Clinical Research Regulatory Specialist CLeads regulatory operations for clinical research, independently managing submissions to IRBs, committees, sponsors, CROs, and regulatory agencies. Oversees regulatory documentation, resolves complex compliance issues, and directs initiation, monitoring, audit, and close-out visits. Guides development of regulatory tools and processes, provides expert regulatory and compliance guidance, and mentors junior staff in regulatory practices and study oversight.
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.
Assist with the purchasing and requisition of supplies needed to conduct and operate clinical trials.
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).Position is contingent upon continued funding.
Job Location: City, State
Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range$75,804.00 - $85,907.00 Annual RateSalary 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 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.
