Manages daily operations of a biomedical &/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. Monitors study performance, analyzes & review results, & supervises development & implementation of new protocols. Assigns work & supervises study staff & reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. Develops implements & administers budgets, grant & administrative procedures. 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).
Under general direction of the Cancer Center’s Dirctor of clinical research, this position is responsible for administration of the Lurie Cancer Center Scientific Review Committee (SRC), and Disease Team administration. As such, this person coordinates all activities associated with the Scientific Review Committee, and Disease Team protocol review. This position is responsible for processing all cancer-relevant research conducted by NU and NU affiliate institutions, ensuring that the National Cancer Institute regulations are followed regarding Comprehensive Cancer Center designation. Additionally, this position coordinates administrative processes and prioritizes, directs, and responds to business matters involving administrative functions associated with Disease Team research and/or operations. Creates and maintains associated documents, spreadsheets, databases, meetings, special events, etc. and alerts supervisor of critical issues and upcoming events.
Leads execution & control of a biomedical &/or social science project or research study.
Coordinates processing & analysis of data, conduct of experimental tests & procedures
Ensures completion of study activities per protocol including recruitment.
Responsible for the management of the protocol review process including review all new and revised protocols for scientific merit and ongoing progress monitoring.
Collects data from medical records.
Oversees & manages collection, maintenance, analysis & evaluation of data that will be used in grant submissions, presentations & publications.
Ensures that information is entered correctly into databases.
Assists PI in reviewing, analyzing, interpreting, summarizing, formatting, editing, & preparing tables, charts, graphs, progress & final reports, etc.
Coordinates 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.
Ensure all new studies are processed and registered in NOTIS, perform preliminary review of protocols and/or revisions and ensure all associated documents are submitted, assess each protocol and determine appropriate level of reviews, assign reviewers, prepare and distribute protocol materials for review. This regularly involves educating PIs and coordinators of processes and NCI requirements.
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 3 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 & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Ability to establish and maintain effective working relationships with physicians, nurses, co-workers and external contacts.
Excellent verbal and written communication.
Good computer skills, particularly with MS Office.
Detail-oriented and excellent organizational skills.
Previous experience with protocol review and/or development.
Prior experience working with oncology protocols.
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: 39707
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.