Quality Assurance and Control Associate - Clinical Research

The Research Quality Analyst will assist with development, implementation, and management of the quality assurance program for the Clinical Trials Support Unit within the Dan L Duncan Cancer Center. The primary purpose of the quality assurance program is to ensure patient safety, verify accurate data collection, identify problem areas, and work with appropriate individuals to implement corrective action as necessary. This role is eligible for a hybrid work schedule.

• Assists in the maintenance of standard operating procedures.
• Maintains the QA/QC program including but not limited to: project audit goals, plan audit activities, notify appropriate personnel of the audits, conducting and coordinating the audits, and reporting the results back to the stakeholders, the PI, the study staff and the Clinical Research Leadership Committee.
• Maintains accurate and complete documentation of work performed.
• Conducts procedures in compliance with all relevant guidelines in accordance with the Food and Drug Administration (FDA) guidance, Good Clinical Practice (GCP) and applicable NCI’s National Clinical Trials Network (NTCN) guidance.
• Serves as back-up support for the Patient Safety Officer’s DRC/DSMB, PRMC and CRLC committee duties. This includes coordinating meetings, overseeing distribution of appropriate materials to the committee members, preparing minutes from the meeting, and distributing these minutes to the committee members in a timely manner.

• Bachelor's degree.
• Two years of relevant experience.

• Prior clinical research experience is a plus.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

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