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University of Washington

REGULATORY COORDINATOR

University of Washington, Seattle, Washington, us, 98127


If you are using a screen reader and experience any difficulty accessing our web pages, please call 206-543-2544 or email UWHires and we will be happy to assist you.Department:

DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGYJob Location:

Seattle - OtherPosting Date:

06/26/2024Closing Info:

Open Until FilledShift:

First ShiftBenefits:

As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website.Position Purpose:

The University of Washington's Division of Medical Oncology includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 25 years, members of the Division have developed the world's leading bone marrow transplant program and made substantial contributions to cancer treatment. Our Division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.This position is one of three who will provide regulatory support to the UW Hematologic Malignancies Research Program, overseeing submission and reporting to regulatory agencies, including the Institutional Review Board, FDA, and others.Position Complexities:

This position requires independent judgment and expert knowledge of clinical trial healthcare regulatory operations to facilitate workflow and promote collaboration. The position will maintain communication with study investigators and research staff, and will be supervised by the Clinical Research Program Manager.Knowledge, Skills and Abilities:• Expert knowledge of FDA, International Conference on Harmonization, Code of Federal Regulations, and Good Clinical Practice policies and guidelines as they relate to conduction of human clinical trials.• Strong organization, communication, and interpersonal skills.MINIMUM REQUIREMENTS:• Bachelor's Degree in life or social sciences or related field.• A minimum of 2 years regulatory affairs or research coordination experience.ADDITIONAL REQUIREMENTS:• Sound knowledge of IRB submission procedures, FDA, GCP, and NIH requirements relating to research involving human subjects.• Strong computer skills and competency with Microsoft Office software.WORKING CONDITIONS:Sitting at desk for the majority of hours worked; working on a computer and on the telephone in a public area. Work hours frequently exceed 40 hours per week and may be deadline dependent.Application Process:

The application process for UW positions may include completion of a variety of online assessments. Please note that your application will not be reviewed until all required

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