Clinical Quality Specialist

Clinical Quality Specialist Responsibilities:• Support Clinical study team on the development of Quality Control Plans and perform implementation of quality control activities for assigned projects according to agree upon timelines • Conduct Quality Control activities which include, but are not limited to the following: o Support Quality reviews of clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations. o As applicable, review quality of Study Reports and Publications to confirm that the study was performed in accordance with the agreed upon protocol, regulatory requirements and that the clinical study is accurately and completely reported o Review of Trial Master File to ensure accuracy and completeness of the documentation. o Perform and/or support the implementation of integrated and comprehensive data-driven QC activities to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness. o Support Clinical R&D preparation, conduct and response to internal and external audits. o Prepare periodic quality control reports for assigned clinical projects, identify areas of risk and review, and communicate trends with Clinical Trial Core teams. o Using available systems tools (e.g., EDC, CTMS and eTMF generated dashboards and reports), support compilation of monthly project performance metrics for department by organizing, analyzing, preparing presentation, and facilitating Clinical Management Review (CMR) meeting. o Identify problems through analysis of project performance metrics and, with support of Quality Systems Leader, recommend corrective and preventive action (CAPA) based on knowledge of applicable regulations; ensure completion of CAPAs generated through internal and external audits. o Support Clinical R&D CAPA resolution by taking ownership, when applicable, on the corrective and preventative actions; track and ensure timely resolution of all Clinical R&D CAPAs. o Actively engage and collaborate with Clinical Trial Managers/Leaders and other members of the Clinical R&D, as applicable, to resolve any identified issues/problems. o May visit sites with Monitors to improve site performance as necessary. o Participate in/support FDA BIMO audit preparation and execution. • Responsible for tracking training/updating curriculums for all Clinical R&D associates, working with the relevant associates across the campus sites to ensure compliance with all training requirements. • May be involved in other tasks to support Clinical R&D, as needed. • Participate in Clinical Trial/Study Core Team meetings, as required. • Provide internal communication of important clinical data and event. • Establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders. • Participate in departmental initiatives across the Clinical R&D aimed at improving process and efficiency, for the improvement of local processes• Support Quality Systems Leader in ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance. • Participate in project management meetings and provide an overview of clinical quality and workload as needed.Experience and Education:• Minimum Bachelors/University degree with 4-6 years of experience or equivalent required. Master's with 3 years or PhD/MD/PharmD with 1 years of relevant experience preferred • Relevant industry certifications preferred (i.e., CCRA, RAC, CDE) • Requires understanding and application of GCP regulations and standards applied in clinical areas and MedTech/combination products • Clinical/medical background - desired • Requires at least 1 year of Clinical Quality Control/Assurance experience (MedTech and pharma - desired, CRO monitoring experience - desired) Required Knowledge, Skills:• Knowledge and understanding of GCP (including ICH-GCP), applicable FDA regulations, EU Directive, and ISO 14155 • Understanding of quality control application in clinical research • Knowledge and understanding of the processes involved in conducting a clinical trial • Excellent interpersonal, communication and presentation skills • Change Management

Created: 2025-02-19