IRB Associate Director, Compliance & QA

Job description



IRB Associate Director, Compliance & QA

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title
IRB Associate Director, Compliance & QA

Job Profile Title
Associate Director D

Job Description Summary
Reporting to the Director of Human Research Protections, the Associate Director of the IRB assists the Director of Human Research Protections in ensuring compliance with all federal and state statutes and regulations on protection of human subjects. The Associate Director will also supervise IRB staff and lead staff training. He/ She will represent IRB through attendance on local committees and IRB meetings, support the maintenance of AAHRPP accreditation, and conduct initial investigations of non-compliance.

Job Description

  • Provides support for IRB operations by managing convened board assignments; assists with designating expedited assignments to staff as needed
  • Serve as voting member of 2 IRB Committees; Responsible for overseeing ongoing relationships with IRB members of those boards; Identifies and communicates needs for new IRB members
  • Signature authority for IRB related actions
  • Initiate new job requisitions in Workday; Leads interview and hiring process
  • Leads staff training initiatives and onboarding; Serve as a staff resource and provides constructive feedback to maximize quality of review; Assists on educational initiatives on an as needed basis
  • Directly supervise administrators/analysts, establishing priorities and deadlines. Assists with performance evaluation completion.
  • Assists with the development and revision of policies and procedures to ensure compliance with all applicable regulations, policies, and guidance
  • Assists with federal oversight communications and interactions as needed; Acting authority in the absence of the Director
  • Manages the IRB Executive Committee (IRB 9)
  • Supports maintenance of AAHRPP Accreditation
  • Conducts initial investigation of non-compliance, provides support for management of non-compliance and CAPAs; Assists with special projects and other QI initiatives, as needed
  • HRAC Administrator; Liaison to Penn Medicine OCR Compliance Team; Oversees the review of OCR Audit Reports
  • Assists with managing subject complaints as needed


Qualifications

A Bachelor's Degree and 7 years to 10 years of experience, or equivalent combination of education and experience is required. Experience and knowledge directly related to IRB issues and human subjects research protection or equivalent combination of experience and education; (typical experience might include ethics, clinical trial performance, and/or experience in an academic health center or medical school IRB); detailed knowledge of applicable federal regulations related to IRB and clinical research; experience with compliance aspects of regulatory review and oversight highly desirable.

University Benefits:

Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect your 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 family—whatever 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 excitement—and 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.

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

Demonstrated management skills and/or experience; must be able to work independently with minimal supervision; proven writing skills; excellent oral communications skills; excellent customer service skills.

Certification as an IRB professional (CIP) is highly desirable and will be required within 24 months of hiring if not certified.

COVER LETTER IS REQUIRED FOR CONSIDERATION

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Provost's Center

Pay Range
$59,703.00 - $113,435.00

Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

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


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/3600-Civic-Center-Boulevard---9th-Floor/IRB-Associate-Director--Compliance---QA_JR00029063





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Job No:
Posted: 2/19/2021
Application Due: 2/19/2033
Work Type: Full Time
Salary: