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University of Washington IRB ADMINISTRATOR in Seattle, Washington

Req #: 205945

Department: HUMAN SUBJECT DIVISION

Posting Date: 04/29/2022

Closing Info: Open Until Filled

Salary: Salary is commensurate with experience and education

Shift: First Shift

Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academi-staff-20210208.pdf)

As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world. UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty. The values of diversity, equity and inclusion are integral to the success of our research enterprise and are embedded in the culture of who we are as an institution and employer. We create progressive change honoring the unique and diverse perspectives in the Office of Research and the UW research community. We strengthen our commitment to the core values of diversity, equity, and inclusion by fostering an environment of authenticity in support of our mission to provide an equitable and accessible community to all. Read more here: https://www.washington.edu/research/or/office-of-research-diversity-equity-and-inclusion/ The Human Subject Division has an exciting opportunity for a IRB Administrator to join the team. 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. RESPONSIBILITIES: IRB reviews (40%) 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 (30%) • 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 (15%) • 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 (10%) • 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 (5%) • Examples include: organizational effectiveness activities; participate in the development or revision of policies, procedures, and forms; training interactions with new HSD staff. REQUIREMENTS: • Bachelor's degree in a field that requires scholarly research. • 5 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. 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. DESIRED: • A Master's Degree in a field that requires scholarly research and two years applicable work experience. • This position requires a person who is skilled in interpersonal relationships and oral and written communication, and who is able to deal with high volumes and rigid deadlines. • Professional IRB Certification is desired. Working Environmental Conditions: Individuals may work at the HSD office on the main UW campus, 100% remotely, or a combination (hybrid). The HSD office is a standard open-plan office environment. It occupies parts of two floors in the UW Tower, a high-rise office building on the edge of campus. Work schedule flexibility is available and encouraged. Meetings and in-person presentations may occasionally be required on campus or at some locations away from the main campus (e.g., Harborview, Fred Hutchinson Cancer Center, South Lake Union, the Bothell campus, and the Tacoma campus). Individuals must provide their own transportation, which can include walking, bus, use of frequent free UW shuttles to some locations or (infrequently) driving. The UW does not provide employees with free parking; parking is available at the Tower for a fee, and subsidized transit passes are available. Some work schedule flexibility is available and encouraged. 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.

University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.

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