Job Description
Responsibilities:
Assists co-workers and internal customers with interpretation of regulatory requirements (e.g., GLP/GCP), SOP requirements, and other guidance documents, as applicable.Reviews data to ensure quality standards are met and to verify compliance with applicable SOP and regulatory requirements.Maintains working knowledge of client SOPs and requirements as applicable. Ensures that data reviewed meets applicable client SOPs and requirements.Performs regularly scheduled audits of departmental systems and supporting data, as applicable, to ensure proper documentation and maintenance (e.g. training files, client SOP reading lists, logbooks, etc.). Collect error tracking data for items reviewed and reports trends as feedback to the department.Monitors citation trends and performs follow-up actions with respondents, management, or others, if needed, to prevent recurring citations, problems, or errors.
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