Regulatory Coordinator

Job Summary Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research, and family-friendly design. As the largest pediatric provider in the region with a 140‑year legacy of excellence, kids and their families are at the center of all we do. Responsibilities Determine and interpret applicable rules and regulations for complex clinical research studies and trials involving human subjects to protect safety, rights, and welfare. Collaborate with the Office of Research Integrity and Compliance and Corporate Compliance to ensure ongoing compliance. Guide and coordinate all clinical trials–related submissions, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close‑outs, etc.), recommending alternatives to ensure compliance and approval. Submit documents to the IRB and other internal/external regulatory and oversight groups and address any questions or concerns. Act as liaison between affiliate institutions, study sponsors, study coordinators, investigators, and oversight/regulatory agencies when questions, issues, or problems arise regarding study status and process. Serve as a resource to the clinical research office staff on regulatory concepts. Research new and updated rules and regulations related to clinical research studies and trials involving human subjects. Provide guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations. Create and ensure the submission of appropriate documents for new projects, amendments, adverse events, informed consent, revisions, etc. to the IRB and other oversight groups. Determine compliance‑required documentation and draft necessary items such as protocols and informed consent. Ensure accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers. Alert staff to changes and ensure appropriate interpretation and application to new and existing studies and trials. Create reports, summaries, and analyses regarding compliance requirements, recommending changes in practice or procedure to increase effectiveness and efficiency of compliance. Assist the Division Administrator and/or Clinical Research Manager in maintaining the department’s research compliance program by ensuring adherence to institutional policies and procedures, federal, state, and other funding agency rules. Provide guidance and training to investigators and research support staff on applicable rules and regulations. Other job functions as assigned. Qualifications Bachelor’s degree or equivalent and at least three years of experience in a regulatory and/or research environment with strong knowledge of clinical research protocols. Detailed knowledge of federal, state, and local regulations and ethical principles regarding protection of human subjects in research. Working knowledge of local and federal regulations for human subject research (ICH‑GCP, OHRP, FDA regulations). Excellent customer service, project management, and process improvement skills. Ability to take initiative, prioritize tasks to meet deadlines, and cope with inherent pressures. Excellent organizational and analytical skills with sound judgment and problem‑solving ability. Excellent oral and written communication skills; effectively communicates at all levels of the organization; possesses good presentation and training skills. Ability to perform multiple tasks with a high level of accuracy and attention to detail. Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC)). Ability to identify, research, and solve problems. Education Bachelor’s Degree in Risk Management (Required). Pay Range $65,520.00 – $107,120.00. Benefits Medical, dental, and vision insurance. Employer‑paid group term life and disability. Employer contribution toward Health Savings Account. Flexible Spending Accounts. Paid Time Off (PTO), Paid Holidays, and Paid Parental Leave. 403(b) with a 5% employer match. Various voluntary benefits: Supplemental Life, AD&D and Disability, Critical Illness, Accident and Hospital Indemnity coverage, Tuition assistance, Student loan servicing and support, Adoption benefits, Backup Childcare and Eldercare, Employee Assistance Program, and other behavioral health services and resources. Discount on services at Lurie Children’s facilities. Discount purchasing program. Equal Employment Opportunity Statement Lurie Children’s and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. #J-18808-Ljbffr 10 HOSP Ann & Robert H. Lurie Children's Hospital of Chicago