The Senior Quality Control Associate will provide training and quality control (QC) evaluations for clinical research staff of the Texas Children's Cancer and Hematology Centers (TXCH) and the Baylor College of Medicine Center for Cell and Gene Therapy (CAGT). The Senior Quality Control Associate also coordinates review, approval, and associated training on Protocol Office Standard Operating Procedures (SOPs).Job Duties
- The primary purpose of the training, the SOPs and the QC program is to ensure patient safety, verify accurate data collection, identify problem areas, and work with appropriate individuals to implement corrective action as necessary for all clinical research activities at TXCH/CAGT. The training program includes general training in clinical research, job specific training, and team/disease-specific training (which should be determined and developed in collaboration with the team leaders).
- The QC evaluations include evaluation of specific patient/protocol data to determine accuracy as well as evaluating compliance of the clinical research operations staff to the relevant TXCH/CAGT Clinical Research SOPs. Results of the QC evaluations are reported back to the Clinical Research Oversight Committee (CROC) and to the team leaders (as appropriate).
- Serves as a mentor and facilitator for the DM/RN/RC staff within TXCH/CAGT. As new initiatives are implemented within the DM/RN/RC group, the Senior Quality Control Associate will serve as the point person for the initiative. They will serve as the liaison between the DM/RN/RC staff and the team/group implementing change.
- Provides support for clinical research operations by assisting in the preparation for audits by entities such as the FDA or by cooperative groups.
- Workflow is completed on a self-assigned, independent basis with responsibility to follow through to completion and meet deadlines as required. Direct communication with the team leaders, the Clinical Research Oversight Committee (CROC), the Director of the Protocol Office, medical records, physicians, nurse practitioners, and other team members is necessary to keep abreast of all new clinical research operations related issues.
- Bachelor's degree.
- Four years of relevant experience.
- Master's Degree in health related field
- CCRA, CCRP, or CCRC certification
- Previous clinical research experience
- 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.
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