Administration. Skilled personnel are available to assist Investigators by providing administrative, regulatory, finance management, study coordination, quality assurance, educational support and data management and reporting.

Therica Miller
Executive Director of Clinical Research Administration

Jennifer Cocco
Director, Research Information Systems 

Christa Varnadoe
Nurse Manager

Yolanda Rockhead-Carter
Assistant Director, Clinical Trials Finance

Shakira Forde
Associate Director, Quality Assurance & Regulatory Compliance

Clinical research nurses and coordinators have regular assignments with investigators by disease-specific research teams to build expertise in particular areas of oncology.

Breast & Head and Neck
 
Early Phase Trials Unit (EPTU)
 
Malignant Hematology- Myelodysplastic Syndromes (MDS)
         
Malignant Hematology-Multiple Myeloma
 
Malignant Hematology- Myeloproliferative Diseases (MPD)
  
Immunotherapy/Vaccine
 
Radiation Oncology
 
Grace Lee
Thoracic
 
GU
 
Leukemia
 
Lymphoma & BMT
 

The Clinical Research Support Unit currently supports three prestigious research consortia:

MAGIC-Mount Sinai Acute GVHD International Consortium: Composed of 10 major stem cell transplant centers in the United States and Europe who are collaborating to use this new scoring system to test new treatments for acute GVHD.

Contact: Rachel Young

The Myeloproliferative Neoplasms Research Consortium (MPN-RC): Is an inter-active group of laboratory scientists, clinical scientists, and a biostatistics team, who work in coordination to develop and evaluate treatments that will improve the survival of patients with myeloproliferative neoplasms (MPN). The overall goal of the MPN-RC is to merge the skills and efforts of its scientifically diverse membership to generate the scientific foundation for novel therapeutic strategies which will be evaluated in rigorous, well- constructed independent investigator-initiated clinical trials. Currently, the MPN-RC has investigators in 11 institutions around the US and in Canada.

Contact: Lonette Sandy      

MyTRO- Myeloma Translational Research Organization: A unique clinical research organization connecting sites and myeloma patients with promising drugs through clinical trials. MyTRO offers an efficient solution from providing multiple research sites in the tri-state area.

Contact: Schantel Williams