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ICTR The Johns Hopkins Institute for Clinical and Translational Research
Overview of ICTR Research Navigator Supported Services
July 14, 2014ICTR Research Navigators
ICTRNavigator Role
What do the Research Navigators do?
We answer or help get answers to any questions that aninvestigator or study team may have about their researchproject.
ICTR
Carol Kobrin, PhD ICTR Research Studio Director Manager of Navigator Supported Services
Ph.D. in cellular immunology
Thirty-three years experience in biological research
Extensive background in development and testing of investigational human therapies including:
• Eleven years with the NCI developing and testing a cancer vaccine
• Five years with the SKCCC CRO ensuring FDA compliance for investigator sponsored studies
• Five years as Director of the Cell Processing and Gene Therapy Facility at JH
About the Navigators
ICTR
Che Jarrell, BSPH, MPIA, RACICTR Research Navigator
Ten years experience with biomedical product research and development in the pharmaceutical industry with focus on:
• compilation of submissions to the FDA• managing systems to ensure that clinical trials complied with
international standards for patient safety• designing systems for managing and evaluating results from clinical
trials
From 2008-2014, managed Quality Assurance group for the JH SKCCC CRO
Joined Navigator group in March of 2014
About the Navigators
ICTR
Shernice Madison, Navigator Program Coordinator
Joined Navigator group in December 2013
Ten years experience coordinating administrative operations of the General Clinical Research Center (GCRC) and ICTR/Clinical Research Units (CRU) application process
Manages all aspects of the protocol review process from inception of application to review and approval by the Advisory Committee Board
About the Navigators
ICTR
Linda Post, RN, BSN, CCRPICTR Research Navigator
• Eleven years of inpatient and outpatient Oncology nursing in JH SKCCC
• Twelve years as Sr. Clinical Research Nurse in the Division of Hematologic Malignancies at the SKCCCo managed trials focused on HIV and EBV-associated malignancies o experience with biologics IND submissions to FDA and RAC for
several vaccine trials
• Joined the ICTR in 2008 as Research Navigator
About the Navigators
ICTRConnection Request
Click on the blue ‘Connection Request’ button in the bottom ribbon
ICTRConsulting Services/ICTR Programs
‘Ask a Navigator’ ServiceAssists investigators, research teams, and staff with identification ofresources needed for successful completion of pre-clinical and clinicalresearch projects, such as:
• Identification of collaborators• Information about and referral to appropriate ICTR and JHU
services/cores• Identification of possible funding sources• Institutional policies and guidelines for approval and implementation
of both pre-clinical and clinical research• Navigation of institutional committees, offices, and systems• Access to specialized equipment
ICTRConsulting Services /Translational Sciences Cores
Drug and Device Resource Service (DDRS)The ICTR Drug and Device Resource Service (DDRS) provides JohnsHopkins University investigators and project teams access to resourcesneeded to help manage the development and use of investigationaldrugs and devices in clinical research.
Service comprised of:• Assistance with general queries • An investigational drug, biologics, and device information repository• Project specific consultations and support at fee-for-service
ICTRConsulting Services /Translational Sciences Cores
Drug and Device Resource Service (DDRS)
Project Specific Consultations:• A ‘project’ is a single IND or IDE application
• Each individual 'project' receives a complimentary review and analysis(up to 8 hours)
• Navigators determine the regulatory needs of the project
• Provides the investigator with an analysis of the project and potentialpaths forward
• Additional regulatory support from the service at a fee-for-service
ICTRAccelerated Translational Incubator Pilot (ATIP) Program
ATIP is intended to promote innovative, translational research andcross-disciplinary collaborations by providing starter funds forprojects specifically focused on the translation of basic and/or clinicalresearch into new treatments, interventions, or cures that will result inbetter health care.
Available to all JHU faculty members
Special consideration is given to junior investigators and establishedinvestigators moving into a new area of research
Up to $100,000 in direct costs over 12 months
Work closely with Navigators throughout the course of funding period
ICTRNavigator Supported Services
For more information about any of the ICTRcores, programs and services, please see theNavigators at the poster session after thesymposium.
Where science and people connect.
ICTROverview of ICTR Research Navigator
Supported Services
