This position manages all activities associated with biomedical and/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; and/or multi-million dollar budgets. Ensures completion of contract requirements and client specifications. Oversees day-to-day operations including identifying and securing needed resources. Creates, implement, monitors and updates project plans. Facilitates meetings with appropriate parties. Tracks tasks/deliverables to ensure timelines, milestones and/or goals are attained. Monitors and reports progress as appropriate. Resolves and/or escalates issues in a timely manner. Co-authors scientific papers for presentation and publication and coordinates writing, submission and administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy and procedure developed by the NU Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).
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.
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.
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.
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.
Assist with development and build of study related databases
May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget.
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.
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.
Supervisory or project management experience required.
Must complete Northwestern'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
7 years practical research study or related experience
Experience working with the cardiovascular population
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
As per Northwestern University policy, this position requires a criminal background check. Successful applicants will need to submit to a criminal background check prior to employment.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 33287
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.