Job Description
Job Title: Regulatory Specialist
The Regulatory Specialist promotes compliance with federal regulations, Good Clinical Practice (GCP), and institutional policies for clinical trials. This role serves as a key liaison among investigators, internal departments, institutional review boards (IRBs), and external regulatory agencies to support the safe and compliant conduct of clinical research. The position focuses on managing regulatory documentation, facilitating IRB submissions, and ensuring that all regulatory requirements for clinical studies are met in a timely and accurate manner.
Responsibilities
+ Organize and maintain regulatory binders, including filing essential documents and obtaining required signatures for delegation logs, training logs, and other critical study records.
+ Review sponsor template and site-level informed consent forms (ICFs) to ensure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
+ Partici...
The Regulatory Specialist promotes compliance with federal regulations, Good Clinical Practice (GCP), and institutional policies for clinical trials. This role serves as a key liaison among investigators, internal departments, institutional review boards (IRBs), and external regulatory agencies to support the safe and compliant conduct of clinical research. The position focuses on managing regulatory documentation, facilitating IRB submissions, and ensuring that all regulatory requirements for clinical studies are met in a timely and accurate manner.
Responsibilities
+ Organize and maintain regulatory binders, including filing essential documents and obtaining required signatures for delegation logs, training logs, and other critical study records.
+ Review sponsor template and site-level informed consent forms (ICFs) to ensure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
+ Partici...