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The University of Washington’s Human Subjects Division (HSD) within the Office of Research, has an outstanding opportunity for a full time IRB Administrator.
This recruitment will fill an additional opening.
The IRB Administrator manages and/or conducts the confidential institutional review and approval process of proposed research activities involving human subjects at the University of Washington and some affiliated institutions. The purpose of the review is to protect the safety, rights, and welfare of research subjects and to ensure institutional compliance with federal and state regulations and University policy.
The IRB Administrator must understand many complex regulatory and ethical issues and how they apply to UW research. The position requires balancing the need to assure the UW's compliance with state laws and at least five different sets of federal regulations with the need to facilitate research and with ethical considerations.
IRB reviews Independently conduct and document expedited IRB reviews of human subjects research (new applications, modifications, annual re-reviews), according to all applicable federal and state criteria for approval, as independently identified by the reviewer. Includes making decisions about whether waivers of specific regulatory requirements are appropriate and allowable under the applicable regulations.
Oversight and guidance of IRB committee reviews Oversee and guide reviews conducted by the full convened IRB committee, of research that involves more than minimal risk. For each set of application materials, this includes: (1) Rigorous pre-review screening of all materials and interaction with the research team to identify for the IRB all regulatory issues and determinations; ensure that the materials provide all information required for the IRB to makes its decisions; and identify whether a consultant is needed to supplement the IRB's expertise; (2) Brief and advise the IRB on the application materials, issues, and regulatory requirements; (3) Write review letters to the researcher that quickly, accurately, and intelligibly communicate the IRB's determinations, questions, and conditions of approval; (4) Accurately capture for required meeting minutes the IRB's decisions, determinations, vote tallies, and controverted issues; (5) Verify on behalf of the IRB that its conditions of approval have been met by the research team; and (6) Serve as an alternate voting member of the IRB. This participation is limited to infrequent substitutions as needed and appropriate when IRB meeting requirements will not otherwise be met.
Regulatory determinations Independently make and document numerous required regulatory determinations about proposed research and scholarly activities, including: identification of activities requiring IRB review; identification of which participating groups must be considered human subjects; whether the activity is eligible for use of the UW IRB; required type of IRB review; and identification of all applicable state and federal regulations.
Consultation and training Provide direct consultation, education, and problem-solving through phone calls, in-person meetings, and classroom presentations to UW faculty, research staff, residents/fellows, and students about specific planned research and/or about human subjects research ethics, regulations, and review processes. May include assistance with developing "review-ready" applications and permission/assent/consent forms. Educational activities are delivered as part of HSD's broader system of education and training, and do not generally involve independent development of educational materials and programs outside of that system.
Other duties as required Examples include: organizational effectiveness activities; participate in the development or revision of policies, procedures, and forms; training interactions with new HSD staff.
Bachelor's degree in a field that requires scholarly research. Five years applicable work experience which includes: human subjects review/oversight; interaction with human subjects as a research staff person; or any position involving the application of complex regulatory systems to individuals and work activities. Education and/or work experience must have provided familiarity with research ethics and methodologies. An equivalent combination of education and/or experience may substitute for the stated requirements.
Almost all duties require extensive reading. Within one year, the IRB review process will be entirely conducted via an electronic web-based system, which will require individuals to be comfortable reading on a screen rather than paper and to easily switch back and forth between screens to obtain and synthesize information. The qualities of the successful candidate will include most or all of the following: (1) comfort with making judgment calls in ambiguous situations; (2) highly organized at tracking and prioritizing work; (3) outstanding attention to detail; (4) ability to write and speak in concise, accurate, and intelligible manner; (5) ability to work independently with minimal supervision; (6) analytical and problem-solving skills; (6) diplomatic and professional interpersonal skills; (7) ability to work well as part of a team; (8) computer proficiency including MS Word, Excel, internet browsers, and email.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
CONDITIONS OF EMPLOYMENT:
Application Process: The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.