Clinical Trials Regulatory Specialist I (ETS) | Temporary
Emory University · Atlanta, Georgia, US
Discover Your Career at Emory University Emory University is a leading research university that fosters excellence and attracts world-class talent to innovat...
Job description
Discover Your Career at Emory University Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. Description: The Clinical Trials Regulatory Specialist I is an entry-level position supporting regulatory affairs in clinical trial research. The primary focus of the position is to collaborate with the multiple IRBs, sponsoring companies, and site Project Managers to ensure study documents receive committee approval and are made available to the site in a timely manner. This position will oversee pre-submission to governing agencies, and provide foundational information for more complex regulatory work. Incumbents in this job classification may be primarily focused on non-interventional studies, with a relatively small trial portfolio. KEY RESPONSIBILITIES: - Assists regulatory team (Regulatory Specialist II and III) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving h...