IRB Review Analyst (Remote) - Human Research Protection Office

Washington University in St. Louis • St. Louis, MO

1d • Remote

About The 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 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.

Requirements

• Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
• Relevant Experience (1 Year)
• Certified IRB Professional (CIP) status required when eligible.

Nice To Haves

• 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.
• Master's degree
• Certified IRB Professional - CIP Council
• Clinical Research (1 Year)
• Cooperation
• Customer Service
• Deadline Management
• Decision Making
• Detail-Oriented
• Good Clinical Practice (GCP)
• Health Insurance Portability & Accountability Act (HIPAA)
• Human Subjects Protections
• Institutional Review Board (IRB)
• Medical Knowledge
• Multitasking
• Oral Communications
• Organizing
• Paperless Environments
• Positive Thinking
• Prioritization
• Problem Solving Tools
• Regulatory Research
• Research Coordination
• Researching
• Software Applications
• Stress Management
• Teamwork
• Working Independently
• Written Communication

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.
• Perform other duties as assigned.

Benefits

• Up to 22 days of vacation, 10 recognized holidays, and sick time.
• Competitive health insurance packages with priority appointments and lower copays/coinsurance.
• Take advantage of our free Metro transit U-Pass for eligible employees.
• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.
• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level