Regulatory Affairs Start-Up Specialist Senior-CC

University of Pennsylvania•New Orleans, LA

12d•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 is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Position contingent upon funding. The ACC Regulatory Affairs Office seeks a full-time Senior Regulatory Affairs Start-Up Specialist to independently prepare and process the regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the Senior Regulatory Affairs Start-Up Specialist will independently prepare and process all initial oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees. In collaboration with the Regulatory Administrative Coordinator, he/she will 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 Senior Regulatory Affairs Start-Up Specialist is expected to independently resolve regulatory queries, and participate in the initiation of the new study, as well as communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation. He/she will participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings. The Senior Regulatory Affairs Start-Up Specialist is expected to oversee the development of investigator-initiated research protocols, the development and submission of FDA IND applications, and the development of study specific forms and source document tools, as well as, to provide direct regulatory/compliance guidance and oversight of investigator-initiated trials and investigator-initiated multi-site trials.

Requirements

Bachelor’s degree preferably in a life science or human subject protection field and 5-7 years of related experience or equivalent combination of education and experience required.
Minimum 4 years regulatory start-up experience required; at least 2 years' experience in the clinical setting (pharmacy, patient care) with interactions across legal, finance, and clinical workflows required.
Experience conducting high risk biomedical research required; specific knowledge of oncology interventional research required; previous experience with protocol development and design preferred; previous experience developing and implementing CAPAs required.
The successful candidate must have 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; advanced knowledge of IRB and human research protection regulations, including ICH GCP guidelines.
The successful candidate must be self-driven with heightened attention to detail.
Candidates must desire to work in a fast-paced environment with competing priorities.
Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth.
Candidates must have a 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, BlueJeans etc.

Nice To Haves

Advanced degree preferred.
Research credential (CCRP, CIP, etc.) preferred; required within 2 years of hire.
Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products, etc. is a plus.

Responsibilities

Independently prepare and process the regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation.
Independently prepare and process all initial oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees.
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.
Independently resolve regulatory queries, and participate in the initiation of the new study, as well as communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation.
Participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings.
Oversee the development of investigator-initiated research protocols, the development and submission of FDA IND applications, and the development of study specific forms and source document tools, as well as, to provide direct regulatory/compliance guidance and oversight of investigator-initiated trials and investigator-initiated multi-site trials.

Benefits

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.
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.
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.
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.
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.
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.
Penn provides an array of resources to help you advance yourself personally and professionally.
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.
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 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 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.
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.