Clinical Research Regulatory Specialist C (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

Clinical Research Regulatory Specialist C (Abramson Cancer Center)





Job Profile Title

Clinical Research Regulatory Specialist C





Job Description Summary

Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn),regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Clinical Research Regulatory Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.


Clinical Research Regulatory Specialist C will lead the coordination of unit/department clinical research, including but not limited to Phase I-IV clinical trials. The Clinical Research Regulatory Specialist C will, independently prepare and process all regulatory documentation/applications through the IRB and requisite ancillary review committees. Regulatory applications may include new study submissions, continuing reviews, amendments, adverse events, and reportable events. The Clinical Research Regulatory Specialist C will, independently prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), and required governmental agencies, as well as, organize and maintain all regulatory affairs documentation/investigator site files (ISF) as required. The Clinical Research Regulatory Specialist C is expected to resolve regulatory and data queries as required, and lead the conduct of initiation, monitoring, audit and close-out visits related to the conduct of the research at the site. The Clinical Research Regulatory Specialist C will lead study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Clinical Research Regulatory Specialist C is expected to lead the development of unit guidance/process documents including work tools, and development/maintenance of study specific case report forms, as well as, to provide direct regulatory/compliance guidance. The Clinical Research Regulatory Specialist C will serve as a mentor and/or trainer to more junior members of the regulatory research team/study team. Additional duties relevant to regulatory affairs as assigned.





Job Description


Job Responsibilities

+ Lead the coordination of unit clinical research, including but not limited to Phase I-IV clinical trials.

+ Independently prepare and process all regulatory documentation/applications through the IRB and requisite ancillary review committees. Regulatory applications may include new study submissions, continuing reviews, amendments, adverse events, and reportable events.

+ Independently prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), and required governmental agencies, as well as, organize and maintain all regulatory affairs documentation/investigator site files (ISF) as required.

+ Resolve regulatory and data queries as required, and lead the conduct of initiation, monitoring, audit and close-out visits related to the conduct of the research at the site.

+ Lead study team meetings, research team meetings, and ongoing protocol training/compliance meetings.

+ Lead the development of unit guidance/process documents including work tools, and development/maintenance of study specific case report forms, as well as, to provide direct regulatory/compliance guidance.

+ Serve as a mentor and/or trainer to more junior members of the regulatory research team/study team.

+ Perform additional regulatory duties as assigned.






Qualifications

+ Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required. At least 2 years of regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) preferred (or to be completed within 1 year of employment).








Job Location - City, State

Philadelphia, Pennsylvania





Department / School

Perelman School of Medicine





Pay Range

$61,046.00 - $77,920.00 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.