Expedited Review Specialist (Remote) - Human Resource Protection Office Reserve

Washington University in St. Louis

8d • Remote

About The Position

The Expedited Review Specialist reviews all research involving human subjects conducted by WashU faculty/staff/students and all research conducted at any WashU affiliated institution. This role is an IRB committee member designated to conduct and approve expedited review of biomedical and behavioral research involving human participants.

Requirements

• 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: No specific work experience is required for this position.
• Certified IRB Professional (CIP) status required when eligible.

Nice To Haves

• Education: Master's degree
• Certifications/Professional Licenses: Certified IRB Professional - CIP Council
• Work Experience: Human Subject Research (1 Year), Healthcare (1 Year), Institutional Review Board (Irb), Clinical Trials, Or Healthcare (1 Year), Clinical Trials (1 Year)
• Skills: Adaptability, Business Process Auditing, Clinical Research Coordination, Clinical Trials, Code of Federal Regulations, Detail-Oriented, Health Care, HIPAA Regulations, Human Subjects Protections, Human Subjects Research, Independent Decision-Making, Institutional Review Board (IRB), Medical Knowledge, Microsoft Office, Multitasking, Oral Communications, Public Speaking, Research Compliance, Scientific Research, Written Communication

Responsibilities

• Reviews biomedical and behavioral research studies for compliance with Federal regulations and Institutional (WUSTL/IRB) policies and procedures.
• Identifies issues or concerns that must be addressed in order to approve the research under the expedited procedure. Research reviews will include new studies, modifications to currently approved research, and continuing reviews.
• Provides justification for expedited classification or refer the submission to the full board committee if expedited classification is found not to be appropriate.
• Communicates with investigators to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any. Contingencies (requests for changes or clarifications) should include standard statements from myIRB manual, regulatory guidance and education as applicable. Communications 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 that are preparing IRB applications.
• Provides help services to include an on-call phone line service and Office Hours.
• Consults with other experts as needed to conduct informed, qualitative review of biomedical and behavioral research involving human participants. Experts may include physician-scientists or other clinical professionals, scientists in the social-behavioral-educational sciences, and institutional colleagues in research administration.
• Serves as a primary reviewer and voting member of a convened IRB.
• Serves as a resource for other IRB 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, development of guidance documents and/or quality assurance/improvement assessments.
• Other duties as assigned.

Benefits

• Personal 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 Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
• Family 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