Regulatory Operations Specialist

The Research Regulatory Specialist is responsible for coordinating the daily activities associated with supporting the regulatory department at the Nancy N. and J.C. Lewis Cancer & Research Pavilion (LCRP). The individual will perform clerical activities including filing, scanning, faxing and documentation management.

The individual will be responsible for the upkeep of regulatory documentation associated with pharmaceutical and National Cancer Center (NCI) Central Institutional Review Board (CIRB) and the ADVARRA CIRB as appropriate. The individual will be responsible for safety reporting, updating the LCRP and Georgia Center for Oncology Research and Education (GA CORE) websites, regulatory meeting minutes, bi-weekly research meeting minutes and assisting the manager and regulatory coordinator with additional research related duties.

Ensures that all regulatory documents are in compliance and maintained in accordance with Good Clinical Practice (GCP), Department of Health and Human Services (DHHS), and the Food and Drug Administration (FDA) guidelines.

Works independently to assure compliance with the requests of sponsors, SJ/C IRB and internal managers as needed. Works with Regulatory and Compliance Manager, the Research Regulatory Coordinator
- Lead and the Clinical Research Coordinator (CRC) in scheduling and conducting monitoring visits, responding to monitoring, audit reports and additional research protocol duties as needed.

Maintains sponsor, investigator and research personnel regulatory communication.

Associate's Degree is required, Bachelor's Degree is preferred.

1-2 Years of General Healthcare or Legal experience is preferred.

Good Clinical Practice (GCP) and Human Protections Training is preferred.

• Assist in maintaining regulatory master files for each clinical trial and assist in preparing documents for IRB and/or sponsor review.
• Ensure all study specific Financial Disclosure Forms (FDFs), annual FDFs and safety reports are prepared, filed, completed, and submitted accurately in a timely manner.
• Maintain research staff trainings and credentialing using a tracking system.
• Coordinate various forms of communication, including but not limited to telephone, email and responding to the Regulatory & Compliance Manager and Regulatory Coordinator.
• Maintain historical and current documents for clinical trials utilizing both CREDIT & Florence software and others as appropriate.