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; and/or multi-million dollar budgets. The Clinical Research Project Manager ensures completion of contract requirements and client specifications. This role oversees day-to-day operations including identifying and 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 and reporting progress as appropriate; and resolving or escalating issues in a timely manner. May co-author scientific papers for presentation, publication and coordinates writing, submission and administration of grants. This role also 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 Northwestern University’s Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
Provides complex scientific and technical leadership in determining research priorities and the plan, design and execution of research projects ensuring that programs of investigation meet specified objectives.
Plans, develops, implements new processes and protocols to support research studies and maximize/extend study capabilities.
Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment and eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines and organizes patient's treatment and test schedules.
Ensures that study protocols are in compliance with appropriate rules, regulations and 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 and procedures. Closely monitors and documents patient's adverse events; partners with nursing staff in modifying dosages, tests and treatment schedule.
Reviews scientific literature, evaluates and recommends applicable techniques and procedures.
Analyzes, evaluates and interprets data to determine relevance to research.
Assists PI in developing statistical methods & models to analyze & report data based upon study requirements.
Prepares results and may co-author scientific papers for presentation, publication and 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 and/or other research and/or educational institutions.
Ensures that all study documents associated with current local, state, and federal regulatory guidelines, requirements, laws and research protocols are completed in a timely manner.
Manages project data including processing, accuracy, analysis and 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 and final reports.
Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
May create and/or manage research study budget which may include deciding on and approving expenditures of funds based on budget.
Negotiates prices and specifications with vendors.
Purchases supplies, materials, equipment and services.
Ensures appropriate allocation and compliance.
Invoices study sponsors for study tests/procedures.
Coordinates and participates in budgetary negotiations with industry sponsors.
Trains, directs, assigns duties to and may supervise lab EEs, students, residents and/or fellows.
Acts as a mentor in regard to education of junior coordinators.
Supervises staff across three programs.
Manages implementation of human resource programs, policies, procedures and talent management lifecycle and related mentoring and training.
Oversees recruitment and selection process; Performance Excellence plan for each employee; and merit increase process.
Manages and provides consultation regarding complex performance problems and issues; administers leaves; approves timesheets and oversees completion of annual staff Conflict of Interest survey.
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 Northwestern University's IRB CITI training before interacting with any participants and must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Prior experience in running clinical trials.
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: 36276
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.