Hybrid Clinical Trials Regulatory Specialist III

at Emory University

• Job title: Clinical Trials Regulatory Specialist III
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: No Education Requirement
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Atlanta, United States

About the role

• Regulatory Specialist III supporting clinical trials and managing regulatory affairs and compliance at Emory University. Liaison between sponsors, investigators, and regulatory entities.

Responsibilities

• 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.
• Serve as the internal project manager for assigned specific oncology disease group(s).
• Liaison between the sponsor, the investigator, Winship, Emory IRBs, external IRBs and internal departments/staff.
• Independently 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.
• Responsible for 35+ trial load per year of NCTN, industry and investigator-initiated trials.
• Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
• Coordinate protocol activation/maintenance process and communicate to allow for enrollment to start.
• Disseminate information and coordinate or conduct training.

Requirements

• Typically requires a Master's degree and several years of experience in clinical research, with a focus on regulatory affairs.
• Strong knowledge of federal regulations, IRB processes, and relevant guidelines (e.g., ICH/GCP) is essential.
• Excellent verbal and written communication skills are required for interacting with various stakeholders.
• A high level of accuracy and attention to detail is critical for managing complex documentation.
• Must be highly organized and able to manage a large workload, often involving multiple trials.
• Strong computer skills, including experience with clinical trial management systems and standard office software, are necessary.
• Bachelor's degree and five years of experience in a research environment, or an equivalent combination of experience, education and training.
• 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

• Health and Safety Information
• Remote Work Classification Hybrid