Job Description

The Yale Center for Clinical Investigation (YCCI) seeks a Associate Director with an exceptional ability to lead and manage infrastructure for clinical research and training. The incumbent will be expected to manage and lead the operations and service components of the Study Design and Epidemiology team within the Protocol Design, Development, and Feasibility (PDDF) for YCCI. The Assoc Director will be expected to lead the Study Design team in PDDF in a manner responsive to the needs and interests of a complex group of faculty and trainees in the process of conceptualizing, designing, and developing rigorous clinical research protocols. The specific areas of consultation and responsibility for the PDDF include intake, project navigation, protocol development, biostatistics, data management, project management for investigator-initiated trials, feasibility analysis, and regulatory requirements. The PDDF will be expected to work collaboratively with the YCCI Protocol Activation and Lifecycle Management and Regulatory and Compliance groups within YCCI to ensure that the research protocols have timely, transparent, and seamless transitions in the early stages through execution and completion. The Assoc Director will be expected to work productively with the Section of Bioinformatics and Data Science (BIDS) and the Yale Center for Analytical Science (YCAS) to develop and implement robust triage processes for investigators who require deeper expertise than that available with PDDF or need a more sustained and substantial consultative relationship to execute their research protocol.Ideal candidates should have a track record of successfully leading comparable research organizations within academic institutions; experience working with and supervising staff to optimize the complex workflow necessary to conceptualize, activate, execute, and complete clinical research protocols that employ different forms of research methodology; insuring that clinical research protocols are conducted in compliance with institutional and governmental regulatory requirements to protect human research participants; utilize relevant technology to securely store, curate, and access research records of human subjects; promote a diverse staff and workforce development strategies; and create respectful, expert, and timely work performance by all members of the staff in the Study Design team within PDDF in support of the center’s service obligations. The incumbent will work collaboratively with university officials on policies, finance, personnel, technology, space, legal, and regulatory matters.