Emory University Senior Clinical Trials Regulatory Specialist in Decatur, Georgia
Supports clinical research team (physician-investigators, clinical research staff, nurses, etc.) in research efforts by facilitating the protocol approval process and overseeing documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
Establishes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations and guidelines.
Reviews processes involving regulatory documentation to assure appropriate timelines are followed.
Researches and analyzes problems and takes a leadership role in resolving.
Identifies and manages issues and provides feedback to leadership regarding resolution.
Disseminates information and coordinates or conducts training.
Reviews documentation of exceptions to compliance standards to assure information is accurate and complete.
Participates in the development and implementation of standard operating procedures, development and revision of regulatory orientation plans, and orientation and mentorship of newly hired staff.
Actively participates in designated committees within the unit and Emory University.
Performs related responsibilities as required.
Bachelor's degree and three 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.
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Job Number 31212
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 Laboratory
Emory University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all applicable Federal and Georgia State laws, regulations, and executive orders regarding nondiscrimination and affirmative action in its programs and activities. Emory University does not discriminate on the basis of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Inquiries about this statement should be directed to the Office of Equity and Inclusion, 201 Dowman Drive, Administration Bldg, Atlanta, GA 30322