Clinical Quality Assurance Specialist - NIH
Company: Kelly
Location: Rockville
Posted on: May 9, 2022
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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.
Keywords: Kelly, Rockville , Clinical Quality Assurance Specialist - NIH, Healthcare , Rockville, Maryland
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