at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 54029
Department: MED-NU-CATS Institute
Salary/Grade: EXS/5
Target hiring range for this position will be between $57,000 - $66,734 per year. Offered salary will be determined by the applicant’s education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.
Job Summary:
The Northwestern University Clinical and Translational Sciences (NUCATS) Institute is part of the Feinberg School of Medicine. NUCATS’ mission is to accelerate innovative and inclusive clinical research discoveries to improve human health for all, and for all communities. Our dynamic team is composed of faculty and staff colleagues with expertise in a wide variety of domains, including: clinical research infrastructure (e.g., regulatory, budget/finance), bioinformatics & data science, biostatistics, community-engaged research, education & career development, team science, etc.
This position – Regulatory Coordinator – is part of the NUCATS Institute’s Center for Clinical Research. This position will interact with physician investigators, study staff members, and NUCATS staff members. Strong interpersonal communication skills along with strong writing skills and organization are necessary to being successful in this position.
The Regulatory Coordinator position coordinates and guides the review and approval process of all research activities associated with clinical research studies involving human subjects, ensuring the protection of their safety, rights, and welfare. This position interprets and applies rules and regulations (NU, local, state, federal, sponsor, etc.) and recommends and guides principal investigators (PIs) and clinical research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance.
The Regulatory Coordinator collaborates with daily operations of biomedical &/or social-behavioral research studies involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. The Regulatory Coordinator ensures that all study activities are completed by strictly following Good Clinical Practice (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
The NUCATS Institute is committed to maintaining a culture that values and prioritizes professional growth and work-life balance and to sustaining a diverse, inclusive, and welcoming environment for all team members.
Specific Responsibilities:
- Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects, ensuring the protection of their safety, rights, and welfare. Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety repo
