IRB Administrator

University of Washington Medical Center•Seattle, WA

3d•$79,704 - $91,932•Hybrid

About The Position

The Human Subjects Division (HSD) has an outstanding opportunity for an IRB Administrator to join their team. 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.

Requirements

Bachelor’s 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.
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 concise, accurate, 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
Computer proficiency including MS Word, Excel, internet browsers, and email.
Almost all duties require extensive reading/viewing content on multiple screens.

Nice To Haves

Experience working in a higher education setting.
Familiarity with the research funding process and other research regulatory oversight mechanisms.
Professional IRB Certification (CIP).

Responsibilities

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.
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: 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; Brief and advise the IRB on the application materials, issues, and regulatory requirements; Write review letters to the researcher that succinctly, accurately, and intelligibly communicate the IRB's determinations, questions, and conditions of approval; Accurately capture for required meeting minutes the IRB's decisions, determinations, vote tallies, and controverted issues; Verify on behalf of the IRB that its conditions of approval have been met by the research team; and 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.
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.
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.
Organizational effectiveness activities; participating in the development or revision of policies, procedures, and forms; training interactions with new HSD staff.