Summary

The Senior Quality Assurance and Control Associate (Senior QA/QC 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 QA/QC Manager, the Senior QA/QC Associate will provide training and quality control (QC) evaluations for TXCH and CAGT clinical research staff. The Senior QA/QC Associate will also review and update existing clinical research Standard Operating Procedures (SOPs) as well as develop new SOPs as needed.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certificationareeligible for certification pay.

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.
• Provides SOP training for TXCH and CAGT clinical research staff.
• Develops, distributes, and maintains clinical research standard operating procedures based on regulations and implements improvements as necessary.
• 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.
• Provides support for clinical research operations by assisting in the preparation for audits by entities such as the FDA, industry sponsors, or cooperative groups.
• 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.
• Performs other job-related duties as assigned.
  

Minimum Qualifications

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

Preferred Qualifications

• B.S. or B.A. in science or health related field
• CCRA, CCRP, or CCRC
• Knowledge of clinical research operations, medical terminology, and anatomy
• Prior oncology clinical research QA/QC experience