Administrative Director, Clinical Research Operations
UCI Chao Family Comprehensive Cancer Center (UCI CFCCC)
Responsible for the strategic planning, organizing and oversight of operations and resource management for the CFCCC clinical research enterprise, including the development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement. The AD-CRO is responsible for ensuring and maintaining an appropriate clinical research infrastructure and ensures that all institutional, local, state, and federal regulations, including good clinical practice requirements are met. The AD-CRO works directly with the CAO, Associate Director for Clinical Science and CTO Medical Director, and the Center Director, in defining and prioritizing specific needs related to the Center’s clinical research mission and in developing objectives and strategies to meet those needs.
Manage and oversee clinical research coordination, budget development, administration of the Disease-Oriented Teams (DOTs), Protocol Review and Monitoring Committee (PRMC) and the Data and Safety Monitoring Committee (DSMC), quality assurance for investigator-initiated studies, regulatory affairs support services, IND submissions, and ongoing data management. The AD-CRO will be responsible for tracking the overall protocol activation timeline and working with the CAO and Associate Director for Clinical Science toward efficiency and improvement wherever possible and/or necessary.
Serve as a subject matter expert on clinical research-related segments of the National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) Guidelines (e.g. Clinical Protocol and Data Management and Protocol Review and Monitoring System) and works closely with the CAO to provide guidance and recommendations to CFCCC senior leadership. The AD-CRO will have primary responsibility for the direction and leadership for development of the clinical research-related segments of the CCSG grant submission and will have management responsibility for the ongoing development and maintenance of all Standard Operating Procedures (SOPs) related to clinical research operations.
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