Job Description
Job Title: Regulatory Specialist
Job Description
The Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical Practice (GCP), and Institutional policies. This role serves as a liaison to investigators, collaborating divisions, departments, institutions, the Institutional Review Board (IRB), and external regulatory agencies.
Responsibilities
+ Organize and maintain the regulatory binder, file essential documents, and obtain signatures for delegation logs, training logs, and other essential study documents.
+ Review sponsor templates and site-level Informed Consent Forms (ICF) to ensure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
+ Participate in the regulatory review, preparation, and submission of clinical study documentation such as investigator brochures, Investigational Device Exemptions (IDE), and Investigational New Drug (IND) applications.
+ Ensure tim...
Job Description
The Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical Practice (GCP), and Institutional policies. This role serves as a liaison to investigators, collaborating divisions, departments, institutions, the Institutional Review Board (IRB), and external regulatory agencies.
Responsibilities
+ Organize and maintain the regulatory binder, file essential documents, and obtain signatures for delegation logs, training logs, and other essential study documents.
+ Review sponsor templates and site-level Informed Consent Forms (ICF) to ensure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
+ Participate in the regulatory review, preparation, and submission of clinical study documentation such as investigator brochures, Investigational Device Exemptions (IDE), and Investigational New Drug (IND) applications.
+ Ensure tim...
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