Piper Clinical Solutions is seeking a motivated Clinical Research Quality Assurance Specialist in Bethesda, MD to support an established research firm supporting both commercial and government clients with ongoing clinical research trials. The QA Specialist will be responsible for QA Training, Audits, and CAPA Investigations related to assigned clinical research studies.
Responsibilities for the Clinical Research Quality Assurance Specialist:
· Ensure assigned clinical trial projects meet client and federal regulatory compliance requirements
· Support and maintain upkeep of Quality Management System and train site research staff on proper procedures, compliance and regulatory requirements
· Maintain the QA training program, document control and Corrective Action Preventative Action (CAPA) program
· Obtain and develop metrics to identify areas of improvement and potential CAPA investigations
· Lead all CAPA investigations and develop reports based on findings for all assigned studies
· Review and maintain QA plans and lead process improvement initiatives
· Prepare, analyze, and update Project Specific Standard Operating Procedures (SOP) for assigned studies
· Manage and support clinical sites, suppliers, and vendors to ensure quality assurance compliance
· Conduct external audits of clinical sites including document management and quality management systems to ensure compliance and identify areas for process improvement
· Verify site compliance utilizing SOPs and other applicable regulations (GCP, GDP, GXP)
· Lead and support internal audits of trial documentation/SOPs and ensure compliance with Good Clinical Practice (GCP) standards and client protocols
Requirements for the Clinical Research Quality Assurance Specialist:
· 2+ years of Quality Assurance experience working within a clinical research organization and supporting clinical trials (GCP/GDP/GXP)
· Advanced knowledge of medical terminology
· Certified Quality Auditor (CQA) certification preferred
· Bachelors required in science-related field, Master’s Degree preferred
Compensation for the Clinical Research Quality Assurance Specialist:
· Salary range: $60,000 – $90,000 based on meeting of qualifications
· Benefits: Health, Dental, & Vision insurance and 401K
Please send all qualified resumes to: bnoell@pipercompanies.com
Keywords:
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30727
Clinical & Life Sciences
Bethesda, MD 20817
None
Piper Companies
Piper Clinical Solutions