Quality and Regulatory Specialist I - Hybrid

Quality and Regulatory Specialist is responsible for ensuring compliance with quality standards, federal regulations, industry guidelines and company procedures. Maintain knowledge of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), ISO 17025:2017, Standard Operating Procedures (SOP), and Federal and applicable regulations.Performs review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documentsReview company policies and procedures to ensure they meet regulatory standardsCollaborate with operational teams to ensure regulatory compliance is considered during the design process and scope of deliveryPreparing and submitting documentation to regulatory agencies and accrediting bodies, as neededKeeping up-to-date with changes in regulatory legislation, guidelines, and industry standardsMonitoring and setting standards for quality controlInvestigating and setting standards for safety and healthAssessing outcome, compliance, or operational risks and developing risk management strategiesConducting internal audits to measure and assure adherence to established QA standards in accordance with applicable regulations and guidelinesTraining staff and team members about quality, regulatory, and compliance issuesMaintaining and organizing necessary documentationAddressing non-compliance issuesWorks directly with international coordinators and project managers to ensure accurate documentation is performed for clientsConducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH complianceAssists with auditing the company training filesAssist with documentation of root-cause analysis stemming from internal non-conformances, corrective actions, and preventive actionsAssist in the review of clinical study protocol deviationsTraining of new departmental staffOther duties or tasks assigned by manager or supervisorEncourage prompt reporting of health and safety concerns.