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The Clinical Research Group is part of the Research Center for Neglected Diseases of Poverty, located at the George Washington University School of Medicine and Health Sciences. This position will support the Clinical Research Group (CRG) within the SMHS Departments of Medicine and Microbiology, Immunology & Tropical Medicine in the implementation and maintenance of the group s clinical and laboratory quality management systems.
This experienced position performs research of the CRG and also handles many outreach, operational, and administrative functions of the research center, to include data collection, annotation, report generation, and relationship-building. This research position often handles administrative duties operationally, in addition to providing strategic input for the research center. This role performs duties in support of the administration and ongoing support of the CRG, including logistics, documentation oversight, and collaborating on data quality procedures. The position typically collaborates on evaluating research methods, procedures, and techniques based on established objectives. Performs a variety of Quality Assurance activities that ensure compliance with FDA, ICH and GxP guidelines and regulatory requirements. This includes:
- Manages the day-to-day quality operations via oversight of all elements of the CRG s Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, data integrity, and training- Manages all aspects of group s training system including maintenance of training records, oversight of training compliance, and periodic auditing of training records.- Collaborates to identify quality issue root cause and track CAPA investigations; work with clinic and/or lab staff to bring investigations to completion.- Provide direct operational support for internal/external GxP audits, and support regulatory inspections, as needed.- Prepare Standard Operating Procedures for existing and or developing programs/facilities.- Serve as the Quality administrator for lot release of Necator americanus hookworm larvae for use in clinical trials, performing review of manufacturing records and quality control data.- In coordination with other operational groups (e.g., MITM Clinical Immunology Lab, MITM Parasitology Lab, GW MFA), support initiatives that contribute to a continual state of inspection readiness for clinical trial programs.- Contribute to FDA regulatory submissions, annual reports, and clinical study reports.
Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Qualified candidates will hold a BA/BS in a related discipline plus 5 years of relevant professional experience. Degree must be conferred by the start date of the position.
- Experience in clinical research or laboratory, supporting GxP processes and systems is preferred.- Knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials.- Ideal candidate will have broad experience in basic clinical and/or laboratory operations, compliance principles in GCP, GLP and/or GMP, strong attention to detail and solid organizational skills.
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