Quality Assurance Coordinator - Radiation Oncology - SCC
Department: Simmons Cancer Center
Full/Part Time/PRN: Full-Time
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information
Experience and Education
Bachelor's degree in appropriate health care discipline or device manufacturing, five (5) years clinical experience with at least two (2) in quality assurance, infection control, or risk management or five years industrial, pharmaceutical, or similar experience in quality assurance and at least two (2) years recent experience in quality assurance and biologic and device regulation, and certification as required by specific position.
Manage daily quality assessment and quality assurance programs, including but not limited to, areas of licensure and accreditation from federal agencies and peer review organizations. Responsible for review and appropriate reporting of all adverse occurrences, which may be either patient, donor, recipient, or employee related. Collects, maintains, organizes, and presents all relevant data that documents function and status of quality management program.
Assists administrative & technical personnel to develop, organize, & evaluate quality management program goals and objectives.
Identifies and investigates with defined parameters: documents and reports, all adverse occurrences, and potential problems to Director or Department Chair, and as may be required with university administrative offices.
Provides working supervision to group of administrative and/or technical positions.
Submits data trends and outcome assessments; develops new measures as appropriate.
Organizes data gathering and facilities data review; prepares data reports.
Makes recommendations for problem resolutions.
Coordinates staff education programs and training seminars as necessary.
Manages sensitive issues and medical/social information in in professional and confidential manner from liability standpoint.
Clinical trial auditing and clinical quality assurance experience is preferred.
In-depth knowledge and experience in the application of good clinical practice (GCP) requirements is required (ICH, FDA, etc), as is familiarity with the essential documents related to clinical research studies.
Conduct internal audits to identify non-compliance in adherence to protocols, SOPs, regulations, and GCPs.
Write/revise SOPs, as needed.
Assist manager in the development of education programs for the clinical research team.
Ensure audit results are formally recorded, reported and corrective/preventive actions are documented.
Certified Quality Auditor, CCRA, or equivalent certification preferred.
Performs other duties as assigned.
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; gender, including sexual harassment; age; disability; citizenship; and veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.