Clinical Research Regulatory Specialist

Essential Duties and Responsibilities: 

• Prepare, submit, and track IRB applications for new studies, amendments, continuing reviews, and study closures 
• Serve as a regulatory resource for investigators and research staff; assist with regulatory education and SOP adherence
• Facilitate contract and budget administration by coordinating IRB, sponsor organizations, physicians, outside counsel, and internal staff to keep projects on track
• Maintains regulatory binders and essential documents in compliance with FDA, CFR, ICH-GCP, HIPAA, and institutional policies
• Support internal audits, sponsor monitoring visits, and regulatory inspections; maintain audit-ready files
• Assist with data reporting, electronic data entry, and administrative study tasks as required by protocol
• Support quality initiatives and regulatory process improvements in collaboration with the Clinical Research Manager

MINIMUM: 

• Bachelor's degree in health sciences, life sciences, public health, healthcare administration, or related field 
• Two or more years of clinical research experience; preferably with demonstrated regulatory and IRB submission responsibilities

PREFERRED: 

• Five plus years of clinical research regulatory experience 
• Master's degree in related field 
• Professional certifications such as CCRC (ACRP) or CCRP (SOCRA) 
• Experience supporting multi-site or industry-sponsored clinical trials  

Additional required skills include a working knowledge of FDA regulations (e.g. 21 CFR Parts 50, 54, 56, and 312/812 as applicable), the clinical trial process, and ICH-GCP guidelines. This role requires strong organizational skills and a high attention to detail. 

Equal Opportunity Employer/Veterans/Disabled  

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