Clinical Research Project Manager

Department: MED-Clinical Trials Unit
Salary/Grade: EXS/7

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).

On site activity required 4-5 days per week per clinical requirements

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. 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.
• May manage submission of regulatory documents to the IRB, including development of informed consent forms.

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.
• Develops and supports build of study related databases

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.
• May supervise study staff members.

Miscellaneous

Performs other duties as assigned.

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

• 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.

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

• Computer Proficiency, especially Microsoft Word and Excel
• Demonstrates ability to work on multiple projects simultaneously
• Excellent communication skills

Preferred Qualifications: (Education and experience)

• Experience working with the cardiovascular population
• Experience coordinating IND and IDE studies

Preferred Competencies: (Skills, knowledge, and abilities)

• Enhanced clinical understanding of the cardiovascular population
• Familiarity with hospital electronic systems (i.e. electronic medical records)
• Experience building research databases

Target hiring range for this position will be between $63,079 - $78,849 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Benefits:
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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 .