Manages daily operations of a multi-center biomedical 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 from other sites & reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. Tracks enrollment and identifies barriers to enrollment among sites. May help develop website and oversee WebEx meetings. 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).
Leads execution & control of a biomedical &/or social science project or research study.
Coordinates processing & analysis of data, conduct of experimental tests & procedures
Develops new &/or revised research methodologies.
Ensures completion of study activities per protocol including recruitment.
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.
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 NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
Minimum Competencies: (Skills, knowledge, and abilities.)
Excellent time management skills and ability to multi-task and prioritize work
Strong organizational and planning skills
Exceptional written and verbal communication skills
Ability to thrive in a collaborative environment
Identifies and resolves problems in a timely manner
Takes independent actions to complete project-related tasks
Ability to multi-task and independently prioritize projects and issues
Capacity to function autonomously within a non-technical team
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 public health, social sciences or other health-related science; OR appropriate combination of education and experience
3 years' research study or other relevant experience.
Preferred Competencies: (Skills, knowledge, and abilities)
Experience working on multi-site trials and related IRB submissions
Proven ability to improve processes and project quality
High level of knowledge on methods to solve conflicts
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: 37566
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.