IRB Review Analyst - Human Research Protection Office
Washington University in St. Louis
Location: Jefferson City, Missouri
Internal Number: JR64930
The Department of Health and Human Services (HHS) and the Food and Drug Administration have established regulations governing the conduct of human subject research. These regulations mandate that an Institutional Review Board (IRB) review human subject research proposals so as to âœprotect the rights and welfare of human subjects.â The Washington University IRB reviews research involving human subjects conducted by WU faculty/staff. The WU IRB is composed of members of varying background and expertise. These members are responsible for ensuring that human subject research conducted at Washington University meets all applicable ethical, regulatory, and institutional requirements. The Human Research Protection Office supports the activities of the WU IRB.
The IRB Review Analyst plays an integral role in the review of human subject research. Each research study requiring review by a fully convened committee will be thoroughly screened by the IRB Review Analyst to ensure information is accurate, complete and sufficient for the committee to determine if the study is approvable under the guiding regulatory criteria and institutional policies. The IRB Review Analyst will attend committee meetings to document the committeeâ™s meeting actions, deliberations on regulatory and ethical issues and changes to the research plan determined by the committee to be necessary to secure approval. This FTE will communicate the committeeâ™s requirements to the research team and work with the research team in resolving any required actions. This position requires a working knowledge and understanding of complex federal regulations, ethical issues, institutional policies, and other agency requirements governing human subject research.
Primary Duties and Responsibilities
Screen research studies for compliance with federal regulations (including HIPAA compliance) and institutional policies and procedures.Â Identify issues or concerns that must be addressed in order for the committee to review and approve the research.Â Screening activities encompass new submissions, continuing review of studies, amendments, and unanticipated problems.
Serve as a liaison between the committee members and research team.Â When necessary, contact investigators or coordinators to obtain additional information or clarification prior to the committee meeting.
Attend committee meetings and serve as a resource on human subject research regulations and institutional requirements for committee members and Chairs.
Compose meeting minutes that are in compliance with federal regulations and incorporate complex scientific and regulatory language, in addition to relevant ethical concerns.Â Letters must be clear, concise and grammatically correct.
Counsel research faculty and support staff in resolving committee contingencies.Â Once submitted, review responses from investigators and approve protocols (when compliant).
Distribution of minutes for approval by committee members.
Provide educational and directive responses to general human subject questions from WU investigators and research staff.
Provide guidance to WU Investigators and research staff regarding applications in preparation for submission to HRPO.
Maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research.
Serve as a member of the SWAT! Team (Staff with Answers Today).Â SWAT! is a resource that provides an on-call service and office hours to assist investigators, research staff and students with questions about any issue related to IRB review.
Provide back-up and support for coworkers on an as needed basis.
Participate in continuing education in the field of human subject research.Â Opportunities to attend a national conference are also available.
Other duties as assigned.
One to two years of experience in clinical research.
Research coordinator and/or human research regulatory coordinator experience highly desirable.
IRB interaction experience.
Excellent written and verbal communication skills.
Customer service oriented.
General medical knowledge and familiarity with the conduct of research.
Comprehension of and ability to problem solve within the framework of major documents pertaining to Human Subject Protections, including 45CFR46, 21CFR50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report.
Organized and detail oriented.
Capable of handling several tasks/projects at a time and prioritizing responsibilities.
Able to work under deadline pressures.
Comfortable and able to work within an electronic environment.
Working knowledge of HRPO and software applications.
Able to function independently in terms of decision-making and meeting job requirements.
Cooperative and positive attitude.
Bachelorâ™s degree or equivalent combination of education and experience.
One or more years of related work experience.
REQUIRED LICENSURE/CERTIFICATION/REGISTRATION: Successful applicant will be expected to obtain and maintain Certified IRB Professional certification upon meeting eligibility requirements.
$45,800.00 - $75,900.00 / AnnuallyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an 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 is committed to providing a comprehensive and competitive benefits package to our employees. Benefits eligibility is subject to employment status, full-time equivalent (FTE) workload, and weekly standard hours. Please visit our website at https://hr.wustl.edu/benefits/ to view a summary of benefits.
Washington University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to an individualâ™s sex, race, color, religion, age, disability status, protected veteran status, national or ethnic origin, gender identity or expression, sexual orientation. Women, minorities, protected veterans and the disabled are strongly encouraged to apply.
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment â“ fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
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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.