Clinical Research Regulatory Specialist B
University of Pennsylvania•Philadelphia, PA
•Onsite
About The Position
Coordinates regulatory activities for clinical trials with minimal supervision, including preparation and submission of documentation to IRBs, ancillary committees, sponsors, CROs, and regulatory agencies. Organizes and maintains investigator site files, resolves regulatory queries, and participates in monitoring, audit, and close-out visits. Contributes to the development of unit guidance documents and case report forms, and provides direct regulatory and compliance support to study teams.
Requirements
- 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.
Nice To Haves
- Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.
Responsibilities
- Participate in the coordination of unit/division clinical research, including but not limited to Phase I-IV clinical trials.
- Prepare and process all regulatory documentation/applications through the IRB and requisite ancillary review committees.
- 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 participate in initiation, monitoring, audit and close-out visits related to the conduct of the research at the site.
- Participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings.
- Facilitate the development 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.
- Perform additional regulatory duties as assigned.
Benefits
- excellent healthcare
- tuition benefits for employees and their families
- generous retirement benefits
- a wide variety of professional development opportunities
- supportive work and family benefits
- a wealth of health and wellness programs and resources
- comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- flexible spending accounts
- tuition assistance here at Penn
- tuition assistance at other institutions for dependent children
- generous retirement plans
- pre-tax or Roth basis retirement savings
- wide variety of investment options through TIAA and Vanguard
- substantial amount of time away from work
- long-term care insurance
- wellness and work-life resources
- professional and personal development resources
- access to a wide range of University resources as well as cultural and recreational activities
- free admission and memberships to Penn arts and cultural centers and museums
- great deals for University faculty and staff on goods and services
- flexible work options
- forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
- adoption assistance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
