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Research Project Manager
3 months ago
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).
Please note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.
**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.
- 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.
- 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.
- Finance_
- 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.
- 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**:
- 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.
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Benefits:_**:
**_ 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._
**_ Professional Growth & Development:_**:
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