Title:  Clinical Research Quality Assurance and Control Associate

Summary

The Quality Assurance and Control Associate (QA/QC Associate) will monitor clinical research study activities for the Texas Children's Cancer and Hematology Centers (TXCH) and Baylor's 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 QA/QC Associate will provide training and quality control (QC) evaluations for TXCH and CAGT clinical research staff. The QA/QC Associate will also coordinate review and approval of TXCH/CAGT clinical research Standard Operating Procedures (SOPs).

Job Duties

• 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, treatment and non-treatment studies administered by TXCH and CAGT.
• Coordinates the SOP training for all new clinical research staff, which includes preparing new hire-specific competency checklists, scheduling training sessions, participating in SOP training, and following up with the new hires on completion of their checklists.
• Assists with the review and approval of new SOPs and modifications to existing SOPs.
• Provides support for clinical research operations by assisting in the preparation for audits by entities such as the FDA, industry sponsors, or cooperative groups, and entering enrollments on pediatric cancer-related studies into OnCore on a monthly basis.
• Prepares QC review 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 QC review reports to the TXCH/CAGT Clinical Research Oversight Committee (CROC) at monthly meetings.

Minimum Qualifications

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

Preferred Qualifications

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