What is an expanded access program coordinator?

An Expanded Access Program Coordinator is a professional responsible for managing and overseeing expanded access or compassionate use programs, which allow patients with serious or life-threatening conditions to access investigational drugs or treatments outside of clinical trials. They work closely with healthcare providers, regulatory agencies, and pharmaceutical companies to ensure compliance with regulations and to facilitate patient access to potentially life-saving therapies. Their duties often include handling documentation, coordinating applications, and monitoring patient outcomes. This role requires strong organizational skills, knowledge of regulatory requirements, and effective communication with multiple stakeholders.