Emory University Clinical Trials Regulatory Specialist in atlanta, Georgia
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. 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.
MINIMUM QUALIFICATIONS: 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.
--80385BR, 76520BR and 77814BR
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Job Number 15367
Job Type Regular Full-Time
Division Exec.V.P. for Health Affairs
Department Winship Clinical Trials
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