PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) regulations mandate that institutions receiving federal research funds maintain an Institutional Review Board (IRB) to review all human subject research proposals so as to “protect the rights and welfare of human subjects.” The Washington University (WU) IRB, Human Research Protection Office (HRPO), reviews and monitors all research involving human subjects conducted by WU faculty/staff and all research conducted at any WU affiliated institution.
This position is an IRB committee member designated to conduct and approve expedited review of biomedical and behavioral research involving human participants. Like review by the convened IRB, expedited review must fulfill all the requirements of review according to applicable HHS and FDA regulations.
PRIMARY DUTIES AND RESPONSIBILITIES:
Review biomedical and behavioral research studies for compliance with Federal regulations and Institutional (WUSTL/HRPO) policies and procedures. Identify issues or concerns that must be addressed in order to approve the research under the expedited procedure. Research reviews will include new and continuing review of studies, modifications, etc.
Provide justification for expedited classification or refer the submission to the full board committee if expedited classification is found not to be appropriate.
Communicate with investigators (via telephone, myIRB and in person) to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any. Contingencies (requests for changes or clarifications) should include standard statements from myIRB manual, regulatory guidance and education as applicable. Communications must be clear, concise, and grammatically correct.
Maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research.
Provide guidance to research coordinators and investigators regarding applications in preparation for submission to HRPO, via myIRB, SWAT on call and office hours.
Consult with other experts as needed to conduct informed, qualitative review of biomedical and behavioral research involving human participants. Experts may include physician-scientists or other clinical professionals, HRPO colleagues and scientists in the social-behavioral-educational sciences, HRPO and Institutional colleagues in research administration.
Serve as a primary reviewer and voting member of a convened IRB.
Serve as a resource for other IRB members.
Perform educational presentations (formal and informal) to HRPO colleagues, to WU research community, and at national meetings of IRB professionals.
Participate in special projects, development of guidance documents, and/or quality assurance/improvement assessments.
Other duties as assigned.
Bachelor’s degree is required.
Must have working knowledge of the federal regulations governing research, including the new HIPAA regulations
Internal Number: 50607
About Washington University in St. Louis
Founded in 1853, Washington University in St. Louis is nationally and internationally renowned for teaching, learning, research, service to society, and patient care with highly ranked schools spanning arts and sciences, architecture and fine arts, business, engineering, law, social work, and medicine. Today the university has more than 15,000 undergraduate and graduate students, 3,800 faculty, and 15,400 total employees. The university’s annual operating budget is over $3.0 billion and has an endowment of $7.2 billion.
Positioned to meet imperatives confronting the nation and the world, Washington University takes its responsibility seriously. Through innovative research, the university is committed to creating the new knowledge necessary to achieve a bright and sustainable future. During the 2017 fiscal year, grants and contracts totaling more than $643 million supported faculty research efforts across all schools of the university with more than 3,000 research projects underway each year. The Washington University School of Medicine is one of the largest recipients of funding for research and training from the National Institutes of Health, with the majority of the funds awarded for research in cancer, diabetes, cardiovascular disease, infectious disease and genomics.