What are the responsibilities and job description for the Clinical Quality Specialist position at Kelly Science, Engineering, Technology & Telecom?
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.
Experience and Education :
Required Knowledge, Skills :
