Regulatory Coordinator Sr

Department: MED-Clinical Trials Unit
Salary/Grade: EXS/7

Target hiring range for this position will be between $63,079 - $80,106 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:

Under the direction of the Bluhm Cardiovascular Institute Clinical Trials Unit (CTU) Research Program Development Director 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. This position oversees the submission process to the Institutional Review Board (IRB) of new studies being processed through the CTU, with a particular focus on highly complex protocols involving more than minimal risk to research subjects. The submission process includes completion of extensive, detailed forms summarizing all aspects of a research study as well as the development of new research subject consent forms. This is made possible by the Senior Regulatory Coordinator's ability to read and interpret highly specialized research protocols, by negotiating with study sponsors and through understanding of federal regulations governing medical research. Usually acting on behalf of Principal Investigators, this position will be responsible for subsequently addressing IRB concerns, questions and requests regarding any aspect of a clinical research study until approval is received. This position will serve as the prime contact liaison between the Principal Investigators, sponsor companies, and the IRB. This position will manage the development of regulatory operating policies and procedures for the Clinical Research core. This position will provide expertise to Investigators on regulatory policies guidelines, compliance reporting, and submissions.

This position has a hybrid work arrangement and has some required on-site activities. Applicants must be authorized to work for ANY employer in the U.S. We are unable to provide employment sponsorship or take over sponsorship of an employment Visa at this time for this position.

Specific Responsibilities:

• Manages submission of all regulatory documents to the IRB, including development of informed consent forms and protocol review for complex studies involving more than minimal risk to research subjects. Works independently to complete high-acuity protocol reviews with little need or no need for guidance from investigators and/or Clinical Research Associates. May prepare Clinical Research Unit (CRU) applications, IND applications and renewals. Corresponds with the FDA throughout the IND process. Submits study renewal applications and study progress reports to the IRB.
• Trains research staff regarding process of submissions in eIRB. Provides guidance on form preparation and submission and informs Research staff of critical process and policy issues.
• Negotiates study budget with sponsoring agency. Works with NMH Office of Research, NU Office of Sponsored Research and NMG ancillary research personnel to fully develop the internal study budget, and contract for appropriate services.
• Interprets existing and/or new regulatory requirements, developments and Institutional Regulatory Policies as they relate to human subjects research in order to effectively communicate regulatory requirements to the research staff. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Recommends and implements regulatory process improvements.
• Develops and manages the internal monitoring auditing program. Schedules, prepares and participates in all internal and external program audits (monitoring visits), interacts with regulatory agents, and Sponsor monitors. Ensures regulatory binders are well-maintained, organized and complete.
• Communicates with IRB and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions. Monitors study closure activities and coordinates project close-out with study sponsors, investigators and the IRB.

• Tracks study approvals and expirations to ensure uninterrupted project approval. Maintains regulatory database and manages electronic filing of all regulatory documents.

Miscellaneous

Performs 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.
• 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: (Skills, knowledge, and abilities.)

• ATTDET - Attention to Detail Consistently displays accuracy and attention to detail
• COW - Communication-Oral and Written Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar.
• 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
• PRS - Problem Solving Formulates realistic plans and contingencies and establishes appropriate measurements of anticipated results.
• RER - Research Regulations Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
• TEAM PLA - Team Player Seeks to build collaboration by encouraging trust, mutual respect and shared purpose among various participants in an engagement

Preferred Qualifications: (Education and experience)

• Master's degree preferred.
• One year or more of experience managing staff.
• Knowledge of or experience in NIH grant writing, applications, administration.

Preferred Competencies: (Skills, knowledge, and abilities)

• Previous interaction with IRB.
• Clinical experience or knowledge with an emphasis in the cardiovascular area
• Budgeting experience

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.