IRB Administrator

The Human Subjects Division (HSD)has an outstanding opportunity foran IRB Administratorto join their team.

About this Opportunity

The IRB Administrator works under the general direction of the Team Operations Lead (TOL) to support the confidential institutional review and approval of human research activities in which the UW is engaged. The purpose of the review is to protect the safety rights and welfare of research participants 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 UWs compliance with state laws and several different sets of federal regulations with the need tofacilitateresearch and with ethical considerations. This requires high-quality independent conceptual thinking that is aligned with the general perspective of HSD analysis and problem-solving. Daily work involves making judgment calls in ambiguous situations and applying a multi-faceted understanding of the concepts of risk and engagement. Daily contact with researchers requires diplomatic professional andtimelyinteractions based on conciseaccurate and intelligible communication thatalmost alwaysmust be documented in writing.Almost allresponsibilities require extensive reading. The IRB review process uses an electronic web-based system which requires individuals to be comfortable reading on a screen rather than paper and to easily switch back and forth between multiple screens to obtain and synthesize information.

Key Responsibilities

• IRB reviews (40%)

Independently conduct and document expedited IRB reviews of human research (new applications modifications periodic continuing reviews) according to all applicable federal and state criteria for approval as independentlyidentifiedby the reviewer. Includes making decisions about whether waivers of specific regulatory requirements areappropriateand allowable under the applicable regulations.

• Oversight and guidance of IRB committee reviews (15%)

Oversee and guide reviews conducted by the fully convened IRB committee for 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 IRBs expertise; (2) Brief and advise the IRB on the application materials issues and regulatory requirements; (3) Write review letters to the researcher that succinctly accurately and intelligibly communicate the IRBs determinations questions and conditions of approval; (4) Accurately capture for required meeting minutes the IRBs 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 andappropriate whenIRB meeting requirements will not otherwise be met.

• Regulatory determinations (30%)

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 humansubjectsresearch 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 HSDs broader system of education and training and do notgenerally involveindependent development of educational materials and programs outside of that system.

• Other duties as(5%)

Examplesinclude: organizationaleffectivenessactivities;participatingin the development or revision of policies procedures and forms; training interactions with new HSD staff.

Required Qualifications

To be considered for thisopportunityyour application mustdemonstrateyou meet both the minimum qualifications andadditionalqualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements such as a license certification and/or registration.

Minimum Qualifications

Applicants who do not meet these qualifications WILL NOT beforwardedto the Hiring Department.

• Bachelors degree in the sciences healthcare communications or arts & sciences.

• Minimum 4 years relevant applicable work or education experience which may include:

• Human subjects research review/oversight.

• Interaction with human participants as a research staff person.

• Any position involving the application of complex regulatory systems to individuals and work activities.

• Experience with research ethics and methodologies.

Additional Qualifications

The qualities of the successful candidate will include most orall ofthe following:

• comfort with making judgment calls in ambiguous situations;

• highly organized at tracking and prioritizing work;

• outstanding attention to detail;

• ability to write and speak in conciseaccurate and intelligible manner;

• ability to work independently with minimal supervision;

• analytical and problem-solving skills;

• diplomatic and professional interpersonal skills;

• ability to work well as part of a team;

• computerproficiencyincluding MS Word Excel internet browsers and email.Almost allduties require extensive reading/viewing content on multiple screens.

Preferred Qualifications

• Experience working in a higher education setting.

• Familiarity with the research funding process and other research regulatory oversight mechanisms.

• Professional IRB Certification (CIP).

Working Conditions

Individuals may work at the HSD office on the UW Seattle campus 100% remote or a combination (hybrid). The HSD office is a standard open-plan office environmentlocatedin the UW Tower a high-rise office building on the edge of the UW Seattle campus.

• Work schedule and location flexibilityisavailable and encouraged within the boundaries of HSD policy.

• Individuals must provide their own transportation to/from their official residence and their official duty station(s). The UW does provide:

• Frequent free UW shuttles to some (but not all) Seattle locations.

• Free U-PASS that gives an employee unlimited rides on Western WA regional buses commuter trains light rail and water taxis as well as full fare coverage on vanpools.

• The UW does not provide employees with free parking; parking is available at the UW Tower for a fee.

Application Requirement

This recruitment requires a cover letter. Applications that do not include a cover letter willnot beforwardedto the hiring department.

About the Team

HSD is a service and compliance unit within the Office of Research. It reports directly to the Assistant Vice Provost for Research Integrity. HSD and the IRBs it manages perform the federallyconfidential institutional management and review of research activities involving human subjects that are conducted by UW faculty staff and students as well as researchers from a few other local or affiliated institutions. There are about 9500 human research studies atthe UW. The research is remarkably diverse. It is distributed acrossalmost everydepartment and academic unit including the Bothell and Tacoma campuses. It may occur anywhere in the world; a significant percentage of UW research occurs outside of the U.S. The ability of the University to receive grants and to conduct human research depends upon ensuring compliance with federal and state regulations.