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Clinical Research Regulatory Specialist
A company is looking for a Clinical Research Regulatory Specialist. Key Responsibilities Prepares and maintains regulatory binders for audits and reviews Maintains required regulatory documentation for studies and sponsors Submits Adverse Event Reports and Protocol Deviations in compliance with requirements Required Qualifications Bachelor's degree 3 years of relevant experience Basic understanding of FDA and OHRP regulations and ICH guidelines Experience with regulatory processing and submissions Adept at learning new technologies
A company is looking for a Clinical Research Regulatory Specialist.
Key Responsibilities
Prepares and maintains regulatory binders for audits and reviews
Maintains required regulatory documentation for studies and sponsors
Submits Adverse Event Reports and Protocol Deviations in compliance with requirements
Required Qualifications
Bachelor's degree
3 years of relevant experience
Basic understanding of FDA and OHRP regulations and ICH guidelines
Experience with regulatory processing and submissions
Adept at learning new technologies