Clinical Research Regulatory Specialist C

University of Pennsylvania Perelman School of Medicine • Philadelphia, PA

16h • $75,804 - $85,907 • Onsite

About The Position

Leads 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.

Requirements

• 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.

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.

Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
• Flexible spending accounts for health care and dependent care expenses
• Tuition assistance for employees, spouses, and dependent children
• Generous retirement plans (Basic, Matching, and Supplemental)
• Substantial amount of time away from work
• Long-Term Care Insurance
• Wellness programs and resources
• Professional and Personal Development resources
• Access to a wide range of University resources, cultural and recreational activities
• Discounts on arts and entertainment, transportation, and mortgages
• Flexible work options
• Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
• Adoption Assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level