With daily guidance and direction, assists with completing clerical and administrative tasks in support of unit’s sponsored program and research mission. Coordinates with regulatory staff to assist with completing documents for regulatory preparation for research. Provides administrative support for all functions of the department. Assists in the preparation of material for inclusion in reports. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedures developed by the NU Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
Maintains detailed records which may include collecting, exacting & entering date; &/or preparing spreadsheets
Creates regulatory binders according to standard procedures/instructions
Files documents in regulatory binders daily; includes travel to various buildings on Northwestern University’s Feinberg School of Medicine Campus
Assists the Regulatory staff with projects as needed
Assists with minimal complexity IRB submissions under guidance
Follows instructional documents to complete tasks thoroughly and accurately
Reports regulatory activity to the study team at weekly meetings
Maintains timely, accurate records related to regulatory activities
Performs other duties as assigned
Northwestern University seeks to employ a varied and diverse range of dynamic people who understand the importance of our mission and vision. When you consider a temporary opportunity at Northwestern University, you know that you are joining an institution with a deep history of academic, professional and personal development.
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: 41233
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.