at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 49883
Department: MED-Cancer Center
Salary/Grade: EXS/5
Job Summary:
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. 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.
Please describe clinical research studies: Cancer-relevant clinical and research studies involving human subjects.
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 reports, close-out, etc.) recommending alternatives to ensure compliance and approval.
- Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU’s IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance.
- Determines compliance required documentation and drafts necessary items such as protocols, informed consent, etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.
- Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.
- Creates reports, summaries and analysis in regard t
