Emory Healthcare/Emory University Clinical Trials Regulatory Specialist I in Atlanta, Georgia
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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 diversity and excellence of our academic community.
The Clinical Trials Regulatory Specialist supports the 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.
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.
Manages identified issues and provides feedback to leadership regarding resolution.
Disseminates information and participates in training.
Provides direction and feedback to research team to ensure awareness of business practices and quality standards.
Documents any exceptions to compliance standards.
Manages new submissions and continuing review activities.
Reviews initial submissions to determine review category and action to be taken.
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.
Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.
Attends research team meetings to report on regulatory issues.
Responsible for administrative duties corresponding to budgets and contracts.
Performs related responsibilities as required.
Bachelor's degree and two years of experience in a research environment, or an equivalent combination of experience, education and training. Knowledge of clinical research practices.
Must complete all required training courses within one month of hiring date.
NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
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Job Number 77780
Job Type Regular Full-Time
Division School Of Medicine
Department SOM: Medicine: Infectious Dis
This position may involve the following Health and Safety issues: Not Applicable
Job Category Research & Research Administration
Location : Name Grady
Campus Location (For Posting) : Location US-GA-Atlanta
Emory Healthcare/Emory University
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