Regulatory Coordinator

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 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 with 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 analyses 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

Perform other duties as assigned

Minimum Qualifications: (Education, experience, and any other certifications or clearances)

• 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.)

• Attention to Detail - Consistently displays accuracy and attention to detail.
• 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.
• Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines.
• Computer literacy in word processing database use and file management.
• Ability to work as part of a team.

Preferred Qualifications: (Education and experience)

• CITI certification
• One year experience in research, clinical trials research, or regulatory knowledge

Preferred Competencies: (Skills, knowledge, and abilities)

• Knowledge of Institutional Review Board (IRB) submission process of new studies, maintenance and continuing renewals
• Ability to independently create and maintain regulatory documentation including but not limited to informed consent, FDA 1572, Financial Disclosure Form (FDF), Delegation of Authority Log (DOA), etc.
• Strong oral and written communication; Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters using appropriate vocabulary and grammar.

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. For a comprehensive overview of available benefits, including eligibility details, visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

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