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Washington University School of Medicine in St. Louis · 1 day ago

IRB Review Analyst (Remote) - Human Research Protection Office

United States

Full-time

Remote

Entry Level

$50K/yr - $82K/yr

1+ years exp

Washington University School of Medicine in St. Louis is dedicated to ensuring the ethical conduct of human subject research. The IRB Review Analyst will be responsible for screening research studies for compliance with federal regulations, serving as a liaison between committee members and research teams, and providing guidance to researchers regarding applications for HRPO approval.

EducationMedicalUniversities

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

Qualification

Certified IRB ProfessionalHuman Subjects ProtectionsRegulatory ResearchClinical PracticeHealth Insurance Portability & Accountability ActInstitutional Review BoardCooperationCustomer ServiceDeadline ManagementMedical KnowledgeMultitaskingOrganizingPaperless EnvironmentsPositive ThinkingPrioritizationProblem Solving ToolsResearch CoordinationResearchingSoftware ApplicationsStress ManagementWorking IndependentlyDecision MakingDetail-OrientedOral CommunicationsTeamworkWritten Communication

Required

Bachelor's degree or combination of education and/or experience may substitute for minimum education

Certified IRB Professional (CIP) status required when eligible

Relevant Experience (1 Year)

Preferred

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

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.