Clinical Operations Manager

3 weeks ago

Chicago, United States Northwestern University Full time

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).

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 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.
- Recruit, hire, train, and supervise junior clinical research staff.
- Technical_
- Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
- Directly involved with study start-up, implementation, conduct, and close-outs.
- Oversees completion of study activities per protocol. Guides clinical research coordinators in collaborating with local clinical staff and Principal Investigator (PI).
- Manages day-to-day activities of clinical research team and oversees interaction with critical clinical partners such as physicians, radiologic technologists, nursing staff, etc.
- Ensures that the conduct of study protocols is in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of the study or study sponsors.
- Leads research staff in preparing for internal, NU IRB, Sponsor, and/or FDA audits.
- Develops and maintains standard operating procedures for clincical research staff and also monitors compliance with procedures.
- Administrative_
- Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
- Oversees recruitment and management of clinical research staff.
- Plans, develops & implements new processes, policies, and protocols to support research studies & maximize/extend study capabilities.
- Provides supervision of day-to-day research activites and manges administrative issues related to work load for the staff, including activities such as tracking current and expected workloads and ass

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