This position is full-time and works approximately 40 hours per week.
Department Name/Job Location
This position is in the Department of Human Research Protection Office (HRPO). The position is located at 22 North Euclid, in the Central West End. This position is for the Medical School Campus. Normal office working conditions.
The Manager of Expedited Review is responsible for assuring WU compliance with Federal regulations and institutional policies and procedures with respect to expedited review and managing the expedited review team comprised of 7 Expedited Review Specialists. This FTE and the Expedited Reviewers are full board IRB committee members designated by the chair to conduct expedited review. Like review by the convened IRB, expedited review must fulfill all the requirements of review found in the Common Rule and the FDA if applicable.
The WU HRPO Manager of Expedited Review is responsible for overseeing the Expedited Review component to assure the efficient and effective oversight of human subject research in accordance with the Federal regulations. Key responsibilities include management of designated staff, ongoing enhancement of policies and procedures, supporting HIPAA compliance in research, and responding to inquiries from the research community
1. Maintain quality assurance mechanisms, e.g. accuracy of documentation, timely response to submissions, appropriate application of regulations and policy.
2. Responsible to interview and hire for vacant positions within area of responsibility.
3. Supervise orientation of new employees and provide for ongoing training, and continuing education to assure compliance with evolving federal regulations, guidelines, and institutional policies and procedures.
4. Prepare position descriptions, performance evaluations, disciplinary actions, leave records and recommendations for salary increases for direct reports.
5. Be a resource to the expedited review team to discuss difficult review decisions.
6. Act as an expedited reviewer as needed
7. Provide a HRPO point of contact for the research community.
8. Counsel investigators regarding appropriate study design and conduct.
9. Provide assistance to coordinators regarding appropriate application forms and information needed for review.
10. Receive and examine concerns raised by Expedited reviewers, QA/QI Monitors, or research team members.
11. Attend committee meetings to guide volunteer IRB members and perform full board review as a voting member of the IRB.
12. Perform educational presentations (formal and informal).
1. Assist in the creation and updating of HRPO documents including submission forms, guidelines, policies and procedures.
2. Participate in scientific research for publication, and/or quality assurance/improvement assessments.
3. Collaborate with the Manager of Operations, Manager of Full Board Review, and the Associate Director.
4. Other duties as assigned.
Master’s level degree required, or Bachelor’s degree with comparable research and management experience. Background in human subject research or research administration required, direct IRB experience preferred. Certified IRB Professional (CIP) status required when eligible.
1. Strong independent decision making
2. Management and administrative capabilities
3. Ability to manage several projects at once
4. Medical knowledge and familiarity with the conduct of research
5. 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
6. Conceptual thinking and the ability to apply knowledge to a variety of situations
7. Organizational skills
8. Excellent communication, written and verbal, as well as the capacity to speak in front of large groups and communicate with a broad audience including: faculty, research coordinators, institutional officials, and departmental staff.
9. Cooperative and positive attitude to contribute to the team
10. A working knowledge of Microsoft Office software.
11. 1 year supervisory experience preferred
12. Direct IRB experience preferred.
13. 2-3 years experience in human subject research or research administration
The hiring range for this position is $56,222 to $73,091 annually.
-Retirement Savings Plan
-22 vacation days
-8 Paid Holidays
-Tuition benefits for employee, spouse and dependent children
-Free Metro Link/ Bus pass
-Free Life Insurance
-Health, Dental, Vision
-Health Savings Accounts (HSA)
-Long Term Disability Insurance
-Flex Spending Plan
Med School HR website (http://medschoolhr.wustl.edu)
Washington University in St. Louis is an equal opportunity, affirmative action employer and encourages applications from women, ethnic minorities, veterans, and individuals with disabilities.
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