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Clinical Quality Assurance Specialist

1 month ago

Reston, Virginia, United States Bayside Solutions Full time

Clinical Quality Assurance Role

W2 Contract Opportunity

Job Summary:

We are seeking a skilled Clinical Quality Assurance professional to provide compliance support for sponsored clinical trials. The ideal candidate will have extensive knowledge of ICH GCP, regulatory requirements, and industry standards.

Key Responsibilities:

  • Collaborate with clinical functions to ensure GCP compliance.
  • Participate in clinical study execution teams to enable risk-based quality management.
  • Perform quality reviews of clinical trial documents.
  • Support GCP audits, inspections, and vendor management.
  • Assess and coordinate activities related to quality issues.
  • Escalate identified issues to QA Management as needed.

Requirements and Qualifications:

  • Bachelor's degree in a scientific or technical discipline.
  • 12+ years of experience in GCP Quality with a focus on audit management, inspection readiness, and quality management system responsibilities.
  • Extensive knowledge of ICH GCP, regulatory requirements, and industry standards.
  • Effective communication and relationship-building skills.
  • Ability to critically evaluate and troubleshoot complex problems.
  • Proficiency with Microsoft Office and other computerized systems.

Desired Skills and Experience:

Clinical Quality Assurance, GCP, FDA, EU, ICH, regulatory inspection, audit management, drug development, Microsoft Office.

Bayside Solutions, Inc. is a leading provider of clinical quality assurance services. We are committed to delivering high-quality solutions that meet the needs of our clients.