Regulatory Coordinator Sr

Clinical Research Regulatory Specialist

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.

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 relevant experience required.

Minimum Competencies:

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

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.

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.

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.

Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status.