Johns Hopkins All Children's Hospital · 3 weeks ago
Clinical Research Regulatory Coordinator I
Johns Hopkins All Children's Hospital is seeking a Clinical Research Regulatory Coordinator I for Study Activation. This role will be responsible for maintaining regulatory files for pediatric clinical research studies and coordinating submissions to the Institutional Review Board.
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Responsibilities
Ensuring that accurate and up-to-date regulatory files are maintained for all pediatric clinical research studies
Serving as a central resource for faculty conducting interventional and non-interventional clinical and translational research
Coordinating the submission of initial Institutional Review Board (IRB) applications for complex clinical research studies
Preparing all regulatory binders prior to the start of each study, containing IRB-approved initial documents and sections for all required documents
Ensuring that all applicable changes in study design and/or conduct, and all continuing reviews, are submitted to the IRB in a timely manner
Updating the study team on IRB approval status of submitted study changes and continuing reviews
Qualification
Required
Bachelor's degree
2 years of clinical research experience equivalent healthcare experience with knowledge of regulatory and/or study startup process
Associate's degree
6 years of experience in clinical research / equivalent healthcare experience with knowledge of regulatory and/or study startup process
Computer proficiency in using Microsoft Office including Word, Excel, and Outlook
Ability to communicate effectively, both verbally and in writing; ability to read, write, speak and understand English
Excellent organizational and time management skills
Motivated, organized, personable, willing to learn, responsible, reliable, and efficient
Benefits
Career growth and development
Employee and Dependent Tuition Assistance
Diverse and collaborative working environment
Affordable and comprehensive benefits package
Company
Johns Hopkins All Children's Hospital
Johns Hopkins All Children's Hospital is a children's hospital located in St. Petersburg, Florida.
Funding
Current Stage
Late StageLeadership Team
Recent News
2025-11-19
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