Regulatory Coordinator

Job Responsibilities

• 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.
• Sets up and submits such documents to the IRB and other internal/external regulatory and oversight groups.
• Works with these groups to address any questions or concerns.
• Serves 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.
• Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects.
• 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.
• Aids the Division Administrator and/or Clinical Research Manager in maintaining department’s research compliance program by ensuring adherence to all institutional policies and procedures, federal, state, and other funding agency rules and regulations.
• Provides guidance and training to investigators and research support staff on applicable rules and regulations.

Qualifications

• 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 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, produce results and cope with the inherent pressures.
• Excellent organizational and analytical skills: ability to apply sound judgment and take initiative in collection of information from a wide variety of sources; ability to identify and resolve issues.
• Excellent oral and written communication skills; effectively communicates with all levels of the organization; 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.