Regulatory Coordinator

• Provide regulatory support for research studies in the Department of Pediatrics
• Review documents, applications, agreements, and reports
• Ensure compliance with internal and external regulatory frameworks, regulations, laws, and standards
• Apply regulatory skills across different types of studies, navigate resources, and identify issues for escalation
• Perform quality checks and potentially train staff
• Develop new team and unit processes, procedures, tools, and training
• Provide guidance to research teams regarding compliance with policies, procedures, and regulations
• Communicate directly with protocol sponsors about regulatory documents and activities
• Maintain complete and accurate regulatory files and records
• Serve as the regulatory contact for human-subjects research studies
• Develop clear and accurate informed consent documents
• Prepare and submit protocol-specific application materials to the Institutional Review Board and scientific review committee

• Effective oral and written communication skills
• Independent problem-solving and analytical skills
• Attention to detail and organization
• Prioritization skills and ability to manage multiple projects
• In-depth understanding of, or willingness and ability to learn, clinical research principles and study and institutional guidelines
• Ability to support investigators and study teams with a service-oriented approach
• Experience with Institutional Review Board submissions or equivalent submissions preferred
• Experience with human subjects research preferred
• Experience with REDCap, ARROW, electronic IRB systems, OnCore, Health Link, Microsoft Office Suite, Adobe Acrobat, and file-sharing systems such as Google Drive or Box preferred
• Bachelor's degree preferred
• Cover letter required
• Resume required
• Continuous eligibility to work in the United States without employer sponsorship
• Ability to provide proof of work authorization and eligibility to work
• Employment may require a criminal background check
• References may be requested from final candidates

Demonstrates expertise in regulatory compliance for human-subjects research, including the preparation and submission of Institutional Review Board applications. Proficient in developing processes and providing guidance to research teams while ensuring adherence to clinical research principles and standards.

• Regulatory Compliance
• Institutional Review Board Submissions
• Human Subjects Research
• REDCap
• Analytical Skills

• Regulatory Support
• Quality Checks
• Document Review
• Informed Consent Development
• Protocol-Specific Applications

• Effective Communication
• Problem-Solving
• Attention to Detail
• Organizational Skills
• Service-Oriented Approach

• Clinical Research Principles
• Regulatory Frameworks
• Compliance Standards
• Research Studies
• Research Teams

• REDCap
• ARROW
• On Core
• Health Link
• Microsoft Office Suite
• Adobe Acrobat
• Google Drive
• Box