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Quality Assurance Consultant

1 month ago


Nashville, United States System One Holdings, LLC Full time

Title: Quality Assurance Consultant Location: 100% remote Duration: 1 year contract, possible contract to hire Compensation: $30-36/hr. Start Date: ASAP Joule is currently looking for a Clinical Research Quality Assurance Consultant.You will primarily responsible for providing guidance and support to Company Development Innovations or functional groups supported by Corporate Quality, as appropriate, and the Quality Management Systems (QMS) processes to meet GCP and regulatory requirements in the conduct of clinical trials. You will also manage Sponsor audits, assists in hosting regulatory inspections, and conducts internal, site and vendor audits as assigned. Duties and Responsibilities: •Develop and maintain effective relationships with Sponsors, Company operational leaders, operational colleagues supporting research activities and all other colleagues, as necessary •Provide guidance to research operations on the interpretation of ICH-GCP, local and federal regulatory requirements as related to the conduct of clinical research •Prioritize and escalate "Critical" and "Major" quality issues, identified procedural gaps and/or other areas of deficiency. Report deficiencies to Executive and Physician leadership, where appropriate •Manage and facilitate all external Sponsor, IRB, or other audits of Innovations, including but not limited to preparation, hosting, responding and follow-up of those deliverables resulting from the sponsor's audits •Manage and facilitate any regulatory agency inspection of Innovations, including but not limited to preparation, hosting, triaging, responding and continued follow-up of those deliverables resulting from theregulatory inspection •Provide guidance and support for non-conformance resolution including root-cause analysis, corrective and preventive actions Required: Bachelor's degree preferred, relevant experience may be substituted for education 3+ years of relevant experience Must have strong understanding of a quality management system that meets ISO 9001 Must have strong understanding of ICH E6 R3 Must have a strong understanding of KPIs, KQIs, how to collect and analyze these Preferred: Certified Clinical Research Professional, ASQ Certified Quality Auditor, ISO 9001 Certified Lead Auditor, or Certified Medical Device Auditor


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