Clinical Research Regulatory Coordinator

Job Description
Job Description:
Insight Global is seeking a Clinical Research Regulatory Coordinator for a leading academic healthcare organization. This individual will be responsible for overseeing regulatory compliance across clinical research studies, including managing IRB submissions, maintaining regulatory binders and essential documentation, and supporting study startup through closeout. This role requires experience handling clinical trial documents such as protocols, ICFs, Investigator Brochures, FDA forms, and delegation logs, while managing multiple study timelines in a fast-paced, often multi-study or multi-site environment. The coordinator will work closely with investigators, research teams, sponsors, and CROs to ensure all regulatory requirements are met, support audits and inspections, and contribute to CAPA development and resolution. This position also plays a key role in training and supporting research staff, leveraging strong communication and technical wri...