IRB Analyst I
About The Position
The IRB Analyst I provides floating support for the University’s 9 IRB committees. The position manages administrative activities of an IRB committee. This position is responsible for the screening of full board and minimal risk protocols as assigned. This position works with research staff to resolve issues related to IRB actions as well as to provide guidance on issues related to IRB review. This position supports meeting agenda preparation, attends convened meetings of the IRB, and maintains thorough and complete notes on the discussion. This position prepares complete and accurate minutes of the meeting. The IRB Analyst I prepares written correspondence to investigators of all IRB actions and decisions. This position liaises between IRB members and investigators. This position supports the maintenance of IRB agendas, minutes, IRB rosters, and all other required regulatory documents in compliance with federal regulations, institutional policies, and IRB SOPs. This position performs other duties and responsibilities as assigned.
Requirements
- Bachelor's and 2 to 3 years of experience or equivalent combination of education and experience is required.
- At least 1 year of experience and knowledge directly related to regulatory review of research or equivalent combination of experience and education (typical experience might include ethics, clinical trial performance, or experience in an academic IRB).
- Must be able to work independently with minimal supervision.
- Knowledge of applicable regulations related to the IRB.
- Outstanding organizational skills and the ability to function in a team environment are required.
- Excellent written and verbal communication skills.
- Advanced computer software skills.
- Customer service mindset.
- The ability to build and maintain positive working relationships at all levels of the institution.
Responsibilities
- Works as a floater, supporting other IRB Administrators / Analysts with administrative activities of the University’s 8 committees.
- Screens submissions assigned to the convened IRB for completeness.
- Attends convened meetings of the IRB and maintaining thorough and complete notes on the discussion 1-2 times per month.
- Prepares complete and accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in or disapproving research, and a written summary of controverted issues and their resolution.
- Prepares written correspondence to investigators of all IRB actions and decisions.
- Works with researchers and research staff to resolve issues related to convened IRB or expedited IRB review.
- Prepares the meeting agenda, as needed.
- Assigns scientifically appropriate protocols to IRB members to review, as needed.
- Conducts IRB member trainings, as needed.
- Supports the IRB Administrators and Analysts with the maintenance of minutes, IRB rosters, IRB hard copy and electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and IRB SOPs.
- Screens submissions that do not require convened board review, including review of submissions for completeness and adherence to institutional policies, regulatory and ethical criteria for approval, as well as preparation of clear and concise stipulations to investigators.
- Handles submissions qualifying for exempt and limited review (initials and modifications).
- Handles submissions qualifying for expedited review (i.e. modifications, exceptions, deviations, reportable events, etc.).
- Works closely with investigators during the screening process and provides consultation to the research community on submission requirements, advice on preparation of IRB applications and associated documents for submission to the IRB.
- Supports projects aimed to improve delivery and quality of IRB service and work with the Senior Team as needed for current and ongoing projects within the department.
- Trains Administrative Assistant or Coordinator Staff as needed.
Benefits
- Excellent healthcare benefits
- Tuition benefits for employees and their families
- Generous retirement benefits
- Wide variety of professional development opportunities
- Supportive work and family benefits
- Wealth of health and wellness programs and resources
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Flexible spending accounts for eligible health care and dependent care expenses with pre-tax dollars
- Tuition assistance for employees, spouses, and dependent children at Penn and other institutions
- Generous retirement plans (Basic, Matching, and Supplemental) with pre-tax or Roth basis options and a wide variety of investment options through TIAA and Vanguard
- Substantial amount of time away from work
- Long-Term Care Insurance
- Wellness and Work-life Resources
- Professional and Personal Development resources
- Access to a wide range of University resources as well as cultural and recreational activities
- Discounts and Special Services (arts and entertainment, transportation, mortgages, new cars, cellular phone service plans, movie tickets, theme parks)
- Flexible Work Hours
- Penn Home Ownership Services (forgivable loan for eligible employees)
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
