Regulatory Coordinator
Regulatory Coordinator
Job ID: 42170
Location: Chicago, Illinois
Department: MED-NU-CATS Institute
Salary/Grade: EXS/5
Job Summary:
The Regulatory Coordinator position provides regulatory guidance and support for specific active research studies for the Center for Clinical Research within the NU Clinical and Translational Sciences Institute (NUCATS). The Regulatory Coordinator position coordinates and guides the review and approval processes of research activities associated with clinical research studies involving human subjects, and helps ensure the protection of their safety, rights, and welfare. Main role responsibilities include advising on, interpreting and applying rules and regulations (NU, local, state, federal, industry, sponsor, etc.), submitting and with recommending and guiding principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc., of study activities ensuring appropriate compliance.
The Regulatory Coordinator collaborates with the daily operations of the research study teams (NU biomedical &/or social-behavioral research studies) which can include multidisciplinary teams of colleagues, sponsors & other external project stakeholders. The role helps ensures that all study activities are completed in accordance with the Good Clinical Practice (GCP) & current local, state, & federal laws, regulations, guidance, policies & 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). This position has frequent interaction with physicians, sponsor contacts, Institutional Review Board staff, and study staff members, and interpersonal communication, strong writing skills, and organizational skills are necessary to being successful in this position.
The NUCATS Institutes mission is to catalyze, accelerate, and disseminate innovative and inclusive clinical and translational research to improve human health for all, and for all communities. The Institute is committed to advancing and advocating for diversity, equity, inclusion, and belongingness in our clinical research objectives, research participant recruitment, and research experience as well as in our workforce and workplace.
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 (NUs 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 to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.
Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.
Miscellaneous
Performs other duties as assigned.
Minimum Qualifications:
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience.
General knowledge of protocol design.
Minimum Competencies: (Skills, knowledge, and abilities.)
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
RER Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines.
COMP Computer literacy in word processing database use, and file management.
TEAMPLA Ability to work as part of a team
Preferred Qualifications:
CITI certification
One year experience in research, clinical trials research, or regulatory knowledge
Please apply online at https://careers.northwestern.edu/psp/hr857prd_er/EMPLOYEE/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=1&JobOpeningId=42170&PostingSeq=1
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