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).
Please Note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters.
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.
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.
Manages lab/study budget & inventory including purchasing of supplies & services ensuring that they are necessary, reasonable & project related.
Orders & maintains inventory of study supplies.
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.
Prior working experience in electronic submission of IRB protocols, continuing reviews, and closeouts
Preferred Competencies: (Skills, knowledge, and abilities)
Possess, and maintains, current knowledge of all applicable IRB rules, regulations, and related institutional procedures.
Skill/knowledge of EPIC, RedCap, Study Tracker, and eIRB.
Action oriented - Willing or likely to take practical action to deal with a problem or situation.
Coachability - Receptive to feedback, willing to learn, embracing continuous improvement.
Collaboration - Facilitates open and effective communication, cooperation and teamwork within and outside of one's own team.
Collegiality - Helpful, respectful, approachable; builds strong working relationships and a positive work environment.
Initiative - Exhibits energy and desire to achieve; sets ambitious goals and acts decisively; takes action that no one has requested to improve or enhance job results and avoid problems.
Meets deadlines - Displays consistency and success in adhering to deadlines.
Multi-tasking - Demonstrates ability to work on multiple projects simultaneously.
Organization - Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail.
The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.
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. Click for information on EEO is the Law.
Internal Number: 41287
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.