Department: MED-Center for Healthcare Studies Salary/Grade: EXS/7
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).
This Clinical Research Project Manager will work on a federally funded research project evaluating a novel diabetes toolkit to improve diabetes care. The primary responsibility of this position will be to help execute a pragmatic clinical trial to test the toolkit in the clinical setting at Northwestern Medicine. The manager will plan on working with collaborators across Northwestern University and Northwestern Medicine (McCormick School of Engineering, Center for Health Services and Outcomes Research, Division of Endocrinology, Northwestern Quality) and with collaborators in other university health systems. The manager will be responsible for several aspects of the clinical trial including protocol development, IRB, recruitment, consenting, chart review, survey administration, and data management. The Clinical Research Project Manager would be expected to contribute ideas and take the initiative to help execute all aspects of the clinical trial, including pre-implementation, implementation, and the full pragmatic trial. The Clinical Research Project Manager will oversee day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, and updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones and/or goals are attained; monitoring & reporting progress as appropriate; and resolving or escalating issues in a timely manner. The manager may co-author scientific papers for presentation, publication, and may coordinate writing, along with submission and administration of grants. The candidate will need to ensure that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy & 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).
The successful candidate will have prior experience working in clinical trials or pragmatic trials, be exceptionally detail-oriented, will need to collaborate effectively as an individual and in a team and contribute to building a positive team culture, have strong writing and critical thinking skills, be creative and thoughtful in proposing ideas to achieve the study goals, and be technologically proficient with the ability to learn and navigate electronic medical record systems and project databases. Candidates with prior clinical experience and prior research experience are preferred.
Provides 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. . Closely monitors & documents patient's adverse events; partners with nursing staff.
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.
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.
Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Direct first-hand IRB knowledge/skills for > 6 months
Previous clinical trials experience (including consenting and recruitment)
Proficiency in Microsoft Office Suite Applications, including Excel and PowerPoint
Motivated with ability to work independently, and with team skills to work in small and large teams/groups across disciplines (medical, engineering, quality/patient safety)
Experience or previous education in public health OR chronic disease care/management OR healthcare quality/patient safety
Experience with electronic data warehouse queries for clinical research
Prefer experience with research utilizing interventions that also have software component or previous website management/design experience
Preferred Competencies: (Skills, knowledge, and abilities)
Direct first-hand IRB knowledge/skills for > 6 months for clinical trial(s)
Previous experience or knowledge of REDCAP or equivalent database(s) (Access)
Previous experience with administration of research or clinical surveys
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: 38530
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.