Clinical Research Regulatory Specialist C (Abramson Cancer Center)

Description

Job Responsibilities

The ACC seeks a full-time NCI / NCTN Senior Regulatory Affairs Study Start-Up Specialist to participate in the coordination of Phase I-III clinical trials sponsored by the NCI / NCTN.

Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the NCI / NCTN Senior Regulatory Affairs Study Start-Up Specialist will prepare and process, independently all initial oversight submissions regulatory documentation through the Penn IRB / CIRB, CTSRMC, and all applicable regulatory review committees.

In collaboration with the Regulatory Affairs Administrative Coordinator, he / she will prepare and process all required regulatory documentation for the NCI, the FDA, and certain federal grants, as well as, organize and maintain all regulatory affairs documentation / files as required;

including study startup timelines. The NCI / NCTN Senior Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal supervision, 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 across departments within the Abramson Cancer Cetner and Perelman School of Medicine and regional sites within the NCTN @ Penn network.

Qualifications

• 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;

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 Microsoft Teams, Zoom, WebEx, etc.

Knowledge and / or experience working with web-based e-regulatory document management systems such as CTSU, IRBManager, Veeva Systems products, etc. is a plus.

Bachelor’s degree (preferably in a life science or human subject protection field) required and 5-7 years research experience required;

at least 4 years regulatory experience preferred. Experience conducting high risk biomedical research and / or oncology regulatory research experience preferred.

Associated research credentialing (CCRP, CIP, etc.) preferred. Associated research credentialing (CCRP, CIP, etc.) preferred;

required within 2 years of hire.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$61,046.00 - $85,907.00 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.