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 Primary Progressive Aphasia (PPA) observational research programs, in the laboratories of Dr. Emily Rogalski and Dr. Marsel Mesulam, and housed within the Mesulam Center for Cognitive Neurology and Alzheimer’s Disease. The Mesulam Center is world-renown for the care and research of PPA and attracts diagnosed persons from all over the globe for clinical evaluation, treatment, and research. The PPA Research Program at Northwestern is one of the first and largest studies on PPA to date, and recently received an additional five years of funding to continue work from the previous 15 years. This position will work directly with Drs. Rogalski and Mesulam to provide management and oversight for all components of the research program, including overseeing project and subject workflow, grant reporting, regulatory/IRB requirements, research staff supervision, subject recruitment, database management, reporting/analyzing data, providing data and support to external collaborators, monitoring research-related expenditures, and other special projects.
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.
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.
Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
Oversees recruitment and management of clinical research staff.
Completes applications and obtains appropriate approvals from various groups for all necessary study start-up functions.
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 assigning new protocols to coordinators and assistants. Assists with internal audits of research charts and data to ensure compliance with protocol requirements.
Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.
Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Manages project data including creation and management of databases, monitoring for data accuracy, and evaluation and analysis of data ensuring that results meet project information and deliverable objectives.
Analyzes, evaluates & interprets data to determine relevance to research
Monitors data use and storage to ensure compliance with current local, state, & federal regulatory guidelines, requirements, laws
Develops queries to access study-relevant clinical data from the EDW system as a power user, in compliance with FSM policies
Coordinates & participates in budgetary negotiations with industry sponsors.
Oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.
Assists with the management of research study budgets, which may include deciding on & approving expenditures of funds based on budget
Trains, directs, and assigns duties to clinical research and regulatory staff.
Acts as a mentor in regard to education of junior coordinators.
Monitor institutional and federal regulatory agency requirements related to clinical research training. Provide training to staff regarding federal, state and institutional requirements. Monitor skill level of staff in relation to non-procedural issues and provide instruction where necessary. Serve as a resource to the clinical research staff, evaluating opportunities to improve productivity and operational efficiency.
Performs other duties as assigned.
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 7 years' research study or other relevant experience required; OR
Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience.
Supervisory or project management experience required.
Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Excellent written and oral communication skills.
Strong organization and interpersonal skills.
Attention to detail / ability to work flexibly across multiple projects at a time.
Proficiency in STATA/SAS/R or other statistical software package
Microsoft Office (Word, Excel, PowerPoint, Access, Outlook)
Masters or PhD degree in Psychology, Neuroscience, Cognitive Science, or related field.
Preferred Competencies: (Skills, knowledge, and abilities)
Prior experience in managing human subjects research
Prior experience working with persons with dementia, aphasia, or other cognitive impairment
Prior experience with REDCap of similar database
Knowledge of medical/institutional research procedures
Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.