Regulatory Coordinator

Research Regulatory Coordinator

This position will assist with the submission process to the Institutional Review Board (IRB) of new studies, revisions, and renewals being processed through the department and will serve as a contact liaison for regulatory matters among the research staff and Principal Investigators, sponsor companies and the IRB. Interprets and applies rules and regulations (NU, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance. The department conducts a wide variety of clinical research including drug trials, biological sample studies, interventional studies, and retroactive and prospective data studies. Studies are funded by the NIH, industry and foundations.

Specific Responsibilities:

• Assists PI's in gaining Institutional Review Board (IRB) approval for new research protocols involving less than minimal risk to research subjects, i.e. retrospective and prospective medical record reviews by submitting new study applications through the eIRB system.
• Assists in the preparation and tracking of IRB submissions including annual renewals, revisions and safety reports as needed for principal investigators and research coordinators for transplant research studies.
• Completes IRB requests for modifications as needed.
• Supports regulatory activities related to multiple clinical research projects under the direction of clinical research nurses.
• Works as a liaison between research staff and the IRB.
• Serves as contact between sponsor, PI and IRB.
• Communicates with collaborating faculty both inside and outside the University.
• Assists research staff in formatting study protocol using transplant research template.
• Assists manager in the drafting of informed consents and coordinates gaining IRB approval.
• Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.
• Works with research staff and study sponsors to maintain research binders and documentation to ensure studies are in compliance with applicable regulations.
• Supports data management and the maintenance of study records and databases.
• Aids clinical research nurses in preparing final reports for close-out submissions.
• Provides assistance with submission of IND applications and renewals with the FDA as needed.
• Corresponds with the FDA throughout the IND process.
• Miscellaneous Performed other duties

Minimum Qualifications:

• Bachelor's degree knowledge or equivalent combination of experience or education from which comparable skills may be acquired.
• Minimum Competencies: ATTDET Attention to Detail Consistently displays accuracy and attention to detail ORG Organization Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources

Preferred Qualifications:

• CITI certification
• One year experience in research, clinical trials research, or regulatory knowledge
• At least one year of experience supporting clinical trials with hands-on responsibility for IRB submissions, correspondence, and compliance activities

Preferred Competencies:

• COW Communication-Oral and Written Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar.
• RER Research Regulations Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
• TEAM PLA Team Player Seeks to build collaboration by encouraging trust, mutual respect and shared purpose among various participants in an engagement.

Benefits: At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs.