Regulatory Operations Specialist

Regulatory Operations Specialist

Position Summary

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 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. The successful candidate complies with all SJ / C policies, procedures, departmental guidelines, and applicable laws in the conduct of routine activities and the solution of problems; prepares documents for regulatory review, monitoring and auditing.

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.

Education

Associate's Degree b- Required

Bachelor's Degree - Preferred

Experience

1-2 Years of General Healthcare of Legal experience - Preferred

License & Certification

Good Clinical Practice (GCP) and Human Protections Training - Preferred

Core Job Functions

• 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. Other trial-related documents are processed in a timely manner. Responsible for delivery and pickup of regulatory documents between site locations and retrieving provider and staff signatures.
• 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. Accurately managing documents in accordance with appropriate clinical trial. Responsible for ordering supplies and scheduling the conference room for the office.
• Maintain historical and current documents for clinical trials utilizing both CREDIT & Florence software and others as appropriate. Maintain the LCRP website and GA CORE website to ensure all active trials are visible to the community. Ensure appropriate research sites are activated within the CREDIT system.

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