Emory University · 6 hours ago
Clinical Trials Regulatory Specialist II- Division of Infectious Diseases, Hope Clinic
Atlanta, GA
Full-time
Onsite
Entry, Mid Level
2+ years expEmory University is a leading research university that fosters excellence and attracts world-class talent. The Regulatory Specialist II at the Hope Clinic will support regulatory affairs in clinical trial research, coordinating submissions and ensuring compliance with regulations throughout the trial process.
E-LearningEducationHealth Care
Responsibilities
Supports clinical research team (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects
Documents any exceptions to compliance standards
Manages new submissions, amendments, safety reports, and continuing review activities
Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports, deviations, and review of safety reports
Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations
Serves as primary contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical)
Provides direction and feedback to research team to ensure awareness of business practices and quality standards
Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities
Attends research team meetings to report on regulatory issues
Responsible for administrative duties corresponding to budgets and contracts
Performs related responsibilities as required
Qualification
Required
Bachelor's degree and two 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
Company
Emory University
Emory University is an institute of higher learning and a private research university.
10001+ employees
H1B Sponsorship
Emory University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (417)
2024 (370)
2023 (308)
2022 (266)
2021 (164)
2020 (162)
Funding
Current Stage
Late StageTotal Funding
$719.87MKey Investors
GettyNational Institutes of HealthHyundai Hope On Wheels
2025-08-20Grant· $0.28M
2024-11-13Grant· $15M
2024-08-28Grant· $0.4M
Leadership Team
Claire E Sterk
President Emerita and Charles Howard Candler Professor of Public Health
Gregory Fenves
Chancellor
Recent News
2026-01-16
News-Medical.Net
2025-11-23
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