IRB Review Analyst (Remote) - Human Research Protection Office

Scheduled Hours 40 Position Summary 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 “protect the rights and welfare of human subjects.” The WashU 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.

Job Description

Primary Duties & Responsibilities:

• Screen research studies for compliance with federal regulations (including HIPAA compliance) and institutional policies and procedures. Identify issues or concerns that must be addressed in order for the committee to review and approve the research. Screening activities encompass new submissions, continuing review of studies, amendments and unanticipated problems.
• Serve as a liaison between the committee members and research team. 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. Letters must be clear, concise and grammatically correct.
• Counsel research faculty and support staff in resolving committee contingencies. Once submitted, review responses from investigators and approve protocols (when compliant).
• Distribute 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). 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. Opportunities to attend a national conference are also available.
• Perform other duties as assigned. Working Conditions: Job Location/Working Conditions:
• Normal office environment. Physical Effort:
• Typically sitting at desk or table.
• Typically standing or walking.
• Occasional lifting (25 lbs. or less). The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education: Bachelor’s degree or combination of education and/or experience may substitute for minimum education. Certifications/Professional Licenses: No specific certification/professional license is required for this position. Work Experience: Relevant Experience (1 Year) Skills: Not Applicable Driver's License: A driver's license is not required for this position. More About This Job Required Qualifications:

• Certified IRB Professional (CIP) status required when eligible. Preferred Qualifications:
• Working knowledge of HRPO.
• 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.

Preferred Qualifications

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