Regulatory Research Specialist
About the Employer
Clinical Research Regulatory Specialist B
Job Title
The Penn Neurogenetics Therapy Center (PNTC) supports a diverse group of neurogenetics investigators and clinical research professionals conducting investigator-initiated clinical research and complex, industry-sponsored, first-in-human trials of gene therapies for neurological diseases.
Job Profile Title
Clinical Research Regulatory Specialist B
Job Description Summary
The PNTC is seeking a Clinical Research Regulatory Specialist B (CRRS-B) to support clinical trial startup and ongoing regulatory activities across the center's portfolio of clinical trials while following applicable institutional and federal regulations as well as ICH-GCP guidelines.
Job Description
The CRSS-B will play a key role in coordinating trial start-up activities from feasibility assessment through site activation, working closely with PNTC project and business managers, investigators, study teams, institutional offices, sponsors, and contract research organizations (CROS).
Responsibilities include:
Coordinate clinical trial startup from feasibility assessment through site activation, working collaboratively with PNTC project and business managers and other stakeholders to track regulatory and ancillary submissions, essential study documentation, timelines, dependencies, outstanding items, and activation requirements across regulatory, operational, budget, and contract workflows.
Prepare, coordinate, and process regulatory submissions to the IRB and required ancillary review committees, and prepare, collect, and submit essential regulatory documentation required by sponsors, CROS, and other applicable entities.
Provide ongoing regulatory support for active clinical trials, including protocol amendments, continuing reviews, reportable events, personnel and study document updates, and other required regulatory submissions and documentation.
Maintain complete, accurate, current, and inspection-ready regulatory documentation and investigator site files (ISFs) throughout the study lifecycle in accordance with institutional, sponsor, and applicable regulatory requirements.
Resolve regulatory queries and support study oversight activities, including site initiation, monitoring, audit, inspection, and close-out activities, in collaboration with investigators and study teams.
Participate in study team meetings, protocol and regulatory training, and compliance activities, and contribute to the development and continuous improvement of regulatory and clinical trial startup processes, guidance documents, templates, trackers, and other work tools.
Perform additional duties as assigned.
Qualifications
Required Qualifications
Bachelor's degree and 3-5 years of research experience or equivalent combination of education and experience is required. At least 1 year of regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.Preferred Qualifications
Must be organized and able to prioritize; Effective communication and writing skills; Strong time management skills; Flexible and able to multi-task; Demonstrated ability to work as part of a team, as well as independently. At least 1 year of regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$63,085.00 - $70,119.00 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, and in Alignment with Salary Ranges Based on External Market Data for the Job's Level.
Internal Organization and Peer Data at Penn Are Also Considered.
Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.
Special Requirements
Background checks may be 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 healthcare 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 Anenberg 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.