Clinical Trial Support - Regulatory Affairs Administrator
Core
Regulatory Affairs Administrator supporting the full lifecycle of clinical research involving human participants at a university, ensuring compliance with federal regulations and institutional policies.
Role type
Senior IC regulatory affairs administrator (clinical trials)
Builds
Regulatory submission packets, training programs, and compliance documentation for clinical research projects
Domain
Higher education + clinical research compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory strategy development, clinical trial operations, regulatory document preparation, compliance management, stakeholder collaboration, project management, data management, electronic submission systems, contract and grant management
Preferred skills
FDA commercialization pathways knowledge, IND/IDE/PMA/510(k) documentation, funding agency requirements, HIPAA/FDA/OHRP regulations, biomedical research experience
Technologies
CTMS, RedCap, Maestro, electronic submission systems, word processing, spreadsheets
Responsibilities
Develop and implement regulatory strategies and processes; assist investigators with drafting and editing clinical research protocols and submission packets; manage training and education programs on regulatory requirements; maintain audit-ready files and documentation; track regulatory changes and timelines; support study management, feasibility assessments, and data reporting
Seniority
Senior, hands-on IC
