Clinical Quality Assurance Specialist - NIH

Company: Kelly
Location: Rockville
Posted on: May 9, 2022

Job Description:

TASKS/SERVICES
(1) Support the development, implementation, maintenance, and oversite of a clinical quality management system in NIAID.
(2) Facilitate working groups to collaborate and write project-controlled documents as part of the quality management system: SOPs, policies, audit reports, etc.
(3) Support the development and implementation of the Division's electronic Clinical Quality Management System (MasterControl).
(4) Stay current with changes to current GCP/GCLP regulations, including FDA, EU, and other regulatory bodies and guidance bodies.
(5) Lead internal and external audits of the various quality elements to ensure compliance with GCP/GCLP, industry best practices and guidance.
(6) Participate in oversight and management of Investigator Site Audits, Internal Audits, and Clinical Vendors/CROs Quality Programs with guidance from management.
(7) Support the development and/or review of GCP/GCLP audit agendas, audit plans, audit reports, and CAPAs for internal & external audits.
(8) Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.
(9) Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; provide assessment of the impact of any deficiencies.
(10) Review, track, report, and/or observe trends in routine quality data and other QA metrics
(11) Report adverse trends to management with remediation plan.

REQUIREMENTS
(1) Bachelor's degree in a related discipline.
(2) Minimum of five (5) years of experience in clinical research including quality assurance and quality management
(3) Experience establishing and managing quality management systems for clinical research (e.g. in pharmaceutical companies, biotechnology companies, CRO, or government sponsors).
(4) Working knowledge of the quality management cycle (i.e., Plan-Do-Check-Act (PDCA)) and corrective Action/Prevention Action (CAPA) processes.
(5) Experience with US and international Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) regulations, guidance documents, and industry best practice in all areas of a GxP environment.
(6) Knowledge of electronic clinical quality management systems (such as Veeva, MasterControl, etc.) highly preferred.
(7) Experience building and maintaining relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs), troubleshooting issues, identifying root causes, and systematically resolving problems
(8) Experience with regulatory inspections from the US FDA or similar government regulatory authorities preferred.
(9) Experience conducting or overseeing audits, working at a clinical research site, and/or experience with federal agencies are preferred.

Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

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