QA & REGULATORY COMPLIANCE ASSOC

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Duke University Job Description

Job Title: QA & Regulatory Compliance Associate

Occupational Summary:

Coordinate DOCR’s portion of the institutional approval process for new clinical research studies. Review study documents to complete required start-up build in OnCore and meet with study teams to review the billing grid prior to the study protocols being built in Maestro Care.  Collaborate with teams inside and outside of DOCR to assess study readiness to go-live. Provide guidance and training to Clinical Research Analysts regarding protocol interpretation, calendar creation, Medicare coverage analysis, and clinical research workflows. Investigate questions related to research activities in OnCore and Maestro Care and identify best practices.

Responsibilities:

Help with oversight of build assignment and metrics for research order sets and Beacon research treatment plans. Maintain OnCore data elements for tracking build and monitor the DOCR Support Service Now queue. 25%

Build calendars, perform coverage analysis, and conduct initiation meetings for high-complexity studies; assess their operational needs and coordinate with PRMO and the Research Maestro Care team to build the protocols in Maestro Care. 20%

Review amendment and correction requests for high-complexity studies, make the necessary calendar changes in OnCore, and coordinate with PRMO and the Research Maestro Care build team to make the appropriate changes in Maestro Care (if applicable). 5%
Field OnCore and Maestro Care questions from the research community as they relate to start-up workflows 5%

Review new studies to assess their operational needs (OnCore, Maestro Care builds) and coordinate the Maestro Care build process. 10%

Working closely with the DOCR charge review team and PRMO Clinical Trials Billing Office, investigate questions related to research billing, identify best practices, and oversee resolution of complex research billing issues. 5%

Provide guidance and training to Clinical Research Analysts regarding protocol interpretation, calendar creation, Medicare coverage analysis, and clinical research workflows 30%

Supervisor

This position reports to the Associate Director, Maestro Care for Research.

Required Qualifications at this Level

Education

Work requires graduation from an accredited degree program in a clinical
field such as a Registered Nurse (RN), Physician's Assistant (PA) or
Pharmacist plus two years of healthcare experience, or one of the
following equivalents:

1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in
Clinical Trials Research related curriculum plus a minimum of five
years clinical and/or research experience; or

2. Completion of a bachelor's degree in a field related to health
science and a minimum of three years of clinical and/or research experience.