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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Employers By State in 2021.
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.
COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements, visit the Penn COVID-19 Response website for the latest information.
Posted Job Title
Regulatory Affairs Specialist (Hybrid Eligible) (Department of Radiation Oncology)
Job Profile Title
Regulatory Affairs Specialist
Job Description Summary
Regulatory Affairs Specialist-The UPENN Coordinating Center for the RadComp trial, a national multi-site randomized clinical trial (www. Radcomp.org) seeks an experienced regulatory coordinator to manage and execute the regulatory and compliance activities across 30 enrolling sites. This position will report to the RadOnc CTO Associate Director of Compliance and Quality Assurance and the RadComp Coordinating Center Project Manager. Responsibilities include day-to-day quality assurance oversight in alignment with Good Clinical Practice (GCP) to ensure inspection readiness and compliance with the requirements of the University of Pennsylvania, the Abramson Cancer Center, and all applicable regulatory bodies. The candidate must have a thorough knowledge of ICH-GCP regulations and comprehensive understanding of clinical trial processes, and the conduct of clinical research studies. (Hybrid Eligible)
Job Description
The Regulatory Affairs Specialist will execute a comprehensive regulatory compliance program for this national, multi-site study:
With guidance from the RadOnc CTO Associate Director of Compliance and Quality Assurance, function as the Sponsor regulatory compliance coordinator charged with overseeing and conducting regulatory compliance activities at both the coordinating center and participating site levels.
Engage with enrolling sites to maintain, refine, and develop, as needed, regulatory compliance standard procedures and workflows for maximum effectiveness and efficiency.
With direction from the RadOnc CTO Associate Director of Compliance and Quality Assurance, develop and execute a multi-site regulatory compliance plan and provide regulatory expertise and training to the Sponsor and site teams.
Assist all RadComp sites in preparation and maintenance of audit-ready regulatory binders and files, including working to prepare for audits, perform internal or advance pre-audits and other QA activities, and support monitor/audit visits by the Abramson Cancer Center Department of Compliance and Monitoring
Assist with regular in-service training for enrolling site research staff regarding regulatory compliance. Assist enrolling site Principal Investigators in implementing corrective action plans for study-specific deviations, data compliance and regulatory process concerns.
Prepare, submit and track modifications of protocol and study documents to applicable regulatory bodies for relying and non-relying sites.
Maintain site contact and system access database.
Qualifications:
A minimum of a Bachelor's degree and 3-5 years' experience in health administration or related field or an equivalent combination of education and experience required.
Training and experience in clinical research compliance or clinical research auditing
Thorough knowledge of Good Clinical Practices (GCP), and relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines
Prior experience in developing policy or procedural documentation and/or standard operating procedures
Excellent verbal/written communication skills; excellent technical writing, review, and analytical abilities
Excellent interpersonal and customer service skills; ability to work collaboratively on all levels and to gain support of others
Detail oriented with excellent organizational and multitasking skills required; able to work under pressure and exercise mature judgment, be resourceful and take initiative.
Ability to exercise discretion in working with highly confidential and sensitive matter;
Strong MS Office skills
Position in contingent upon grant funding.
Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week that is divided between working onsite and working remotely.
Job Location - City, State
Philadelphia, Pennsylvania
Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 - $78,096.00
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
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.
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 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.
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.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay