Mission
To lead clinical trials that push the boundaries of discovery for a healthier tomorrow.
Vision
To support the Johns Hopkins community as a trusted gateway to clinical trials through customer-centric leadership, robust infrastructure, and harmonized processes.
Message from the Senior Associate Dean for Clinical Trials and Capital Region Research
Welcome to the Johns Hopkins Office of Clinical Trials! I'm Dr. Mark Sulkowski, Professor of Medicine in the Division of Infectious Diseases, Department of Medicine, and the Senior Associate Dean for Clinical Trials and Capital Region Research in the School of Medicine. I'm thrilled to partner with Dr. Gail Daumit, the Vice Dean for Clinical Investigation, and Dr. Daniel Ford, director of the John Hopkins Institute for Clinical and Translational Medicine (ICTR) to transform the Johns Hopkins Medicine clinical trials ecosystem.
As an academic clinical investigator, I've partnered with colleagues at Johns Hopkins, other academic institutions, government agencies, and industry to lead clinical trials that revolutionized the treatment of people with chronic hepatitis C infection. These partnerships made a remarkable difference for people with hepatitis C by delivering curative treatment with minimal side effects. Clinical trials are central to ensuring that we improve the health of our patients and our population by advancing innovative therapies and strategies for the diagnosis prevention and treatment of disease.
The Johns Hopkins Office of Clinical Trials is a service organization committed to enabling John Hopkins clinical investigators and our patients to improve human health by pushing the boundaries of discovery through clinical trials. We're here to help and look forward to partnering with you!
What's New?
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Johns Hopkins Medicine officially launched the OnCore Clinical Trial Management System on October 5, 2023, with Sprint 1 go-live, which brought Oncology and a few selected non-oncology clinical trials onto the new platform. Of course, this was just the first step in our journey toward full OnCore implementation and integration. We’re looking ahead to April 2024, when all Johns Hopkins clinical research teams will begin using OnCore.
Make sure you sign up for upcoming training here: OnCore Training Catalog and review additional OnCore Resources
For additional information, newsletters, and training about OnCore visit: JHM Research Hub and sign up for the monthly newsletter.
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Fibi is the recently launched web-based grants management system, replacing the previous system, COEUS. Fibi's modular structure simplifies collaboration among researchers, administrators, and sponsors while maintaining strict adherence to government and institutional policies. For additional information and training resources, please visit: https://oris.jhu.edu/
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Medasource is a Clinical Research consulting and support firm partnering with over 150 leading research institutions, health systems, academic medical centers, and pharmaceutical companies. Their flexible & shared sourcing model provides solutions specific to team/department needs. Medasource provides short-term and long-term support in the following areas:
- Research administration (pre and post award)
- Clinical Trial Project Management
- Clinical Trial Contracts and Finance
- Regulatory compliance
- Medical and Scientific writing
- Data management
- Other
For more information, see workflow here. If you are interested to utilize Medasource for staffing or other purposes please contact the OCT at [email protected].
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Greenphire ClinCard is a simple, secure, fast way to pay and reimburse study participants.
ClinCard Study Coordinator and Approver training is available in MyLearning.
ClinCard resources for clinical research staff and administrators are available on the SAP Training website SAP Training for ClinCard.
More information on this program
Questions? Email [email protected] and [email protected]
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The Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program provides guidance to clinical investigators, sponsors, and sponsor-investigators regarding the process to secure institutional approval to serve in the role of sponsor-investigator and submit an application for an IND or IDE to the FDA in accordance with the institutional policy on Investigator-held INDs/IDEs.
For more information or questions: [email protected]
Newsroom
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We are excited to present the latest installment of the Office of Clinical Trials Newsletter. Read More
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Excitement is on the horizon as we gear up for Clinical Trials Day 2024. Mark your calendars for Saturday, May 11th for the CTD Community Event and Monday May 20th for CTD at all JHM sites and join us for a day of discovery! #CTD2024
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On December 8, 2023, the Office of Clinical Trials (OCT) held its second annual retreat at the Johns Hopkins Carey Business School. Dr. Antony Rosen, Vice Dean for Research was our keynote speaker, while Drs. Max Konig, Assistant Professor in the Division of Rheumatology and Paul Brunetta, Senior Vice President of Clinical and Translational Science at Sana Biotechnology and Adjunct Associate Professor in the Pulmonary and Critical Care Division at University of California, San Francisco participated as invited guest speakers. Additionally, Drs. Sashank Reddy, Associate Professor of Plastic and Reconstructive Surgery, and Medical Director of Johns Hopkins Technology Venture and Steve Harr, President and Chief Executive Officer of Sana Biotechnology joined our invited speakers as panelist for an open discussion the role of academic medical centers in clinical development of novel therapeutics.
Quick Links
Mark Sulkowski
Senior Associate Dean for Clinical Trials and Capital Region Research
Marian De Backer
Director, Office of Clinical Trials
Jackie Lobien
Director, Clinical Research Program Operations and Capital Region Research (CAPRES)
Mont Brownlee
Executive Director, Clinical Research Contracting
Karen Roz
Senior Director, Clinical Research Support Service
Liza Rodriguez
Associate Director, Clinical Research Billing Compliance (CRBC)
Eva Zimmerman
Director, Johns Hopkins University IND/IDE Program
Scott Streibich
Director, Clinical Research Revenue Cycle
