Regulatory Coordinator Sr

Northwestern University; Chicago (IL); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Tuition benefits

Flexible work arrangements

Paid leave

Job summary

Northwestern University’s Comprehensive Transplant Center seeks an experienced Regulatory Affairs Specialist to manage regulatory oversight for studies involving human subjects. The role coordinates review and approval processes for complex clinical research across sites, ensuring participant safety, rights, and welfare, while guiding investigators on applicable rules and documentation.

The position requires interpreting CFRs and GCP guidelines, providing senior staff guidance, and training

Qualifications

• Bachelor's degree or higher required.
• Minimum of three years of experience in regulatory/medical research environment.
• Familiarity with CFRs and Good Clinical Practice guidelines.

Responsibilities

• Determines and interprets applicable rules and regulations for clinical studies involving human subjects.
• Guides submission, documentation, and reporting processes (new study applications, renewals, amendments, adverse events).
• Acts as liaison between PI, staff, and regulatory bodies (IRB, NIH, FDA, sponsors).
• Assists junior staff in resolving issues and ensuring compliance.
• Ensures accuracy of IRB approval letters and sponsor information.
• Provides training on complex regulatory requirements for clinical research.

Skills

Regulatory knowledge

Communication skills

Computer literacy

Team collaboration

Education

Bachelor's degree or higher

Job description

Location: Chicago, Illinois

Department: MED-Transplant Center

Salary/Grade: EXS/7

Target hiring range for this position will be between $70,000 - $85,000. 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

Under the direction of the Comprehensive Transplant Center's Director of Clinical Research and the Administrative Director, the position will be responsible for all regulatory matters concerning the protection of human subjects for studies conducted in the Clinical Research core. Coordinates and guides the review and approval process of all research activities associated with complex clinical research studies involving human subjects ensuring the protection of their safety, rights, and welfare. These studies are considered complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets. 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. Provides training and guidance to junior staff.

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.) some of which may be very complex in nature, 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.
• Assists junior staff in resolving such issues and problems.
• Determines compliance required documentation and develops 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 junior staff and 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.
• Serves as a resource to the clinical research office staff on regulatory concepts.

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.
• Three year's of work experience in a regulatory and/or medical research environment having developed a strong working knowledge of clinical research protocols or other relavant experience required.

Minimum Competencies

• RER - Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice guidelines.
• COW - Strong communication, writing, and interpersonal skills.
• COMP - Computer literacy in word processing, database use, and file management.
• TEAM PLA - Ability to work as part of a team

Preferred Qualifications

• Master's degree preferred;
• One year or more of experience managing staff;

Preferred Competencies

• Previous interaction with IRB.
• One year of work experience in a regulatory and or medical research environment having developed a strong working knowledge of clinical research protocols.

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.