Research Regulatory Specialist - NCCT; Remote

Overview

Employer Industry: Healthcare Research

Why consider this job opportunity:

• Salary up to $46.05 per hour
• Opportunity for annual increases based on performance
• Comprehensive benefits package, including medical, dental, vision, and retirement plans with employer match
• Paid Time Off programs and family benefits such as adoption assistance and paid parental leave
• Engaging work environment with opportunities for career development and growth
• Flexibility to work remotely within designated hours

• Support multiple complex clinical research studies, including multi-centered and single-site studies
• Prepare and submit all required regulatory documents to IRB, FDA, and other regulatory bodies
• Collaborate with research teams to ensure compliance with safety and protocol changes
• Maintain study documentation and ensure files are audit-ready
• Provide guidance and training to research staff on compliance with regulations

• Bachelor's Degree in Business, Health Care Administration, or a related field
• Minimum of 3 years of experience in research, clinical trials research, and regulatory knowledge
• Strong knowledge of FDA and DHHS regulations, ICH GCP guidelines, and Human Subject Protection rules
• Excellent verbal and written communication, organizational, and time management skills
• Proficiency in Microsoft Office, Word, Excel, Adobe, and Teams

• Experience with clinical trials and terminology
• Strong problem-solving skills and ability to work independently with high accuracy

#Healthcare Research #Clinical Trials #Regulatory Compliance #Career Development #Remote Work Opportunity

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