"Clinical Research Regulatory Affairs Specialist"

Job Description Summary

Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.

Job 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.

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.

This position is contingent upon grant funding.