Regulatory Affairs Assistant

Regulatory Affairs Assistant

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.

Responsibilities:

• General understanding of GCP/ICH guidelines
• Assist with collecting and preparing regulatory documents for submission to sponsor and IRB.
• Assist with maintaining current regulatory-related documents to include CVs, licenses, and required training documents.
• Assist with set-up of electronic Investigator Site File for all awarded studies.
• Collect signatures on regulatory documents as required.
• Assist with maintaining current study logs such as Screening and Enrollment Logs, Training Logs
• Assist with filing study-related correspondence (sponsor, IRB, etc.) in the Investigator Site File.
• Assist with resolution to regulatory items identified during monitoring visits.
• Maintain current training with applicable SOPs/WIs, GCP, etc.
• Assist with archiving of study documents following study closure.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.

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 are required.