Clinical Research Regulatory Specialist B

Job Description Summary

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.

Job Description

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.

CONTINGENT UPON FUNDING

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.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$62,000.00 - $68,500.00 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.