Regulatory Affairs Specialist
Greenville Health System - Greenville, SC

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Under minimal supervision, coordinates the research and administrative activities of clinical trials for the practice by managing Regulatory and Quality Assurance procedures. Responsible for regulatory and safety support services including trial communication and document distribution, critical document collection process, safety reporting, translation of informed consent documents and communication with sponsor representatives. Provides this support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines.

Job Qualifications:
Post high school education of one (1) year to 18 months in a clinical or scientific related discipline AND two (2) years of clinical research and/or regulatory affairs required. A minimum of one year oncology experience preferred. Must have basic computer skills and computer proficency in Microsoft Word, Excel and Powerpoint.

A Bachelor's Degree in a clinical or scientific related discipline and Clinical Research certification preferred.

Greenville Health System - 20 months ago - save job - - block
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