Responsibilities
- Assemble and submit regulatory paperwork to institutional review boards and ethics committees
- Assist with initiating clinical studies, including coordinating vendor access and gathering required regulatory materials
- Develop and organize documentation for site selection, preparatory, and initiation visits
- Conduct data input, document refinement, and quality checks during system transitions
- Set up and manage electronic Investigator Site Files using Florence software
- Ensure regulatory documents are properly stored and prepared for audits
- Complete regulatory forms such as FDA Form 1572, Financial Disclosure Forms, Protocol Signature Pages, and Investigational Brochure acknowledgments
- Coordinate document routing for signatures and track completion
- Keep investigator curricula vitae, licenses, and Good Clinical Practice certifications current
- Collaborate with site coordinators, principal investigators, and sponsor teams
- Monitor project timelines and take initiative to address scheduling obstacles
Benefits
- Remote-flexible work setup with adaptable scheduling
- Potential to transition into a permanent position with broader duties
- Engagement with international clinical trial processes and digital tools
- Direct experience using industry-leading eRegulatory systems like Florence
- Dynamic, collaborative, and fast-evolving work culture
- Access to continuous learning and career advancement programs
Work Arrangement
remote-friendly
Team
collaborative, high-growth, entrepreneurial
