Manages daily operations of a biomedical and/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors and other external project stakeholders. Monitors study performance, analyzes and review results, and supervises development and implementation of new protocols. Assigns work and supervises study staff and reviews technical operations ensuring that all processes, protocols and procedures are quality controlled and functioning up to standards. May co-author 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).
Leads execution and control of a biomedical and/or social science project or research study.
Manages and ensures completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment and eligibility requirements; interviews participants and obtains social and medical histories; based on results determines and registers participants with appropriate sponsors; completes informed consent; determines and organizes patient's treatment and test schedules.
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.
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.
Manages project, collaborating and partnering with all internal/external staff including sponsoring agencies, organizations and/or other research and/or educational institutions to ensure project objectives and timelines are attained. Advises project staff on enhancements and changes to processes, practices, and procedures to ensure compliance with protocols and to increase effectiveness and efficiency of project.
Manages day-to-day project operational and business functions; implements existing policy and ensures the effective, compliant, and efficient completion of daily administrative operations.
Manages lab/study budget and inventory including purchasing of supplies and services ensuring that they are necessary, reasonable and project related.
Orders and maintains inventory of study supplies.
Ensures appropriate and timely compliance with associated local, state, and federal regulatory guidelines, requirements, and laws; and research protocols.
Minimum Qualifications: (Education and experience)
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 2 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 1 year research study or other relevant experience.
Supervisory or project management experience required.
Must complete Northwestern’s IRB CITI training before interacting with any participants and must recertify every 3 years.
Minimum Competencies: (Education and experience)
Attention to detail
Outstanding communication skills
Ability to interact with various patient populations and/or medical conditions
Preferred Qualifications: (Education and experience)
At least 1 year of clinical research experience; working with interventional clinical studies
IATA and CPR certified
Previous experience with working with Pharmaceutical Companies
Preferred Competencies: (Skills, knowledge, and abilities)
Experience with regulatory submissions
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: 34901
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.