Clinical Research Resource

The Clinical Research Resource aims to 1) provide dedicated, institution-supported space and staff to support clinical and translational research, 2) enhance regulatory knowledge and support to improve compliance, and 3) provide project-specific support to streamline recruitment, collaboration, ethical considerations, and other aspects of study start up and management.

Access the Clinical Research Resource

Research Project Navigation Tool

The “Research Project Navigator” is designed for staff at all levels, and provides a guide to research activities throughout the project lifecycle. It is organized into 5 key sections: Education & Training, Planning & Development, Project Setup or Initiation, Project Management, and Close Out. This tool guide details the contents of each section to help users efficiently access needed information.

Within each key section users will find all relevant topic areas. Each topic includes a summary of its importance, related requirements (federal regulations, institutional policies, etc.), best practice tips, “how to get started”, and related tools and resources.

The included toolkit provides quick links to policies, standard operating procedures, forms, applications/systems and other helpful resources. Upcoming events and ‘news and highlights’ are also featured on this page.

This video tutorial provides an introduction to the tool.

Have questions? Contact us at HSRprojectnavigation@einsteinmed.edu

Clinical Research Center

Two clinical research units are available for adult and pediatric patient-oriented research. Resources available include skilled nursing and support staff, procedure suites for intensive protocols, well-equipped examination and consultation rooms, laboratory space, and a full kitchen to accommodate nutrition and diabetes studies. Click here to learn more.

Locations

Einstein Campus - Van Etten Building, 4th Floor, B Wing — Einstein Campus - Van Etten Building
4th Floor, B Wing

Montefiore Campus- Moses Research Pavilion, 4th Floor — Montefiore Campus- Moses Research Pavilion
4th Floor

Have questions? Contact Elizabeth Castro, Administrative Director at Elizabeth.castro@einsteinmed.edu or 718-920-5126.

Office of Clinical Trials

The Office of Clinical Trials (OCT) is the central administrative office for privately funded research for Montefiore Medical Center and Albert Einstein College of Medicine. OCT assists the research community with pre and post award management and offers a number of services including education and training, contract and budget development, negotiation and approval, project financial management, business development and administration of an array of research technology tools.

Contact oct@montefiore.org or 718-920-2000 with any inquiries.

Recruitment Consultations

Recruitment and enrollment of volunteers has been identified as the single biggest obstacle impacting the ultimate success or failure of a clinical trial. Study teams have access to a variety of resources to support their unique project needs and target population.

Access available resources in the Research Project Navigation Tool's Planning and Development Section > Recruitment. Here you will find related IRB-submission templates and best practice guidance documents to support your recruitment and retention activities.

To request a comprehensive consultation please contact Zoe Tsagaris at Zoe.tsagaris@einsteinmed.edu or 718-430-8804.

Spanish Translation Resource

This resource supports clinical trial document translation to Spanish and other languages through the Community Engagement Core.

Any research-related document translation requests (i.e., IRB approved consent forms, questionnaires, brochures, flyers, recruitment letters, Web site contents, etc.) must be submitted through the Community Engagement Portal. Fees may apply.

Contact Yovana Coupey at yovana.coupey@einsteinmed.edu with any questions before getting started.

Regulatory Knowledge and Support

FDA-Regulated Project Support

We offer comprehensive consultations for investigators pursuing Investigational New Drug (IND) Applications or Investigational Device Exemptions (IDE). We encourage you to reach out early in the planning and development process so we can establish the most efficient and effective plan for your project.

Resources:

Educational Offerings available on Montefiore’s eLearning (intranet):

Investigational New Drug Applications [Course #1306167]
IDEs and Investigational Device Studies: An Introduction [Course #1307027]
IDE Expanded Access and Humanitarian Use Devices [Course #1306178]
IDEs and Investigational Device Studies: Special Considerations [Course #1307031]

To request a consultation please contact Zoe Tsagaris at Zoe.tsagaris@einsteinmed.edu or 718-430-8804.

ClinicalTrials.gov

ClinicalTrials.gov is a public registry established by federal mandate as a means to provide public access to information on clinical trials for a wide range of diseases and conditions. Registration and, for certain studies, results reporting are required by regulatory and funding agencies.

Data entry and record updates for ClinicalTrials.gov are managed through the Protocol Registration and Results Reporting System (PRS).

To request a user account or assistance please contact clinicaltrials.gov@einsteinmed.edu.

This Comprehensive guide highlights tips for getting started and maintaining your trial record. Access other training resources, related policies and more here.

Educational Offerings available on Montefiore’s eLearning (intranet):

ClinicalTrials.gov Introduction [Course #1306169]

BERD House

This is an online biostatistics resource which includes tools to prepare data sets and compute summary statistics, run basic and advanced statistical tests, design experimental and clinical studies, and download free software. Virtual office hours are offered weekly, with on-campus support available by appointment.

Access the Clinical Research Resource

Leadership

Matthew K. Abramowitz, M.D., M.S.

Director, Clinical Research Resource
Minka Chikolareva R.N., B.S.N., M.S., M.B.A.

Clinical Staff Director
Elizabeth Castro

Operations Director
K. Zoe Tsagaris M.S., OTR/L

Administrative Director