Regulatory Coordinator Sr

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: (Education, experience, and any other certifications/clearances)

• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelors or higher degree; OR appropriate combination of education and experience.
• Three years 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: (Skills, knowledge and abilities)

• 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: (Education and experience)

• Masters degree preferred;
• One year or more of experience managing staff;

Preferred Competencies: (Skills, knowledge and abilities)

• 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.