Regulatory Affairs Assistant

Job Description

The Regulatory Affairs Assistant supports efforts to ensure regulatory submission targets are met. Completes all duties under the direction of the Regulatory Manager or Site Director. In executing these position responsibilities, the Regulatory Coordinator is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.

• Administrative:
  • Auxiliary with collecting and preparing regulatory documents for submission to sponsor and IRB.
  • Auxiliary with maintaining current regulatory-related documents to include CVs, licenses, and required training documents.
  • Auxiliary with set-up of electronic Investigator Site File for all awarded studies.
  • Auxiliary with collecting signatures on regulatory documents as required.
  • Auxiliary with maintaining current study logs such as Screening and Enrollment Logs, Training Logs.
  • Auxiliary with filing study-related correspondence (sponsor, IRB, etc.) in the Investigator Site File.
  • Auxiliary with resolving to regulatory items identified during monitoring visits.
  • Auxiliary with maintaining current training with applicable SOPs/WIs, GCP, etc.
  • Auxiliary with archiving of study documents following study closure.

Skills and Qualifications

• Education and experience:
  • High School Diploma or its equivalent; Two-year degree preferred.
  • Clinical Research experience preferred but not required.
• Requirements:
  • Working knowledge of medical terminology and the clinical research process.
  • Attention to detail.
  • Organizational Skills.
  • Strong computer skills, including knowledge of all components of Microsoft Office.