IRB Administrator

Job Description

The Human Subjects Division (HSD) has an outstanding opportunity for an IRB Administrator to 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 UW's compliance with state laws and several different sets of federal regulations with the need to facilitate research 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, and timely interactions based on concise, accurate, and intelligible communication that almost always must be documented in writing. Almost all responsibilities 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 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 (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 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 succinctly, 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 (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 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; participating in the development or revision of policies, procedures, and forms; training interactions with new HSD staff.

Required Qualifications

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, suc