Regulatory Coordinator

Department: MED-Clinical Trials Unit
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 Bluhm Cardiovascular Institute Clinical Trials Unit staff members. Interpersonal communication skills along with strong writing skills and organization are necessary for successful performance.

Target hiring range for this position will be between $51,346 - $64,473 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.

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.
• Addresses associated budgetary development with management support
• 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.
• Contribute to the development of the Regulatory Program

Miscellaneous

Performed other duties

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.

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: (Education and experience)

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

Preferred Competencies: (Skills, knowledge, and abilities)

• Cardiovascular experience

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! 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.