The University of Washington’s Human Subjects Division (HSD) within the Office of Research, has an outstanding opportunity for a full time IRB Administrator.

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
  
  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.