Senior Regulatory Coordinator, Canning Thoracic Institute (CTI), Full-Time, Days

The salary range for this position is $41.36 - $53.77 (Hourly Rate). Placement within the salary range is dependent on several factors such as relevant work experience and internal equity. For positions represented by a labor union, placement within the salary range is guided by the rules outlined in the collective bargaining agreement. Benefits

• 10,000 Tuition Reimbursement per year ($5,700 part‑time)
• 10,000 Student Loan Repayment ($5,000 part‑time)
• 1,000 Professional Development per year ($500 part‑time)
• 250 Wellbeing Fund per year ($125 for part‑time)

Matching 401(k) Excellent medical, dental and vision coverage Life insurance Annual Employee Salary Increase and Incentive Bonus Paid time off and Holiday pay Job Description The Senior Regulatory Coordinator reflects the mission, vision, and values of NMHC, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards. Under the direction of the Stem Cell Transplant and Cell Therapy – Autoimmune Diseases Program Manager, the position will be responsible for all regulatory matters concerning the protection of human subjects for studies conducted in the Program. 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 with little need for guidance from investigators and/or Research Team Members; may prepare submissions to NU Research Ancillary Departments, 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 the process of submissions in eIRB; provides guidance on form preparation and submission and informs Research staff of critical process and policy issues. Interprets existing and/or new regulatory requirements, developments and Institutional Regulatory Policies as they relate to human subject research; maintains current knowledge of federal and institutional guidelines; recommends and implements regulatory process improvements. Develops and manages the internal monitoring and 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, including e-regulatory compliance 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. Performs other duties assigned. Required 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 years 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. Preferred Qualifications Master’s degree preferred. Knowledge of or experience in NIH grant writing, applications, administration. Experience working in oncology and/or familiarity with treatments such as stem cell transplant and/or cellular therapies. Equal Opportunity Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status. Background Check Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check. Results are evaluated on a case‑by‑case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act. #J-18808-Ljbffr Northwestern Memorial Hospital