Regulatory Coordinator

Employer
Northwestern University
Location
Chicago, Illinois
Salary
Commensurate with qualifications
Posted
November 16 2021
Organization Type
Academia

Regulatory Coordinator

Job ID: 41134
Location: Chicago, Illinois

Department: MED-NU-CATS Institute
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.

Collaborates with daily operations of a biomedical &/or social-behavioral research studies involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders.  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). 

This position will interact with physicians, study staff members, and NU Clinical and Translational Sciences (NUCATS) Institute staff members.   Interpersonal communication skills along with strong writing skills and organization are necessary to being successful in this position.

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 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=41134&PostingSeq=1

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.