Clinical Trials Office (CTO)

The Clinical Trials Office (CTO) currently manages more than 90 clinical trials within the Department of Medicine at the Icahn School of Medicine at Mount Sinai. The CTO office also works closely with Institutional Committees, including the Program for the Protection of Human Subjects.

We maintain compliance with all institutional, state and federal regulations throughout the course of each study. This CTO administrative infrastructure allows investigators to obtain approval for studies in a timely manner and supports institutional compliance with regulatory requirements. Principal investigators and their research teams are thereby able to focus the majority of their attentions on the scientific content and patient care of research.

Specifically, the CTO provides comprehensive services to support clinical investigators with:

  • Document preparation and submission to internal Department of Medicine Protocol Review Committee.
  • Determine in collaboration with Investigators protocol feasibility.
  • Financial Management during the lifecycle of the study.
  • Collaboration with sponsors and/or contract research organizations to prepare all pre-award documentation, including regulatory submissions.
  • Centralized study processes through the 3 Core Teams: Regulatory Affairs, Financial Management, and Clinical Coordinator.
  • The CTO staff serves as a clinical, regulatory, and financial resource for physicians and their staffs.

The Clinical Trials Office consists of Regulatory Affairs, Financial Management, and Clinical Coordinators.

The Mount Sinai Health System (MSHS); Department of Medicine Protocol Review Committee (PRC) reviews all industry sponsored clinical studies conducted under the auspices of MSHS, regardless of whether the research involves use of the DOM Clinical Trials Office shared resources or not.  All new protocols are reviewed and must receive full PRC approval in addition to the Program for Protection of Human Subjects (PPHS) approval before they can be activated.  Ongoing studies will be monitored for protocol accrual.

The purpose and rationale for the establishment of a Protocol Review is to provide a process by which the quality and scientific value of clinical research studies are assessed and conducted at the Mount Sinai. 

PRC Policies and Procedures

 

The CTO office has conducted over 550 clinical trials since 2004.   The CTO staff have successfully implemented and coordinated many large, multi-centered clinical trials. The impressive investigator panel includes more than 30 physicians conducting trials in numerous therapeutic areas.  The site is well equipped to perform Phase 1 through Phase 4 studies, including first-in-human PK and PD protocols. 

Research Experience

The CTO has conducted Phase I-IV studies in the following areas: 

  • Gastroenterology
    • C. Difficile Infection
    • Crohn's Disease
    • Irritable Bowel Disease
    • Pouchitis
    • Ulcerative Colitis

  • Immunology
    • Cushing’s Disease
    • Hereditary Angioedema (HAE)
    • Primary Immunodeficiency (PID)

  • Infectious Diseases
    • Bacteremia
    • Human immunodeficiency virus (HIV)

  • Liver Disease
    • Autoimmune Hepatitis (AIH)
    • Drug Induced Liver Disease (DILD)
    • Hepatitis B Virus (HBV)
    • Hepatitis C Virus (HCV)
    • Nonalcoholic fatty liver disease (NAFLD)
    • Nonalcoholic Steatohepatitis (NASH)
    • Primary Biliary Cholangitis (PBC)
    • Primary Sclerosing Cholangitis (PSC)
  • Pulmonary Disease
    • Asthma
    • Chronic Obstructive Pulmonary Disorder (COPD)
    • Interstitial Lung Disease (ILD)
    • Interstitial Pulmonary Fibrosis (IPF)
    • Nontuberculous mycobacteria (NTM) 
    • Sarcoid

  • Nephrology
    • Chronic Kidney Disease
    • Focal Segmental Glomerulosclerosis
    • Lupus Nephritis
    • End Stage Renal Disease

  • Rheumatology
    • Amyloid Disease
    • Lupus Erythematosus
    • Rheumatoid Arthritis


Research Staff

  • 9 full-time Clinical Research Coordinators
  • 4 Fill Time Regulatory Compliance Coordinatory
  • Financial Analyst
  • IATA Certified Staff
  • Experience using various platforms for Electronic Data Capture, electronic patient reported outcome devices and apps ("ePROs"), Interactive Voice Response System (IVRS), Interactive Web Response System (IWRS)         
  • Current Investigators

Diagnostic/Clinic Equipment

  • Calibrated weigh scales (analog and digital) ECG machine
  • ECG machine
  • Centrifuges (Ambient & Refrigerated)
  • Freezer (-20 and -70 degree Celsius)
  • Lab drawing and processing equipment
  • Access to Dry Ice
  • Extended stay capability-infusion rooms

Investigational Drug Service

  • Limited access, secure area with temperature controlled environment
  • Refrigerators and freezers are temperature monitored and alarmed
  • Dedicated research staff who perform accountability according to sponsor specifications

Learn more

The Staff directory is below: 

Administration
Medical DirectorLinda Rogers, MD
E-mail: Linda.Rogers@mssm.edu
Tel: 212-241-5656

Administrative Director: Michele Cohen, MS, CCRC
E-mail: Michele.Cohen@mssm.edu
Tel: 212-241-7734

Recruitment Specialist: Catherine Sinfield, PhD, MPH
Email: catherine.sinfield@mssm.edu
Tel: 212-241-8655

Core Teams: Regulatory Team
Regulatory Affairs Manager: Nicole Lewis, CCRC
E-mail: nicole.lewis@mssm.edu
Tel: 212-241-0639

Regulatory Compliance Coordinator: Fatoumata Camara, BS
E-mail: Fatoumata.Camara@mssm.edu
Tel: 212-241-9841

Regulatory Compliance Coordinator: Naja Daniels
E-mail: Naja.Daniels@mssm.edu
Tel: 212-241-0059

Regulatory Compliance Coordinator: Lisandra Rivera, ACRP-CP
E-mail: Lisandra.Rivera@mssm.edu
Tel: 212-241-5389

Core Teams: Financial Management Team
Finance Manager: William Benjamin, BS
E-mail: William.Benjamin@mssm.edu
Tel: 212-241-4654

Finance Analyst I: Nicole Gonzalez
Nicole.Gonzalez2@mssm.edu
T
el: 212-241-7454

Business Coordinator: Shakia Cook
E-mail: Shakia.Cook@mssm.edu
Tel: 212-241-7556

Core Teams: Clinical Research Coordinator Team
Research Coordinators Manager: Diana Valerio, BS,CCRC
E-mail: Diana.Valerio@mssm.edu
Tel: 212-241-9538

Clinical Trials Manager: Sari Feldman, MSW
E-mail: Sari.Feldman@mssm.edu
Tel: 212-824-7669

Clinical Research Coordinator: Jonathan Kessler, RN
E-mail: Jonathan.Kessler@mssm.edu
Tel: 212-241-9264

Senior Certified Clinical Research Coordinator: Meredith Lewis, MSW, CCRC
Email: Meredith.Lewis@mssm.edu
Tel: 212-241-8903

Clinical Research Coordinator II: Garnette Mason, MPH, CCRC
E-mail: Garnette.Mason@mssm.edu
Tel: 212-241-4824

Clinical Research Coordinator II: Amy Nolan, BS
E-mail: Amy.Nolan@mssm.edu
Tel: 212-824-7699

Clinical Research Coordinator I: Isabella Perez Pecchio
E-mail: isabella.perezpecchio@mssm.edu
Tel: 212-241-6593

Clinical Research Coordinator I: Lakshmi (Shruti) Mangar, MPA
E-mail: Shanti.Mangar@mssm.edu
Tel: 212-241-0493