Clinical Operations Manager
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About The Position
Manages all activities associated with complex clinical research studies and provides leadership and advanced problem solving in support of the department's human subjects research regulatory operations and quality assurance. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. Creates and nurtures collaborations and partnerships with outside affiliate institutions, research sponsors, and various departments within the institution. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Responsible for review of studies for regulatory feasibility and ensure completion of regulatory requirements & client specifications. Will develop policies, SOPs and training programs for research staff throughout the department of Dermatology to ensure proper conduct and submission of human subject's research. This position supports the mission, vision and strategic plan of the Department of Dermatology. The manager will collaborate with the Director of the Dermatology Clinical Trials Unit to ensure exceptional clinical research support and a high level of professionalism and quality customer service. The Manager focuses others on a clearly defined, clearly communicated vision and engages individuals and groups to achieve that vision. The Manager identifies and develops organizational talent and embraces continuous learning of self and others. This is a one-year term position, with the opportunity for renewal based on funding availability and performance.
