Clinical Research Project Manager jobs in United States
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Northwestern University · 3 days ago

Clinical Research Project Manager

Northwestern University is a prestigious institution specializing in neurological diseases and cognitive research. They are seeking a Clinical Research Project Manager to oversee complex biomedical and social-behavioral research studies, ensuring compliance with regulations and successful project execution.

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Responsibilities

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)
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
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
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
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
Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows
Acts as a mentor in regard to education of junior coordinators
Performs other duties as assigned

Qualification

Clinical ResearchAlzheimer’s Disease KnowledgeProject ManagementStatistical AnalysisBudget ManagementData ManagementRegulatory ComplianceMentoring

Required

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
Demonstrated knowledge of Alzheimer's disease and the related dementias
Demonstrated knowledge of federal and state regulations governing the participation of human subjects

Preferred

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

Benefits

Meaningful, competitive, high-quality health care plans
Retirement benefits
Tuition discounts
Comprehensive programs and services to help you and your family navigate life’s challenges and opportunities
Flexible work arrangements
Programs to help you locate and pay for quality, affordable childcare and senior/adult care
Employee career development

Company

Northwestern University

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Northwestern University is a private research and teaching university that offers academic programs across various fields of study. It is a sub-organization of Northwestern Athletics.

H1B Sponsorship

Northwestern University has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (325)
2024 (308)
2023 (280)
2022 (282)
2021 (184)
2020 (155)

Funding

Current Stage
Late Stage
Total Funding
$98.02M
Key Investors
National Peanut BoardAdvanced Research Projects Agency for HealthGRAMMY Museum
2024-10-30Grant
2024-10-04Grant· $34M
2023-11-28Grant· $0.02M

Leadership Team

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Diego Klabjan
Professor
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Henry Bienen
Interim President
Company data provided by crunchbase