Regulatory Specialist I (13)

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 responsibilitiesAssist in reviewing and extracting required data from protocols and documentation to complete IRB applications, including drafting informed consent formsProcess BioSafety applications alongside IRB applications and ensure proper filing of all electronic documentation in accordance with CTO standardsAct as a liaison between internal and external stakeholders, addressing queries and providing necessary documentation for audits and regulatory complianceRequired qualificationsHigh School Diploma/GED required; xmvmafu Associates degree or higher preferred with relevant experienceMinimum of 2 years of relevant experience for Associates degree holders or 3 years for those with a High School Diploma/GEDThorough knowledge of word processing and database usage is essential