IRB Review Analyst (Remote) - Human Research Protection Office

Scheduled Hours 40 Position Summary The IRB Review Analyst will attend committee meetings to document the committee’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 role will communicate the committee’s requirements to the research team and work with the research team in resolving any required actions.

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. Education: Required Qualifications 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. Required Qualifications: More About This Job
• Certified IRB Professional (CIP) status required when eligible. Education: Preferred Qualifications Master's degree Certifications/Professional Licenses: Certified IRB Professional - CIP Council Work Experience: Clinical Research (1 Year) Skills: 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 Grade G10 Salary Range $49,700.00 - $82,100.00 / Annually The 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. Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email [email protected] or call the dedicated accommodation inquiry number at 314-935-114