Quality Assurance Coordinator, Ophthalmology Clinical Research

UT Southwestern Medical CenterDallas, TX
Onsite

About The Position

The Quality Assurance Coordinator will be based within the Department of Ophthalmology Clinical Research Unit (CRU) and will work collaboratively under the supervision of CRU Management to support the quality, regulatory, operational, and administrative functions of the Clinical Research Unit. This position is responsible for coordinating quality assurance and regulatory activities to ensure compliance with institutional, sponsor, federal, and Good Clinical Practice (GCP) requirements while supporting the efficient conduct of clinical research operations. Responsibilities include performing Regulatory responsibilities, quality and compliance oversight, data analysis and reporting, process improvement initiatives, audit coordination, and staff education. The position also supports CRU operations, including but not limited to clinical trial billing compliance, finance-related activities, grants and contracts administration, budgeting support, documentation review, work queue management, operational reporting, and special projects as assigned. Working closely with investigators, research personnel, institutional offices, sponsors, and support departments, the Quality Assurance Coordinator contributes to maintaining regulatory compliance, operational efficiency, data integrity, and high-quality clinical research operations.

Requirements

  • Associate's Degree in related field
  • 3 years of experience
  • An equivalent combination of education and experience may be considered in lieu of the required degree.

Nice To Haves

  • Bachelor's Degree
  • Experience working in a healthcare facility

Responsibilities

  • Coordinating quality assurance and regulatory activities to ensure compliance with institutional, sponsor, federal, and Good Clinical Practice (GCP) requirements.
  • Supporting the efficient conduct of clinical research operations.
  • Performing Regulatory responsibilities.
  • Quality and compliance oversight.
  • Data analysis and reporting.
  • Process improvement initiatives.
  • Audit coordination.
  • Staff education.
  • Supporting CRU operations, including clinical trial billing compliance, finance-related activities, grants and contracts administration, budgeting support, documentation review, work queue management, operational reporting, and special projects.
  • Maintaining regulatory compliance, operational efficiency, data integrity, and high-quality clinical research operations.

Benefits

  • PPO medical plan, available day one at no cost for full-time employee-only coverage
  • 100% coverage for preventive healthcare-no copay
  • Paid Time Off, available day one
  • Retirement Programs through the Teacher Retirement System of Texas (TRS)
  • Paid Parental Leave Benefit
  • Wellness programs
  • Tuition Reimbursement
  • Public Service Loan Forgiveness (PSLF) Qualified Employer
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