IRB Review Analyst - Human Research Protection Office
Washington University in St. Louis
Location: St. Louis, Missouri
Internal Number: JR61178
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 to âœprotect the rights and welfare of human subjects.â The Washington University Human Research Protection Office (WU HRPO) reviews and monitors all research involving human subjects conducted by WU faculty/staff and all research conducted by any WU-affiliated institution.
The HRPO has eleven IRBs that review research conducted by over 900 WU faculty and staff. Each of the 10 full boards is comprised of 15 to 20 committee members who are responsible for ensuring that WU research meets ethical, regulatory, and institutional requirements. Each committee meets once monthly in the HRPO conference room to conduct review of approximately 10 to 20 agenda items per meeting.
This position is responsible for communicating ethical and regulatory issues discussed at committee meetings to WU investigators who submit research proposals for HRPO approval; this full-time employee will generate letters that address ethical concerns; regulatory issues, and institutional policy and will work with WU researchers in resolving committee contingencies; the 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
Reviews research studies for compliance with federal regulations and institutional (WUSTL/HRPO) policies and procedures; identifies issues or concerns that must be addressed in order for the full board members to review and approve the research (research reviews will include new and continuing review of studies, revisions/amendments, unanticipated problems, etc.).
Composes letters to investigators that incorporate complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any; these letters should include guidance and education as applicable; letters must be clear, concise, and grammatically correct.
Maintains a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research.
Provides guidance to research coordinators and investigators regarding applications in preparation for submission to HRPO.
Consults with other experts as needed to conduct informed, qualitative review of 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, and federal officials).
Serves as a resource for IRB members, research staff, and HRPO staff members.
Performs educational presentations (formal and informal) to HRPO colleagues, to WU research community, and at national meetings of IRB professionals.
Participates in special projects such as creation of submission forms and guidance documents, scientific research for publication, and/or quality assurance / improvement assessments.
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.
Ideal candidate profile is a research coordinator with a working knowledge of the federal regulations governing research, including the HIPAA regulations; comprehension of and ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including the Common Rule, FDA regulations, HIPAA regulations, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report, as well as HRPO policies and procedures.
General medical knowledge and familiarity with the scientific process.
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 â“ 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.
Proficient and comfortable working in an electronic environment.
Bachelorâ™s degree or equivalent combination of education and experience.
One or more years of related work experience required.
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.