Job Details

The Research Quality and Regulatory Specialist will support the department by ensuring adherence to regulatory standards, procedural compliance, and the maintenance of quality systems within the Research department. in accordance with local and Federal regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans. Job Specific Duties and Responsibilities: Seeks current information and maintains current knowledge base to analyze and interpret applicable regulations (federal and local laws, guidance, ICH-GCP, Revised Common Rule, 46 CFR 46, standards for accreditation, etc.)Assists with the development of new SOPs and reviews and provides revisions of current research SOPs as needed. Conducts regular audits to identify potential deviations from study protocol or regulatory documents in compliance with local, state, and federal regulations. Prepares quality management reports (QA metrics) and analyzes trends to identify process failures and ...Regulatory, Research, Clinical Research, Specialist, Quality, Quality Assurance, Technology, Healthcare