Summary

The Senior Quality Assurance (QA) Associate will monitor clinical research study activities for the Texas Children's Cancer and Hematology Centers (TXCH) and the BCM Center for Cell and Gene Therapy (CAGT) to ensure compliance with all relevant local, federal, and state regulatory and institutional policies while identifying protocol problems, reviewing study-related documents, and ensuring that appropriate corrections are made and documented for missing or incomplete data. Under the guidance and supervision of the Lead QA/QC, the Senior QA Associate will perform quality assurance audits of TXCH and CAGT clinical trials. Additionally the Senior QA Associate will serve as the back-up committee administrator for the TXCH Data Review Committee (DRC) and the TXCH and CAGT Protocol Review Committees (PRC).

Job Duties

• Performs quality assurance evaluations (audits) of clinical trials for TXCH/CAGT. The QA audit includes evaluation of regulatory process as well as specific patient data. This includes review primarily of investigator-initiated treatment studies, however may also include group or industry sponsored studies and non-treatment studies administered by TXCH and CAGT.
• Runs the audits from beginning to end. This includes setting up the audit, notifying appropriate personnel of the pending audit, conducting and coordinating the audit, and reporting the results back to the stakeholders including the IND holder (if applicable), the PI, the study staff and the Clinical Research Oversight Committee.
• Ensures procedures meet or exceed all relevant institutional, state, and federal requirements for the conduct of clinical research; and ensures clinical research activities are conducted, generated, documented, and reported in compliance with the protocol, Good Clinical Practice (GCP) guidelines, and all other applicable regulatory agencies.
• Modifies clinical research standard operating procedures (SOPs) as dictated by changes to the regulations and implements improvements as necessary.
• Prepares QA audit reports for principal investigators (PIs) and clinical research teams to effectively communicate findings, and works with TXCH and CAGT leadership to provide suitable recommendations for corrective actions.
• Presents QA audit reports to the TXCH/CAGT Clinical Research Oversight Committee (CROC) at monthly meetings.
• Serves as the back-up committee administrator for the TXCH DRC and the TXCH and CAGT PRCs. This includes covering all committee administrator duties in the absence of the committee administrator, coordinating the meetings, overseeing distribution of appropriate materials to the committee members, preparing minutes from the meeting, and distributing these minutes to the committee members and investigators in a timely manner.

Minimum Qualifications

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

Preferred Qualifications

• CCRA, CCRP, or CCRC certification
• Knowledge of clinical research operations, medical terminology, and anatomy
• Prior oncology clinical research QA/QC experience