Regulatory Specialist I

To support research activities, the full-time remote Regulatory Specialist I will manage the completion and submission of regulatory documents and reports to ensure compliance with internal policies, IRBs, and federal regulations related to human subjects research. Key responsibilities Assist in reviewing and extracting required data from protocols and documentation to complete IRB applications, including drafting informed consent forms Process BioSafety applications alongside IRB applications and ensure proper filing of all electronic documentation in accordance with CTO standards Act as a liaison between internal and external stakeholders, addressing queries and providing necessary documentation for audits and regulatory compliance Required qualifications High School Diploma/GED required; Associate's degree or higher preferred with relevant experience Minimum of 2 years of relevant experience for Associate's degree holders or 3 years for those with a High School Diploma/GED Thorough knowledge of word processing and database usage is essential