Senior Clinical Research Quality Assurance Associate

Summary

The Senior Quality Assurance (QA) Associate performs QA evaluations (audits) of clinical trials for the Texas Children's Cancer and Hematology Centers (TXCH) and the Baylor College of Medicine Center for Cell and Gene Therapy (CAGT) to ensure patient safety, verify accurate data collection, identify problem areas, and work with appropriate individuals to implement corrective action as necessary. The QA evaluation includes evaluation of both regulatory processes as well as specific patient data. Additionally the Senior Quality Assurance 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).

The QA Program has been established based on guidance from the Food and Drug Administration (FDA). The Senior Quality Assurance Associate must ensure that the program continues to meet or exceed expectations as determined in collaboration with the FDA. Included in meeting these expectations is a need to project audit goals, plan audit activities to meet those goals and on an annual basis assess compliance with meeting those goals. Additionally, the Senior Quality Assurance Associate should recommend necessary improvements/changes to the program as dictated by changes to the regulations or the regulatory environment. Any changes/modifications to the QA program must be codified in the QA SOP and QA Plan both of which require review/approval prior to implementation of any changes.

Job Duties

• Under the supervision of the Director, Clinical Research QA/QC, the Senior Quality Assurance Associate is responsible for assisting with all facets of the Quality Assurance Program including improvement of the program, implementation of any improvements to the program and general oversight of the program.
• Plan study specific audit deadlines, develop action plans for delinquent or inadequate audit responses and manage audits from beginning to end. This includes setting up the audits, notifying appropriate personnel of the pending audits, 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 Operations Committee.
• Serve 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

• B.S. or B.A. in science or health related field required
• Master's Degree in health related field and CCRA, CCRP, or CCRC certification
• At least 4 years experience in clinical research
• Knowledge of clinical research operations, medical terminology, and anatomy; oncology knowledge and prior clinical research QA/QC experience

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

6838

CA; CH