What are the responsibilities and job description for the Quality Assurance Specialist, SCC position at UT Southwestern?
WHY UT SOUTHWESTERN?
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
JOB SUMMARY
Works under general supervision to produce daily quality assessment and quality assurance reports and information, including but not limited to, areas of licensure and accreditation from federal agencies and peer review organizations. Assists in the review and reporting of all adverse occurrences, which may be either patient, donor, recipient, or employee related. Collects, maintains, and organizes all relevant data that documents function and status of quality management processes or programs.
This position is to add a Quality Assurance Specialist (QAS) to the Investigator Initiated Trials (IIT) team. The QAS plans, organizes, and performs source data verification for 20% of enrolled subjects per the DSMC Plan and IIT Manual. The QAS prepares reports, reviews monitoring query responses, reviews corrective actions, and provides follow up. Monitoring of sub-sites identifies trends and provides critical data and overview to the PI which is required to ensure study oversite. This includes safety and data quality, adherence to the protocol requirements, regulatory compliance, and patient safety. The IIT study team is responsible for ongoing communication and training of sub-sites on new study developments. Other duties include review of submitted protocols, IC review, IIT management and protocol template review, SAE review and management, and to assist with eligibility review and reports to sponsors/funding source.
The Quality Assurance Specialist (QAS) will conduct clinical monitoring visits for our Investigator Initiated Trials (IIT) with sub-sites. The QAS plans, organizes, and performs source data verification for our IIT clinical trials. The QAS prepares reports, reviews monitoring query responses, reviews corrective action, and follows up on outstanding requests. This role includes Serious Adverse Event (SAE) review, reporting, follow up and spreadsheet maintenance for sub-sites. Other duties include review of submitted protocols, Informed Consent review, Protocol Template and IIT Management Manual review, assisting with eligibility review for enrollment into clinical trials, and assisting with reports to sponsors/funding source.
BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
PPO medical plan, available day one at no cost for full-time employee-only coverage
100% coverage for preventive healthcare-no copay
Paid Time Off, available day one
Retirement Programs through the Teacher Retirement System of Texas (TRS)
Paid Parental Leave Benefit
Wellness programs
Tuition Reimbursement
Public Service Loan Forgiveness (PSLF) Qualified Employer
Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATION
Required
Education
Associate's Degree or equivalent in health science discipline or
Experience
3 years of clinical experience with at least and
2 years in quality assurance, infection control, or risk management
JOB DUTIES
Assists administrative and technical personnel in developing, organizing, and evaluating quality management program goals and objectives.
Identifies and investigates with defined parameters; documents and reports all adverse occurrences and potential problems in conjunction with Quality Assurance Coordinator, Director and/or Medical Director.
Submits data trends and outcome assessments; assists in developing new measures as appropriate.
Organizes data gathering and prepares data reports.
Handles sensitive issues and medical/social information in professional and confidential manner from liability standpoint.
Performs other duties as assigned.
SECURITY AND EEO STATEMENT
Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
EEO Statement
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Benefits UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
PPO medical plan, available day one at no cost for full-time employee-only coverage
100% coverage for preventive healthcare – no copay
Paid Time Off, available day one
Retirement Programs through the Teacher Retirement System of Texas (TRS)
Paid Parental Leave Benefit
Wellness programs
Tuition Reimbursement
Public Service Loan Forgiveness (PSLF) Qualified Employer
Learn more about these and other UTSW employee benefits!
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
JOB SUMMARY
Works under general supervision to produce daily quality assessment and quality assurance reports and information, including but not limited to, areas of licensure and accreditation from federal agencies and peer review organizations. Assists in the review and reporting of all adverse occurrences, which may be either patient, donor, recipient, or employee related. Collects, maintains, and organizes all relevant data that documents function and status of quality management processes or programs.
This position is to add a Quality Assurance Specialist (QAS) to the Investigator Initiated Trials (IIT) team. The QAS plans, organizes, and performs source data verification for 20% of enrolled subjects per the DSMC Plan and IIT Manual. The QAS prepares reports, reviews monitoring query responses, reviews corrective actions, and provides follow up. Monitoring of sub-sites identifies trends and provides critical data and overview to the PI which is required to ensure study oversite. This includes safety and data quality, adherence to the protocol requirements, regulatory compliance, and patient safety. The IIT study team is responsible for ongoing communication and training of sub-sites on new study developments. Other duties include review of submitted protocols, IC review, IIT management and protocol template review, SAE review and management, and to assist with eligibility review and reports to sponsors/funding source.
The Quality Assurance Specialist (QAS) will conduct clinical monitoring visits for our Investigator Initiated Trials (IIT) with sub-sites. The QAS plans, organizes, and performs source data verification for our IIT clinical trials. The QAS prepares reports, reviews monitoring query responses, reviews corrective action, and follows up on outstanding requests. This role includes Serious Adverse Event (SAE) review, reporting, follow up and spreadsheet maintenance for sub-sites. Other duties include review of submitted protocols, Informed Consent review, Protocol Template and IIT Management Manual review, assisting with eligibility review for enrollment into clinical trials, and assisting with reports to sponsors/funding source.
BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
PPO medical plan, available day one at no cost for full-time employee-only coverage
100% coverage for preventive healthcare-no copay
Paid Time Off, available day one
Retirement Programs through the Teacher Retirement System of Texas (TRS)
Paid Parental Leave Benefit
Wellness programs
Tuition Reimbursement
Public Service Loan Forgiveness (PSLF) Qualified Employer
Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATION
Required
Education
Associate's Degree or equivalent in health science discipline or
Experience
3 years of clinical experience with at least and
2 years in quality assurance, infection control, or risk management
JOB DUTIES
Assists administrative and technical personnel in developing, organizing, and evaluating quality management program goals and objectives.
Identifies and investigates with defined parameters; documents and reports all adverse occurrences and potential problems in conjunction with Quality Assurance Coordinator, Director and/or Medical Director.
Submits data trends and outcome assessments; assists in developing new measures as appropriate.
Organizes data gathering and prepares data reports.
Handles sensitive issues and medical/social information in professional and confidential manner from liability standpoint.
Performs other duties as assigned.
SECURITY AND EEO STATEMENT
Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
EEO Statement
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Benefits UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
PPO medical plan, available day one at no cost for full-time employee-only coverage
100% coverage for preventive healthcare – no copay
Paid Time Off, available day one
Retirement Programs through the Teacher Retirement System of Texas (TRS)
Paid Parental Leave Benefit
Wellness programs
Tuition Reimbursement
Public Service Loan Forgiveness (PSLF) Qualified Employer
Learn more about these and other UTSW employee benefits!
