Clinical Research Project Manager
Department: MED-Mesulam Ctr Cog Neur & Alz
Salary/Grade: EXS/7
Target hiring range for this position will be between be Salary range is as be $63,079-$88,705 per year . Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.
Job Summary:
The Cognitive Neurology and Alzheimer's Disease Center (CNADC) 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, dementia, Alzheimer's disease, frontotemporal degenerations, primary progressive aphasia, and related neurodegenerative conditions. 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.
Manages all activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. 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. May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. 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).
Specific Responsibilities:
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.
- Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.
- Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
- Ensures that study protocols are 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 sponsors. Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
- Reviews scientific literature & evaluates & recommends applicable techniques & procedures.
Administrative
- Analyzes, evaluates & interprets data to determine relevance to research.
- Assists PI in developing statistical methods & models to analyze & report data based upon study requirements.
- Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.
- Creates data for use in grant submission & develop new proposals for research including obtaining financial support.
- Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
- Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Data
- Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
- Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
Finance
- May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget.
- Monitors accounts.
- Purchases supplies, materials, equipment & services.
- Maintains inventory of study supplies
- Ensures appropriate allocation & compliance.
- Invoices study sponsors for study tests/procedures.
- Coordinates & participates in budgetary negotiations with industry sponsors.
Supervision
- Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows.
- Acts as a mentor in regard to education of junior coordinators.
Miscellaneous
Performs other duties as assigned.
Minimum Qualifications: (Education, experience, and any other certifications or clearances)
A bachelor's degree in a social or health science + 5 years experience; or 7 years practical research study or related experience; or a master's degree in a social or health science + 3 years experience is required.
Supervisory or project management experience required.
Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Demonstrated knowledge of Alzheimer's disease and the related dementias
Demonstrated knowledge of federal and state regulations governing the participation of human subjects.
Preferred Qualifications: (Education and experience)
A bachelor's degree in a social or health science + 5 years experience or a master's degree in a social or health science + 3 years experience
Supervisory or project management experience required specifically with NIH grants.
Experience administering neuropsychological tests.
Preferred Competencies: (Skills, knowledge, and abilities)
Ability to train people for current assignment and mentor them in all aspects of research policy and procedures at a higher education institution.
Ability to work effectively in an environment in which parameters may change daily and to adjust behavior to meet the needs of different people and situations
Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at [click to reveal website link] to learn more.
Work-Life and Wellness:
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Professional Growth & Development:
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Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement . Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process .