Quality Assurance and Control Associate
The Quality Assurance Associate will support the clinical research quality assurance (QA) program for both the Texas Children’s Cancer and Hematology Centers (TXCH) and the Center for Cell and Gene Therapy (CAGT). 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. The QA evaluation will include evaluation of both the regulatory processes as well as specific patient data. Additionally the Quality Assurance Associate will be the administrator for the Data Review Committee/Data Safety Monitoring Boards (DRC/DSMBs) and the Protocol Review Committees (PRCs) for TXCH and CAGT.
The QA Program has been established based on guidance from the Food and Drug Administration (FDA). The 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.
The position will be integrated within the larger Center for Cell and Gene Therapy which is a highly collaborative translational research center affiliated with Texas Children’s Hospital, Baylor College of Medicine and Houston Methodist Hospital.
- 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.
- Plan study specific audit deadlines, develop action plans for
delinquent or inadequate audit responses and in general help to
oversee the QA Program. This includes setting up the audits,
notifying appropriate personnel of the pending audits, conducting
and coordinating the audits, 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.
- Serve as the administrator for the DRC/DSMBs and PRCs for TXCH
and CAGT. This includes 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
- Bachelor's degree.
- Two years of relevant experience.
- B.S. or B.A. in science or health related field
- CCRA, CCRP, or CCRC certification
- At least three years experience in clinical research knowledge of medical terminology and anatomy; oncology knowledge and prior clinical research QA experience
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.