| Research Integrity Specialist -- New York, NY |
Author: Jon Merz
Date: 04-09-08 11:38
WEILL CORNELL MEDICAL COLLEGE POSITION DESCRIPTION
Position: Research Integrity Specialist
Department: Research and Sponsored Programs
FLSA Status:
Division: Research Integrity
Reports to: Assistant Dean, Research Integrity
I. Position Summary:
Under the direction of the Assistant/Associate Dean for Research Integrity, the Research Integrity Specialist is responsible for the day to day management of all aspects of FDA regulated & clinical research and assisting in the development of policies & procedures related to FDA regulated & clinical research with regard to IACUC, IRB, DSMB, IBC, & financial conflicts of interest.
1. In consultation with the Assistant/Associate Dean and IRB & IACUC Directors, assisting in the development of policies & procedures related to FDA regulated & clinical research with regard to IACUC, IRB, DSMB, IBC, & financial conflicts of interest.
1. Oversees and assists the IRB & IACUC Directors in managing of all aspects of FDA regulated & clinical research.
1. Attending IRB, IACUC, DSMB, IBC, & CTSC meetings on behalf of the Division.
1. Participates in the review for protocols involving FDA regulated & clinical research.
1. Works with IRB members & staff in determining the appropriate level of review of FDA regulated & clinical research, and whether and when external review is necessary.
1. May be appointed to serve on one or both of the WCMC IRBs, IACUC, DSMB, and/or IBC and act as a reviewer for any submissions involving FDA regulated & clinical research.
1. Acts as the liaison between the Division and the WCMC research community on matters relating to FDA regulated & clinical research.
1. Acts as a Divisional liaison to provide assistance and information to the RASP Grants Administrators, Institute for Clinical Research (ICR), and CTSC with regard to FDA regulated & clinical research.
1. Acts as the IRB liaison with the Conflicts Advisory Panel (CAP) to ensure that researchers conducting FDA regulated & clinical research are in compliance with all of the CAP requirements.
1. Coordinating the IRB staff to provide support as necessary to the Assistant/Associate Dean in dealing with cases of research misconduct.
1. Performs other job related duties as required. Occasionally presents at IRB, IACUC, DSMB, IBC, & other educational workshops.
1. Providing guidance to the Research Integrity staff in advising and consulting with investigators and coordinators in all aspects of FDA regulated & clinical research.
1. Ensuring that the Research Integrity boards, committees, and panels consider all necessary regulatory and other considerations in their review of FDA regulated & clinical research both during and outside committee meetings.
REQUIREMENTS:
Mater’s degree in a scientific field required. Minimum of 6 years related experience required, at least 4 of which are directly related to FDA regulated & clinical research. Extensive technical knowledge of FDA regulations, regulatory compliance related to drug & device development, and clinical research is required. Excellent organizational, analytical, and communication skills required; proficient in word processing and database applications. Prior management experience preferred.
To apply, please send cover letter and CV to:
Maureen S. McKeever
Assistant to Dr. Mary C. Simmerling
& Dr. Rosemary Kraemer
Weill Cornell Medical College
425 East 61st Street, Suite 301
New York, NY 10065
Email: msm2002@med.cornell.edu
Tel: 212-821-0577
Fax: 212-821-0580
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Author |
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Research Integrity Specialist -- New York, NY new |
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Jon Merz |
04-09-08 11:38 |
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