A leading research organization in Florida is seeking a dedicated Regulatory Specialist/Affair to manage research processes in compliance with regulations. The ideal candidate will have a bachelor's degree with significant experience in clinical trials, including protocol management and regulatory compliance. This role entails drafting protocol documents and maintaining regulatory binders to ensure adherence to sponsor specifications. We welcome applicants with a master's degree and relevant experience in the clinical research field.
Qualifications
8 years experience in clinical trials, 2 years in clinical area.
4 years experience in clinical trials if holding a master's degree.
Responsibilities
Deliver high-level research administration support.
Manage research processes and obligations per regulations.
Draft or edit protocol documents and submit for review.
Maintain regulatory binders and delegation of authority logs.
Education
Bachelor's degree in a related field
Master's degree
Job description
A leading research organization in Florida is seeking a dedicated Regulatory Specialist/Affair to manage research processes in compliance with regulations. The ideal candidate will have a bachelor's degree with significant experience in clinical trials, including protocol management and regulatory compliance. This role entails drafting protocol documents and maintaining regulatory binders to ensure adherence to sponsor specifications. We welcome applicants with a master's degree and relevant experience in the clinical research field.