Clinical Quality Assurance Specialist - Job ID:4075

Description:
 

  • Clinical Quality Assurance Specialist will assist with Clinical QA and Compliance workload
  • Plans, coordinates and conducts internal audits and provides oversight for external audits GCP-related audits (domestic and international) .
  • Assists with the development and implementation of detailed audit plans and schedules in support of Clinical QA objectives.
  • Review and approval of audit observations and CAPAs
  • Assist in the development of the Quality Management System, from the GCP perspective.  This includes writing, reviewing, and updating Standard Operating Procedures (SOPs) and any other associated documentation.


Requirements:

 

  • BS with 5+  years experience planning, executing and resolving Investigator Site Audits; System / Process Audits; Vendor audits (CROs, Labs), Data Audits; Trial Master File Audits; Document Audits (protocol, ICF,IB, CSR)
  • **This is an in house role!



Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com


Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
www.cwsciences.com

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