Base: $30.70 - $46.05; bonus/equity: not specified...
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Fda and dhhs regulations
Ich gcp guidelines
Human subject protection rules
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Wake Forest University Health Sciences is seeking a fully remote Research Regulatory Specialist to support complex clinical research studies by preparing regulatory documents, ensuring compliance with various regulations, and collaborating with study teams. The position requires a Bachelor's degree and typically three years of relevant experience, focusing on regulatory knowledge in clinical trials. The role offers competitive compensation and a comprehensive benefits package.
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Job Summary
Supports multiple complex clinical research studies, including multi-centered, cooperative group, single site, intergroup, industry, and investigator-initiated studies.
Plans, develops, and prepares all required regulatory documents for submissions to IRB, FDA, OHRP, and other regulatory bodies.
Advocate Health offers a comprehensive suite of Total Rewards, including competitive compensation, generous retirement offerings, and programs that invest in your career development.
Matching Summary
Match Score: 75
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Wake Forest University Health Sciences is seeking a fully remote Research Regulatory Specialist to support complex clinical research studies by preparing regulatory documents, ensuring compliance with various regulations, and collaborating with study teams. The position requires a Bachelor's degree and typically three years of relevant experience, focusing on regulatory knowledge in clinical trials. The role offers competitive compensation and a comprehensive benefits package.
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Salary
Base: $30.70 - $46.05; Bonus/Equity: Not specified; Benefits: Eligible
Skills & Requirements
Must-have
FDA and DHHS regulations
ICH GCP guidelines
Human Subject Protection rules
regulatory documents
clinical trials terminology
Microsoft Office Suite
Nice-to-have
quality improvement activities
quality assurance activities
work under pressure
work independently
high degree of accuracy
Key Requirements
3 years of experience
Bachelor's Degree in Business or related field
Bachelor's Degree in Health Care Administration or related field