Associate Director, Education and Quality Assurance (Abramson Cancer Center) - University of Pennsylvania

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 Large Employers in 2023.




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

Associate Director, Education and Quality Assurance (Abramson Cancer Center)





Job Profile Title

Associate Director, Clinical Research Quality





Job Description Summary

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific cancer programs within the ACC. Reporting to the Director of Clinical Research Operations for the ACC CRU, the Associate Director of Education and Quality Assurance will be responsible for the overall education and training program for the ACC CRU Clinical Research Professionals (CRPs) and investigators to support the conduct of cancer clinical trials, and is responsible for the day to day quality assurance oversight that is aligned with ICH Good Clinical Practice (GCP) to ensure ACC CRU inspection readiness comply with the requirements of the University of Pennsylvania, FDA, 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.





Job Description


Job Responsibilities


The candidate will direct the planning, design, preparation and delivery of comprehensive clinical research training and development programs for ACC CRU CRPs and investigators. The candidate is responsible for evaluating and enhancing CRP and investigator learning, continuing education, development, and growth.



+ Direct comprehensive orientation and training programs for ACC CRU CRPs including program managers, clinical research nurses, clinical research nurse practitioners, clinical research coordinators, biospecimen coordinators, and research assistants. Direct oversight of a training needs analysis to determine specific training needs for CRPs. With the assistance of the CRU Education and Training Program Manager, the candidate will train new CRPs to independently to conduct Phase I – IV complex clinical trials, including consenting, screening and enrolling subjects after ensuring eligibility, managing subjects’ treatment per protocol, collecting and reporting research data, serious adverse event reporting per protocol and institutional requirements, and ensuring adherence to protocol requirements. The candidate will develop tools and assessments to ensure effective training of new hires and reduce time to proficiency and create and maintain a system to document CRP training to ensure comprehensiveness and quality of training.


+ Direct ongoing training, continuing education, development and growth for CRU CRPs and investigators. Identify, select, and/or develop appropriate training programs, including the selection or design of appropriate training aids


+ Lead in-service training for ACC CRU CRPs and communicate ongoing training opportunities and continuing education training programs available within the University of Pennsylvania and in the Research Community to further advance these initiatives.


+ Directly manage and supervise the ACC CRU Education and Training Program Manager, including performance management and overseeing the hiring process when needed. Assess the need for additional CRPs for Education and Training and develop plans for hiring additional CRPs as needed in conjunction with the ACC CRU Director of Clinical Research Operations and the CRU Medical Director.



The candidate will develop and maintain an internal quality assurance and improvement program for the CRU to enhance the conduct of CRU clinical trials to ensure adherence to all University of Pennsylvania, FDA and GCP guidelines. In conjunction with ACC Regulatory, the candidate will direct the preparation, and daily workflow for ACC CRU external inspections by the FDA, EMA, and NCTN/Cooperative Groups.



+ Develop a program to continually assess protocol compliance and data quality across the CRU research teams and prepare reports for the ACC CRU Director of Clinical Research Operations and the Lead Physician Investigator for each research team.


+ Develop process improvements and guidance documents to ensure adherence to standard operating procedures, GCP, and requirements of all applicable regulatory bodies, increase unit efficiency, and reduce errors.


+ Conduct regular internal reviews of CRU trials including review of institutional internal audits (i.e. ACC and OCR) to identify problems with protocol compliance, patient safety, and data integrity. Report findings to study PI, Lead Physician Investigator for the Research Team, ACC CRU Medical Director and ACC CRU Director of Clinical Research Operations. Review and content editing recommendations for all internal & external audit responses.


+ Create ACC CRU-wide corrective actions and develop training related to research compliance, quality control and quality assurance. Assist Principal Investigators and Research Team Program Managers/ Lead Clinical Research Nurses in developing corrective action plans for study-specific deviations.


+ Develop a program to assist research teams with improving data integrity and documentation. Assess the need for additional CRPs for Quality Improvement and develop plans for hiring additional CRPs as needed in conjunction with the ACC CRU Director of Clinical Research Operations and the ACC CRU Medical Director.


+ Collaborate with the ACC CRU AD of Clinical Research Operations, the ACC CRU Director of Clinical Research Operations and the ACC CRU Medical Director with unit-wide guidance documents and work instructions to enhance processes.


+ Interview candidates, check references and make hiring recommendations to the ACC CRU Research Teams as requested.





Qualifications

+ Master of Science, Master of Arts, and 5 to 7 years of experience or equivalent combination of education and experience is required. Training and experience in clinical research or clinical research compliance healthcare required. At least 5 years’ experience in a hospital, academic medical setting, or pharmaceutical industry with principal responsibilities related to clinical research and or research education preferred. Oncology experience preferred.



+ An in-depth knowledge and experience in the application of the relevant regulations for the conduct of clinical research including International Conference of Harmonization (ICH) Good Clinical Practice (GCP) and FDA Title 21 Code of Federal Regulations (CFR) requirements. Knowledge of IRB and human research protection regulations. Ability to interpret regulations and disseminate information is desired.


+ Supervisory experience and/or managing teams preferred.


+ Able to confidently interact with all levels of management including senior management, physician leaders and other collaborators.


+ Demonstrated ability to work collaboratively on all levels and to gain support of others.


+ Experience developing and implementing policy or procedural documentation and training tools preferred.


+ Experience with FDA/federal agency inspections preferred.


+ Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems is preferred.


+ Must be detail oriented and organized. Strong planning, time management, and organizational skills along with attention to detail, excellent follow-through, and problem-solving skills necessary.


+ Excellent interpersonal communication and writing skills required. Strong MS Office skills.


+ Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously.


+ Excellent technical writing, review, and strong analytical abilities.







Job Location - City, State

Philadelphia, Pennsylvania





Department / School

Perelman School of Medicine





Pay Range

$106,400.00 - $130,000.00 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, 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.




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



The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on 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.