• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Clinical Quality Assurance Specialist

Job Number: 34955


Job Description

As a Clinical Quality Assurance Specialist, you will ensure GCP compliance, manage clinical vendor selection, oversee SOPs, and lead TMF assessments. You will also prepare for BiMO audits and maintain robust data management processes.


  • Ensure GCP and ICH compliance throughout clinical development.
  • Develop and manage GCP training programs for stakeholders.
  • Select and qualify clinical trial vendors.
  • Develop and maintain clinical SOPs.
  • Conduct on-site audits for vendors and sites.
  • Perform regular TMF assessments for accuracy.
  • Develop a quality management system for BiMO audit readiness.
  • Analyze audit findings and develop CAPAs for GCP deviations.
  • Stay updated on GCP regulations and best practices.
  • Document activities and maintain training records.

Required Skills

  • Bachelor's in science or related graduate degree.
  • CCRP or equivalent certification required.
  • 3+ years (Master's) or 5+ years (Bachelor's) in clinical quality assurance.
  • Knowledge of FDA, GCP, and ICH requirements.
  • Experience in vendor management and clinical SOP development.
  • Expertise in TMF management and BiMO audits.
  • Strong analytical and problem-solving skills.
  • Excellent communication and organizational skills.
  • Proficient in enterprise platforms (EDC, PLM, CRM).
  • Innovative and hands-on approach.
  • Team player, highly organized, and detail-oriented.
  • 10% – 25% travel required.


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