Clinical Research Site Quality Assurance Specialist

5 days ago


New Haven, Connecticut, United States Katalyst HealthCares & Life Sciences Full time
Quality Assurance Specialist for Clinical Trials

Katalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of clinical research sites in adherence to relevant regulations and standards.

Key Responsibilities:
  • Conduct and oversee quality activities to build out clinical research sites in accordance with Good Clinical Practice, FDA, and sponsor requirements.
  • Ensure that clinical equipment is handled, supplies are inventoried and stored appropriately to meet regulatory needs.
  • Develop and implement quality policies, procedures, and protocols to ensure compliance with regulatory requirements.
  • Support scheduling for installation, calibration, and qualification of clinical equipment.
  • Quality oversight and authorship of quality-related documents, including policies, procedures, and reports.

Requirements:

  • Strong understanding of Good Clinical Practice, FDA, and sponsor regulations.
  • Excellent communication and project management skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.


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