Washington University of St. Louis Human Research Protection Office (HRPO) in St. Louis, Missouri
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location
This position is in the Human Research Protection Office (HRPO). This position is for the Medical School Campus.
The Senior Administrative Analyst is responsible for initiating the IRB review process through triage and screening of all applications submitted in the myIRB data management system. The position coordinates the conduct of IRB meetings, acts as key liaison to other committees in the Human Research Protection Program, and communicates with and provides consultation for WUSTL investigators and research team members regarding HRPO requirements and applicable regulations and policies. The position is responsible for analyzing requests for IRB oversight of non-employees to research protocols before final institutional determination by the HRPO Executive Director. This position requires excellent analytic and interpersonal skills and independent judgment.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Acting as an IRB member, review and provide expedited approval of designated IRB applications.
- Screen and triage all incoming submissions for accuracy, completeness, and compliance with institutional policies (approximately 19,000 applications/year.) Determine whether each application meets federal regulatory requirements for full board or expedited review based on type of research and working knowledge of FDA, OHRP, and HIPAA federal regulatory requirements as well a HRPO policies/procedures.
- Analyze requests by investigators for IRB oversight of non-employees participating in the conduct of the research at Washington University and work with research team to obtain appropriate documentation and information for final determination and institutional signature of the HRPO Executive Director.
- Determine and manage reviewer assignments (primary and secondary) for IRB meetings based on reviewer expertise and research area and/or participant populations in compliance with federal regulatory requirements.
- Determine quorum requirements for each IRB meeting in compliance with federal regulatory requirements and monitor regulatory quorum requirements during IRB meetings.
- Communicate with PIs and research staff regarding HRPO standard operating procedures, such as application and review process, education requirements, renewal/closure notices, etc.
- Determine whether HRPO requirements for review by ancillary committees has been met and act as liaison to those committees including Radiation, Biosafety, Cancer, Conflict of Interest, Stem Cell, and others as appropriate.
- Serve as a resource and the HRPO liaison for full board committee members outside of meetings.
- Screen and identify studies that meet HRPO criteria for referral to the Study Initiation Program conducted in collaboration with Office of Vice Chancellor for Research.
- Act as technical expert in support of myIRB including leading navigation of system during the convened IRB meetings.
- Conduct final review of approved applications in myIRB prior to release to investigator for initiation of studies.
- Generate and maintain the assignments for HRPO’s SWAT (Staff With Answers Today) on-call service, and monthly activity reports related to processing of applications and committee activities.
- Create and maintain Standard Operating Procedures related to position responsibilities.
- Additional duties and special projects as assigned.
Bachelor’s degree or equivalent experience.
- Master’s degree or equivalent experience
- Experience with human subjects research and/or working with an Institutional Review Board or other equivalent regulatory review body
- Strong analytic skills and ability to use discretionary judgment
- Ability to comprehends Federal/Institutional policies and apply requirements appropriately
- Ability to communicate in a professional manner with investigators, coordinators, reviewers, and community members (verbal and written)
- Organized and detail oriented
- Capable of handling several tasks/projects at a time and prioritizing responsibilities
- Able to work under deadline pressures and successfully complete tasks within these deadlines
- Comfortable and able to work within an electronic (paperless) environment
- Working knowledge of Microsoft Office software
- Cooperative and positive attitude and able to function collaboratively within a team environment
- Accepts and adapts to changes in procedures or priorities as determined by manager or changes within the office polices and/or procedures
The hiring range for this position is $43,202 - $55,037 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 (medschoolhr.wustl.edu)
Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
Job Title: Senior IRB Administrative Analyst - Human Research Protection Office (HRPO) - 42155
Job ID: 42155
Location: Medical School
Full/Part Time: Full-Time