Department: Research Services
Position Summary: The Director of the Office of Clinical Trials (OCT) at the University of North Carolina at Chapel Hill (UNC-CH) is responsible for the daily management and operations of clinical trial financial, regulatory and compliance services to all UNC-CH. The Director will oversee and assume responsibility for clinical trial billing compliance, appropriate identification of charges billable to third party payers, contract negotiation budget development, feasibility analysis, regulatory support, and ongoing post award management and monitoring for clinical trials. This position reports directly to the Associate Vice Chancellor for Research, and will work in close collaboration with the Directors of Research Compliance, Office of Sponsored Research, the Office of Human Research Ethics (where the Institutional Review Boards are located), and UNC Health Care. Other areas of responsibility include: Ensure the creation and quality review of Medicare Coverage Analyses for all clinical trials Oversee the process to register all clinical trials and link all clinical trial participants in the institution's central clinical trial management system(s); and work with campus units to ensure that clinical research income is properly received and accounted for in institutional financial systems. Ensure that clinical trials are registered in the federal clinicaltrials.gov repository, as required. Facilitate timely and appropriate communication with Principal Investigators and Research Nurses Coordinators on all aspects of clinical research administration Expand the regulatory Monitoring Program and the Research Subject Advocacy Program to ensure compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) regulations and the Informed Consent process. Develop, organize, and or conduct clinical research administration and regulatory educational programs Lead continuous process and operational improvement initiatives to reduce cycle-times, improve overall compliance posture, and remove unnecessary administrative burdens. Establish key operational metrics and publish periodic performance reports to stakeholder groups. The Director will also ensure that the office provides knowledgeable, friendly, professional and timely support to faculty and staff. This individual is also responsible for safeguarding UNC-CH's interests by assuring compliance with various Federal and State regulations and laws, as well as Institutional policies associated with management of clinical trials. This position will be responsible for developing, in consultation with the Associate Vice Chancellor for Research and the campus community, policies and procedures relating to corporate sponsored clinical trials. The ability to manage a diverse staff of clinical trials experts and have a deep understanding of the clinical trial process and the impact of OCT operations on that process is required
Education Requirements: Graduate degree preferred, Bachelor's degree required with a minimum of 5 years of clinical research, or the equivalent, and prior experience supervising staff.
Qualification and Experience: A strong clinical research regulatory background as well as excellent written and oral communication skills, including the ability to speak in front of groups is essential. Knowledge of clinical research regulations and Federal and State law governing clinical research and tax-exempt organizations is required. Knowledge of Federal healthcare and commercial insurer billing regulations is strongly desired. Knowledge of computer databases and general computing software is essential, and experience with clinical trial management systems is desired.
Department Contact Name and Title: Jo Ann Gustafson, Director of Operations
Department Contact Telephone Number or Email: email@example.com