Northwestern University · 7 hours ago
Clinical Research Project Manager
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$63K/yr - $85K/yr
3+ years expNorthwestern University is a leading educational institution, and they are seeking a Clinical Research Project Manager to oversee complex biomedical and social-behavioral research studies. The role involves managing day-to-day operations, ensuring compliance with regulations, and collaborating with various stakeholders to achieve research objectives.
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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
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
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
Negotiates prices & specifications with vendors
Ensures appropriate allocation & compliance
Coordinates & participates in budgetary negotiations with industry sponsors
Acts as a mentor in regard to education of junior coordinators
Performs other duties as assigned
Qualification
Required
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 5 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 3 years' research study or other relevant experience
Supervisory or project management experience required
Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
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
Variety of tools and resources for professional growth
Company
Northwestern University
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.
5001-10000 employees
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 StageTotal Funding
$98.02MKey Investors
National Peanut BoardAdvanced Research Projects Agency for HealthGRAMMY Museum
2024-10-30Grant
2024-10-04Grant· $34M
2023-11-28Grant· $0.02M
Leadership Team
Diego Klabjan
Professor
Henry Bienen
Interim President
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