Regulatory Specialist I
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Job Summary
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
Complete Job Description
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