Regulatory Coordinator-Center Cancer and Blood Disorders

Regulatory Coordinator

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. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.

Location:

875 N Michigan (John Hancock)

Job Description

The Regulatory Coordinator coordinates the review and approval process for an assigned regulatory portfolio associated with clinical research studies involving human subjects within their research program, ensuring the protection of their safety, rights, and welfare. Studies may be large, nationwide, or moderately complex involving multiple sites, assessments and/or interventions. The regulatory coordinator interprets and applies applicable local, state, federal, sponsor, industry, and institutional regulations and provides guidance to Principal Investigators (PIs) and research staff regarding the creation, submission, and reporting of study activities, ensuring regulatory compliance throughout the study lifecycle.

Essential Job Functions:

• Determines and interprets applicable rules and regulations associated with complex clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare. Collaborates with the Office of Research Integrity and Compliance and Corporate Compliance to ensure ongoing compliance.
• Guides and coordinates all clinical trials-related submissions, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) recommending alternatives to ensure compliance and approval. Submits such documents to the IRB and other internal/external regulatory and oversight groups. Works with these groups to address any questions or concerns.
• Acts as a liaison between affiliate institutions, study sponsors, study coordinators, investigators, and appropriate oversight/regulatory agencies when questions, issues, problems arise regarding study status and process. Serves as a resource to the clinical research office staff on regulatory concepts.
• Tracks and applies new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Ensures submission of appropriate documents associated with new projects, amendments, adverse events, informed consent, etc. to the IRB and other appropriate internal and/or external oversight groups.
• Determines compliance-required documentation and drafts 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 research staff to ensure compliance with complex, highly specialized 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.
• Creates reports, summaries, and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.
• Provides guidance for investigators and research support staff on institutional policies and procedures, federal, state, and other funding agency regulations. Compliance program components include, but are not limited to research safety, effort reporting, and conflict of interest reporting.
• Other job functions as assigned.

Knowledge, Skills and Abilities:

• Bachelor's degree or the equivalent and three years of work experience in a regulatory and/or research environment having developed a strong working knowledge of clinical research protocols required.
• Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. Working…