About the Role
This role involves supporting clinical trial operations through coordination of trial documentation, site management, and adherence to timelines and regulatory standards.
Responsibilities
- Coordinate preparation and review of essential clinical trial documents
- Assist in maintaining trial master files and regulatory binders
- Support site initiation, monitoring, and closeout activities
- Track and manage clinical trial timelines and milestones
- Ensure compliance with SOPs and regulatory requirements
- Collaborate with internal teams to resolve operational issues
- Monitor site performance and support corrective actions
- Maintain accurate and up-to-date trial records
- Participate in vendor and site communications
- Assist in the development of study tools and templates
- Support audit and inspection readiness activities
- Track and report on key operational metrics
- Coordinate investigator payments and site budget tracking
- Facilitate internal team meetings and follow-up actions
- Assist in the review of informed consent forms
- Manage document distribution and tracking systems
- Support protocol and training material development
- Monitor regulatory submissions and approvals
- Ensure data integrity across trial systems
- Assist in risk identification and mitigation planning
- Support cross-functional project teams
- Maintain vendor oversight documentation
- Track trial supplies and site needs
- Participate in study-specific training
- Ensure adherence to quality standards
Compensation
Not specified
Work Arrangement
Remote
Team
Cross-functional clinical operations team
Why Consider This Role?
- Opportunity to work remotely within a global clinical development environment
- Exposure to diverse therapeutic areas and complex trial designs
Career Development
- Access to training programs and professional growth resources
- Mentorship and performance feedback opportunities
Not available
