IRB Analyst I

IRB Analyst I

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.

Job Responsibilities

• The IRB Analyst I works as a floater, supporting other IRB Administrators / Analysts with administrative activities of the University's 8 committees. This includes: screening submissions assigned to the convened IRB for completeness; attending convened meetings of the IRB and maintaining thorough and complete notes on the discussion 1-2 times per month; preparing 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. Preparing written correspondence to investigators of all IRB actions and decisions. Working with researchers and research staff to resolve issues related to convened IRB or expedited IRB review; preparing the meeting agenda, as needed; assigning scientifically appropriate protocols to IRB members to review, as needed; conducting IRB member trainings, as needed; supporting 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.
• The IRB Analyst I screens submissions that do not require convened board review. Screening includes the 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. Submission types include: submissions qualifying for exempt and limited review (initials and modifications); 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.
• Training of Administrative Assistant or Coordinator Staff as needed.

Qualifications

• Bachelor's and 2 to 3 years of experience or equivalent combination of education and experience is required
• 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

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Provost's Center

Pay Range

$65,628.00 - $75,000.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with familywhatever your personal needs may be.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitementand you and your family can enjoy many of these activities for free.
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.