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 goal of this committee is to facilitate selection of clinical trials that are safe, scientifically sound, have a high probability of meeting enrollment goals while not competing with concurrent protocols.  The committee conducts a thorough review of the protocol’s scientific rationale, objectives and hypothesis, study design, resources, safety, biostatistical design, and finances.  Every clinical trial across the Mount Sinai Health System for the Department of Medicine is reviewed and evaluated. We conduct meetings 2 times per month. Department of Medicine Faculty members from all campuses serve on each committee. The Principal Investigator works closely with the CTO director for preparation of the application. For more information please contact Michele Cohen at 212-241-7734.

PRC Members Non-Voting Members

  • Michele Cohen, MS, CCRC
  • Shanika Gregory
  • Jennifer Lee
  • Nicole Lewis, CCRC
  • Juan Wisnivesky, MD, DPh

Committee 1

  • Jeanine Albu, MD
  • Charissa Chang, MD
  • Jean-Frederic Colombel, MD
  • Donna Mildvan, MD
  • Michael Mullen, MD
  • Charles Powell, MD
  • Neil Schachter, MD
  • Jonathan Winston, MD

Committee 2

  • Yousaf Ali, MD
  • Paula Busse, MD
  • Douglas Dieterich, MD
  • Eliza Geer, MD
  • Nicolas Harbord, MD
  • Robert Klein, MD
  • Vijay Lapsia, MD
  • Maria Padilla, MD
  • Bruce Sands, MD

The CTO office has conducted over 450 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. Current Distribution of Clinical Trials in the Department of Medicine CTO (9/30/14) Active Protocols by Division

Research Experience

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

  • Asthma
  • Autoimmune Hepatitis
  • Chronic Obstructive Pulmonary Disorder
  • Crohn's Disease
  • Cushing’s Disease
  • Drug Induced Liver Disease
  • Hepatitis B Virus
  • Hepatitis C Virus
  • Hereditary Angioedema
  • Human immunodeficiency virus (HIV)
  • Irritable Bowel Disease
  • Lupus Erythematosus
  • Nonalcoholic Steatohepatitis (NASH)
  • Pulmonary Fibrosis
  • Rheumatoid Arthritis
  • Sarcoid
  • Ulcerative Colitis

Research Staff

  • 7 full-time research coordinators
  • IATA Certified Staff
  • Experience using various platforms for Electronic Data Capture         
  • Current Investigators

Diagnostic/Clinic Equipment

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

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

Medical Director: Juan Wisnivesky, MD, DrPH
Tel: 212-824-7567

Director: Michele Cohen, MS, CCRC
Tel: 212-241-7734

Core Teams: Regulatory Team
Regulatory Affairs Manager: Nicole Lewis, CCRC
Tel: 212-241-0639

Regulatory Compliance Coordinator: Zaira Mejia
Tel: 212-241-0059

Regulatory Compliance Coordinator: Lisandra Rivera
Tel: 212-241-5389

Core Teams: Financial Management Team
Finance Manager: Jennifer Lee
Tel: 212-241-4654

Core Teams: Clinical Research Coordinator
Research Coordinators Manager: Shanika Gregory
Tel: 212-659-8375

Clinical Trials Manager: Sari Feldman, MSW
Tel: 212-241-4028

Senior Clinical Research Coordinator: Elizabeth Baez, MA, CCRC
Tel: 212-241-8903

Senior Certified Clinical Research Coordinator: Arika Manapat MS, CCRC
Tel: 212-241-9264

Senior Clinical Research Coordinator: Susana Seijo, MD, PhD
Tel: 212-241-1617

Clinical Research Coordinator II: Shruti Sharma, MA
Tel: 212-241-0493

Clinical Research Coordinator II: Diana Valerio, BS
Tel: 212-241-9538