Clinical Trials Regulatory Specialist III

Role Overview

• The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research.
• Support all trial complexities (basic to multiphase) and manage the study activation process.
• Liaison between the sponsor, the investigator, Winship, Emory IRBs, external IRBs and internal departments/staff.
• Prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
• Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
• Establish and maintain processes and monitors practices to ensure regulatory documentation complies with Institutional Review Board (IRB) policies and procedures and regulations.
• Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
• Disseminate information and coordinate or conduct training.
• Perform internal audit and quality assurance checks on regulatory documents.
• Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees.

Requirements

• Bachelor's degree and five years of experience in a research environment, or an equivalent combination of experience, education and training.
• Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
• Must obtain all required training courses within one month of hiring date.
• Must possess an applicable research certification within 2 years of hire (i.e. ACRP, SOCRA, RAC etc.).

Benefits

• not applicable