Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Human Research Protection Office. The position is located at the Mid Campus Center. This position is for the Medical School Campus.
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.
Master’s degree preferred.
3 –5 years experience in clinical research and/or IRB experience preferred.
Comprehension of and ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including 45CFR46, 21CFR50,56,
HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report, and the HRPO Policies and procedures.
General medical knowledge and familiarity with the scientific process and research design.
Comfortable making independent decisions within a designated framework.
Detail oriented, including auditing skills.
Ability to manage several projects at once.
Conceptual thinking and the ability to apply knowledge to a variety of situations.
Excellent communication skills, written and oral, including public speaking.
Cooperative and positive attitude.
Enjoys working independently and as part of a team.
Accepts and adapts to changes in office procedures or priorities.
Experience with Microsoft Office Professional software (Word, Access, Excel, Power-Point, Outlook).
Clinical research coordinator and/or human research regulatory coordinator experience.
The hiring range for this position is $51,293 - $66,685 annually.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.