Associate Director, Study Start Up & Billing 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 2,600 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.

Occupational Summary
Assist the Director of Research Operations and the Associate Dean of Clinical Research with responsibilities associated with Study Initiation, Coverage Analysis and Research Charge Adjudication. Serve as liaison and subject matter expert for clinical research study start up, research billing and charge review. Facilitate collaborations across the Schools of Medicine and Nursing and Duke Health on behalf of DOCR. Lead and implement initiatives and programs to ensure high quality and efficient study start up processes, including calendar-building and coverage analysis. Ensure accurate and timely adjudication of all DUHS and Non DUHS charges under DOCR Central Charge Review. Lead and provide direction to staff who perform study start up, coverage analysis determination and research charge review activities to include: supervision and management of staff, forecasting hiring, development and review of processes, input for budget development, and education and training of staff. Guarantee adherence/compliance with federal regulations/guidelines, state laws and local policies and procedures around clinical research billing. Advise appropriate institutional officials of deficiencies, provide metrics as requested, recommend necessary corrective actions, and monitor with follow up to ensure that needed actions have been implemented.

Work Performed
Essential Duties

Leadership, Strategic Planning, and Management

Act as the subject matter expert and liaison among internal DOCR resources (Maestro Care for Research, OnCore), other Duke entities (DUHS Compliance, ORC, ORAQ, DHTS and PRMO) and researchers across the organization in matters regarding study start up, research billing and charge review operations.

Assist directors with financial oversight, budget management, personnel and staffing, space and facilities, and DOCR initiatives. Provide oversight regarding customer stewardship; expectations management; and development, management, and analysis of satisfaction metrics to provide suggestions for customer service improvements.

Work closely with Clinical Research Unit research and financial practice managers to determine CRU clinical research study start up process needs and develop standardized delivery models. Interface with CRU directors on research process plans to seek guidance and buy-in for initiatives.

Participate in the development of communications to improve understanding of policies and practices for the research community through newsletter, CRU newsletter, DOCR website and portal, and other
 
School of Medicine Communication Channels. Spearhead project plans and initiatives of DOCR including regulatory compliance, roles and responsibilities, GCP, and other research domains.

Represent Duke in local and national professional associations by serving on committees and presenting at conferences; stay current with regulatory standards and contribute to the knowledge of the profession.

Oversee staff on the Study Initiation and Central Charge Review teams in their assigned internal responsibilities. Perform routine personnel functions, including but not limited to time and attendance monitoring, hiring, performance appraisals, promotions, space management and staff development assessments. Resolve problem situations related to staffing, onboarding, and management of employees. Identify and develop potential career paths and growth opportunities for team members, including identifying opportunities for training, mentoring, shadowing, participation in workshops, and presentation development.

Operations

In collaboration with the OnCore and Maestro Care teams, lead processes to streamline study start up and billing/charge review process and oversight in OnCore and Maestro Care. Ensure compliance with IRB, University, and applicable sponsor and payor regulations.

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