The Simon Research Lab and the Center for Health Equity Transformation within the Department of Obstetrics and Gynecology seek a full-time Clinical Research Project Manager to join a dynamic and fast-paced research environment. The Clinical Research Project Manager 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 Clinical Research Project Manager will support a broad portfolio of research and health equity programs and research initiatives.
The Simon Research Lab and the Center for Health Equity Transformation are dedicated to promoting health and health care equity. For more information about the Simon Research Lab, please visit http://labs.feinberg.northwestern.edu/simon/. For more information about the Center for Health Equity Transformation, please visit https://www.feinberg.northwestern.edu/sites/chet/.
Note: Work environment may include working remotely, and occasional project events may occur during over weekends/evenings.
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.
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.
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.)
Strong project management experience and proven ability to strategize, think operationally, organize, and implement research programs.
Excellent problem-solving and analytical thinking skills.
Excellent writing skills.
Excellent listening, communication, and presentation skills.
Strong organizational skills & attention to detail.
Strong foundation in research methodology.
Track record in working successfully in diverse range of ethnic, cultural, and economic communities.
Proven ability to work in teams and foster collaborative environments.
Strong personal initiative and ability to work independently.
High degree of professionalism.
Preferred Qualifications: (Education and experience)
A master's degree in health science, social science, or education.
Experience mentoring diverse youth/students.
Experience working on large collaborative projects and/or with teams that span multiple sites.
Preferred Competencies: (Skills, knowledge, and abilities)
Proficiency in multiple languages.
Ability to work independently.
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: 38788
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.