COORDINATOR, QA & COMPLIANCE

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

The Department of Surgery is looking for a Coordinator, QA and Compliance for Duke Vaccine Immunogenicity Programs (QADVIP). QADVIP currently manages the quality assurance work for approximately 19 active grants/contracts across Surgery, DHVI, and CEPI. This position will perform SOP, QMP, study plan review, perform GCLP training, plan and conduct audits, perform key quality indicators, deviations, monitoring, archiving, and report writing.

Minimum Requirements:

• Requires a bachelor’s degree in a science related filed to acquire the appropriate cognitive, communicative and statistical reporting skills.
• Requires two years of experience in clinical laboratory analysis, clinical laboratory quality assurance or related position. A related master’s degree may offset years of experience on a 1:1 basis.

Other Requirements:

• This position is hybrid eligible. The position is partially remote, and the employee must reside in a Duke University-approved state.

Be Bold.

Position Description:

• Perform a variety of complex and independent activities involved in the collection, analysis, documentation and interpretation of data related to departmental quality assurance, quality control, safety management and compliance with federal and state regulations.
• Evaluate and interpret collected data and prepare written reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions.
• Develop forms and procedures to track and compile information and apply appropriate data analysis techniques; maintain computerized patient data base for tracking quality assurance statistics.
• Confer with the Director of Quality Assurance and Compliance Affairs in the design and review of reporting procedures to serve the purposes of quality assurance; determine the validity and appropriateness of quality assurance criteria and measures utilized by the department; make appropriate recommendations to the medical staff.
• Stay abreast of new developments in the field of Quality Assurance and Quality Control; recommend new policies and revise existing policies/procedures for compliance standards.

 

Choose Duke.

The Duke Department of Surgery has gained a reputation as one of the leading surgery programs in the world. The number and variety of active clinical trials in the Department of Surgery allows us to offer our patients access to treatments and therapies that are available at only a few medical centers nationwide. Join our award-winning team and be part of an inclusive culture that is committed to providing outstanding patient care, training tomorrow’s leaders, and conducting innovative research. You'll also benefit from Duke's competitive benefits package, including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Screening of Applications: Screening continues until the position is filled.

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $ 63,473.00 to USD $94,860.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate 's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations