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Aso Dir, Accreditation
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Medical Office Asst Gi Center
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Registrar Services Coordinator I
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Accountant Iii
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Code Officer
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Practice Supervisor, Plastic
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Environmental Health and Safety Specialist
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Library Assistant
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Library Specialist
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General Manager
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Coordinator, Early Learning Research
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Site Environmental, Health, and Safety Lead
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Quality Officer
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Investigation Specialist Ii
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Conference-event Planner Iii
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Business Office Manager
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Patient Financial Counselor
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Compliance Officers - Gainesville, GA, United States - Northeast Georgia Health System, Inc
Description
Research & Research AdministrationWork Shift/Schedule:
8 Hr Morning - Afternoon
Northeast Georgia Health System is rooted in a foundation of improving the health of our communities.
The Research Regulatory Specialist performs a wide range of tasks essential to the submission, approval, and maintenance of required regulatory documents for conducting clinical research in compliance with the Federal Food and Drug Administration (FDA).
This position assures that all requirements are met for internal and external oversight bodies including, but not limited to, OHRP, DHHS, the Food and Drug Administration (FDA), the National Cancer Institute (NCI), Cooperative Groups, pharmaceutical & industry sponsors, IRB of Record and/or Central IRB (if applicable), and NGMC Research Committees.
Education and/or experience in a healthcare related field and one (1) year experience in clinical research and regulatory procedures is strongly desired.
Preferred Experience:
Specialized training/certification in Regulatory Affairs or Clinical Research.
Must possess excellent written/editorial, interpersonal, verbal communications and computer literacy skills
proofread documents, research information; manage projects use computer systems; use team-building skills
Foster and promote a positive departmental image by ensuring regulatory documents are accessible and organized
Knowledge of Microsoft Office, EMR and CTMS systems preferred
General knowledge of medical terminology preferred
Completes in a timely manner, the submission of all documents to the IRB required for the initial application of new studies and the annual renewal of current studies.
Such documents include, but not limited to, FDA Form 1572, Financial Disclosures, Protocol Signature Page, Investigational Brochure and other documents required.
Develops, implements, and evaluates data and time management processes to meet compliance guidelines and data submission deadlines for regulatory bodies and protocol sponsors.
Accurate and timely compliance with protocol and regulatory requirements.Communicates routinely to the research staff about protocol updates and regulatory changes by updating the CTMS or by other appropriate methods.
Reviews research studies offered by appropriate sources to help determine if studies are consistent with the department's goals / objectives and patient population.
Actively participates in the development, implementation, monitoring, and regulatory oversight of high quality research within the department. Familiarity with clinical trials operations, finance, budgets, contracting and billing. Knowledge of Medicare, Medicaid, and/or commercial payer guidelines. Assumes an active role during an audit to assure compliance with the regulatory component of the audit.Communicates new informational updates on clinical trials to investigators and staff in a timely and complete manner by updating the CTMS or by other appropriate methods.
Routinely identifies methods that facilitate investigator compliance.Maintains information for Adverse Event and External Safety Reports for submission to the IRB, protocol sponsor, in compliance with the FDA and IRB policies.
training certification, CVs, etc.) according to established department policies, procedures, and sponsor requirements. Participates in the development, review, and maintenance of clinical research policies and standard operating procedures (SOPS).Job Requires:
Reading, Writing, Reasoning, Talking, Keyboarding, Driving
Working at NGHS means being part of something special: a team invested in you as a person, an employee, and in helping you reach your goals.
Northeast Georgia Health System is an Equal Opportunity Employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, protected veteran status, genetic information, or any other legally protected classification or status.
