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Clinical Operations Manager

at Northwestern University in Chicago, Illinois, United States

Job Description

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Job ID50294

LocationChicago, Illinois

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Department: MED-Mesulam Ctr Cog Neur & Alz
Salary/Grade: EXS/8

Job Summary:
Manages all activities associated with complex clinical research studies and provides leadership and advanced problem solving in support of the department's research program and mission.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 logistical and financial feasibility and ensures completion of contract requirements & client specifications. Will develop policies, SOPs and training programs for research staff throughout the department to ensure proper conduct of human subjects research.This position will additionally provide statistical and data reporting expertise for a variety of projects within department, including data management, analysis, and summarizing/communicating results across multiple projects and disciplines. May additionally co-author scientific papers for presentation & publication & as well as assist with writing, submission & administration of grants.
The Mesulam Center for Cognitive Neurology and Alzheimer's Disease is a multi-departmental component of the Feinberg School of Medicine. We specialize in the clinical care and scientific study of neurological diseases that interfere with cognition and behavior. Areas of emphasis include age-related memory impairments and dementias. Our three interacting missions are to investigate the causes and clinical characteristics of neurodegenerative diseases, to ensure that our patients are the beneficiaries of the latest advances, and to explore the neural foundations of behavior and cognition in health and disease.
This position will serve as the Manager for the Clinical Trials Unit, directed by Dr. Ian Grant, and housed within the Mesulam Center for Cognitive Neurology and Alzheimer's Disease. The Clinical Trials Unit currently works on several interventional and observational studies with subjects that have subjective complaints of memory loss, Mild Cognitive Impairment (MCI), Early Onset Alzheimer's Disease (EOAD), mild to moderate Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), and semantic variant Primary Progressive Aphasia (svPPA).
This position will work directly with Dr. Grant to provide management and oversight for all components of the Clinical Trials Unit to ensure all milestones and goals are met. This position will ensure completion of contract /sub-contract and sIRB requirements. It will also include oversight of clinical operations and logistics. The manager will collaborate with the department leadership 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.
Please note: Supervisor provides objectives and deadlines.Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures.EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.
Specific Responsibilities:
Program Development
Assists with determining goals, objectives, outcome measurements and metrics, financial feasibility, and collaboration opportunities as it relates to clinical research with other internal and external organizations.Implements policies, procedures, and training for clinical research within the department.
Directs actions to ensure high quality clinical research standards are maintained across all department divisions.
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Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply.         
        
        

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Job Posting: 12078513

Posted On: Jul 26, 2024

Updated On: Jul 26, 2024

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