Regulatory Affairs Specialist-CC

University of Pennsylvania•New Orleans, LA

12d•$62,000 - $70,119•Remote

About The Position

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 One Cancer Clinical Research (OCCR) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Specialist-CC to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. He/she will, with minimal supervision, prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as well as organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Specialist-CC is expected to resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits. He/she will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist-CC is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site trials. Additional duties relevant to regulatory affairs as assigned.

Requirements

Effective problem solving and critical thinking abilities
Effective communication and writing skills
Strong organizational and time management skills
Flexible and able to multi-task
Demonstrated ability to work as part of a team, as well as independently
Knowledge of IRB and human research protection regulations, including ICH GCP guidelines
Self-driven with heightened attention to detail
Desire to work in a fast-paced environment with competing priorities
Welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth
High level of general computing ability
Intermediate/expert level of function in all of the Microsoft Office applications, as well as applications for team interconnectivity such as Slack, Microsoft Teams, Zoom, WebEx, etc.
Bachelor’s degree (preferably in a life science or human subject protection field) required
3-5 years research experience or equivalent combination of education and experience is required
At least 1 year's regulatory experience preferred

Nice To Haves

Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products, etc. is a plus.
Experience conducting high risk biomedical research and/or oncology regulatory research experience preferred.
Associated research credentialing (CCRP, CIP, etc.) preferred.

Responsibilities

Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as well as organize and maintain all regulatory affairs documentation/files as required.
Resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits.
Participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings.
Facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site trials.
Additional duties relevant to regulatory affairs as assigned.

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.