Clinical Research Project Manager

Department: SoC Comm Sciences & Disorders
Salary/Grade: EXS/7

The expected pay for this position is $85,000, in alignment with departmental equity and market data.

Job Summary

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).

The Early Intervention Research Group (EIRG) is led by Dr. Megan Roberts. This lab examines the effects of early intervention for children with developmental delays (6 months to 4 years). The EIRG uses a variety of methodologies including clinical trials, behavioral observations, and surveys. Data is longitudinal with multiple measures at each time point. Because the EIRG blends research and clinical practice, this position requires a flexible and creative thinker who can work as part of an interdisciplinary team.

This position requires someone with a strong attention to detail who can also consider the big picture. The position includes conducting standardized assessments, delivering evidenced-based language interventions to children and their caregivers, and coordination with community partners, and additional research tasks, such as coding data and entering/verifying data. We are looking for someone who can connect well with both young children and their caregivers. We are also looking for a team player who prefers open and honest communication and is willing to take initiative and learn a variety of lab related responsibilities, including data entry, data quality checks, scoring assessments, and transcribing and coding parent/child interactions or therapist/child/parent interactions.

Principal Accountabilities

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.
• 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.

• Performs other duties as assigned.

Minimum Qualifications: (Education, experience, and any other certifications or clearances)

• 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.

Minimum Competencies: (Skills, knowledge, and abilities.)

• Previous experience managing large studies.

Preferred Qualifications: (Education and experience)

• Bachelor's degree in psychology or related field or organizational management within a research context.
• Experience managing research.
• Experience managing teams of people with several direct reports.
• Experience with data and database management.
• Experience working with families and children.
• Outstanding written and spoken communication skills in English. The role requires someone with a strong research and clinical background to help manage several projects.

Preferred Competencies: (Skills, knowledge, and abilities)

• 3-5 years research study experience.
• Speaks Spanish

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.