Summary
The Manager, Quality Assurance and Control (QA/QC Manager) will manage QA/QC 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. The QA/QC Manager will provide training and quality control (QC) evaluations for TXCH and CAGT clinical research staff, and will perform quality assurance (QA) audits of TXCH and CAGT clinical trials. The QA/QC Manager will review and update existing clinical research Standard Operating Procedures (SOPs) as well as develop new SOPs as needed, and provide associated training to the TXCH/CAGT clinical research staff.
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.
Job Duties
- Sets study specific QA audit goals, plans audit activities, and performs a yearly assessment of compliance with meeting those goals.
- Monitors protocol compliance and documentation, performs clinical study conduct reviews, and verifies clinical research staff competencies. This includes review of investigator-initiated, group sponsored, industry sponsored, multi-site, treatment and non-treatment studies administered by TXCH and CAGT.
- Prepares QA audit and QC review reports for principal investigators (PIs) and clinical research teams to effectively communicate findings, and works with senior TXCH and CAGT leadership to provide suitable recommendations for corrective actions.
- Presents QA audit and QC review reports along with annual assessments of QA/QC activity to the TXCH/CAGT Clinical Research Oversight Committee (CROC) at monthly meetings.
- Presides over QA audits and QC reviews, and assists study staff in preparing for outside audit/monitoring visits and collection of delinquent data.
- Performs training and evaluation of TXCH/CAGT clinical research staff (research nurses, research coordinators, data managers, and regulatory coordinators) with regard to adherence to relevant clinical research operations and SOPs.
- Manages primarily professional level junior and senior QA/QC staff, to include defining work responsibilities and prioritization, setting performance development plans and goals, and conducting annual performance evaluations.
- Performs other job related duties as assigned.
Minimum Qualifications
- Bachelor's degree.
- Four years of relevant experience.
Department Specific Criteria
- Knowledge of clinical research operations, medical terminology, and anatomy required
Preferred Qualifications
- B.S. or B.A. in science or health related field
- CCRA, CCRP, or CCRC
- Prior oncology clinical research QA/QC experience
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.