Department: MED-Medical Social Sciences Salary/Grade: EXS/7
The Clinical Research Project Manager role 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).
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.
Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.
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.
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.
Performs other duties as assigned.
Successful completion of a 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.)
Excellent interpersonal skills and ability to work in a multi-disciplinary team.
Ability to collaborate with professionals across sites to accomplish work.
Preferred Qualifications: (Education and experience)
PhD or Masters with 3 or more years experience in a health or social science field.
Experience with patients, clinicians, investigators, and the public in the conduct of collaborative research.
Experience with software required to manage large studies, patient tracking, and databases.
Experience with patient-reported outcome implementation and use in clinical settings.
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: 36495
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.