Northwestern University · 2 days ago
Clinical Research Project Manager
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$63K/yr - $77K/yr
3+ years expNorthwestern University is a leading institution in research and education, and they are seeking a Clinical Research Project Manager. The role involves managing complex biomedical and social-behavioral research studies, ensuring compliance with regulations, and overseeing project operations and budgets.
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Responsibilities
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
Negotiates prices & specifications with vendors
Purchases supplies, materials, equipment & services
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
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
Computer literate in Microsoft Office, Internet, and database use
Ability to establish and maintain effective working relationships with physicians, affiliate centers and coworkers
Excellent written and oral communication skills
Strong organization and interpersonal skills
Preferred
Knowledge of data management and case report form development preferred
Experience collaborating with multiple sites in clinical research
Understanding of the clinical trial start-up process
Strong regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines
2 years prior experience coordinating or monitoring therapeutic clinical trials
2 years prior experience in clinical trial development
Experience with data completion or familiarity with data form completion guidelines
Experience in staff education and training activities
Prior experience in a cancer research setting preferred
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
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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