Clinical Research Regulatory Specialist

📋 Description

• Coordinate study startup activities, including IRB submissions, regulatory documentation, vendor
• Support the administration of the Florence eRegulatory platform by creating electronic study
• Prepare, review, and maintain essential regulatory documents, including Financial Disclosure Forms
• Distribute regulatory documents to investigators and research staff for review and signatures
• Submit completed regulatory documentation and investigator credentials to sponsors and CROs within
• Create and maintain delegation of authority logs and training logs, ensuring accuracy throughout

🎯 Requirements

• High school diploma or equivalent required; a bachelor's degree is preferred.
• 1-2 years of clinical research experience, preferably with a focus on regulatory affairs
• Current Good Clinical Practice (GCP) certification.
• Relevant professional licenses or certifications, including continuing education units (CEUs)
• Sound understanding of medical terminology and clinical research processes.
• Working knowledge of ICH/GCP guidelines, applicable regulatory requirements, FDA regulations, and

🎁 Benefits

• Remote Work: Opportunity to work remotely from within the United States.
• Professional Development: Opportunities to expand clinical research regulatory knowledge and
• Meaningful Impact: Contribute to clinical research initiatives focused on bringing innovative
• Collaborative Work Environment: Join a supportive, team-oriented workplace that values
• Career Growth: Opportunities to strengthen your professional skills and pursue long-term
• Purpose-Driven Culture: Work in an environment that prioritizes people, patient communities