The Research Operations and Conduct (ROC) section within the OCR is responsible for the day-to-day operations of: training and education; quality assurance; research billing compliance; regulatory compliance and other compliance and oversight related activities. The Director- ROC is an integral member of the OCR management team and assists the Director- OCR in establishing standards and practices that will ensure compliance while facilitating the conduct of clinical trials.
Direct the operations of regulatory compliance programs in one or more departments or clinics through managers.
Lead strategic planning for programs, including setting goals and objectives.
Supervises and provides direction and leadership to program managers.
Develops systems to identify areas of risk including development of new IT programs.
Reviews and approves corrective action plans.
Initiates internal audits. and oversees interactions with regulatory agencies during external audits.
Directs compliance documentation submission and maintenance, compliance training, compliance committee formation, and other programmatic functions.
Serves as the primary liaison with other University units.
Serves as an expert resource to senior management on specified compliance and operational issues.
Leads the development and oversight of compliance program budgets.
Participates in and develops written components of specialization-related grant proposals and participates in various institutional committees, such as Institutional Review Board (IRB) and Certified Compliance Professional Physician (CCPP).
Directs training for new fellows.
Knowledge of policies, procedures and legislation concerning human subjects in research and a basic understanding of the Code of Federal Regulations required.
Expert knowledge of ICH/Good Clinical Practices and regulations of clinical research set forth in the Code of Federal Regulations, the Office for Human Research Protections, Food and Drug Administration, National Institutes of Health and Center for Medicare and Medicaid Services or other relevant agencies required.
Excellent communication and presentation skills required.
Ability to interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies required.
Ability to network and interact, as well as support effective partnerships with key groups and individuals required.
Knowledge of Microsoft Word, Excel, Outlook and PowerPoint software required. Excellent organizational skills required.
Ability to work with minimal supervision and function as a team member required.
Attention to detail required.
Ability to prepare accurate documentation of events required. Ability to maintain confidential material and information required.
Excellent written and verbal communication skills to effectively interface with pharmaceutical industry, the hospital and departments within the Division required.
Ability to resolve issues, problem solve and make effective recommendations required.
Education, Experience and Certifications:
Bachelor's degree required.
Advanced degree preferred.
Minimum of three years clinical trial management or other equivalent experience required.
Minimum of five years management or research administration experience required.
Experience with regulations related to the conduct and monitoring of clinical trials, data management and research program management required.
Supervisory experience required.
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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Internal Number: JR04105
About University of Chicago
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