Site Specialist I (Regulatory Submissions)
Core
Support investigator sites with administrative and operational activities to ensure clinical trials run smoothly, efficiently, and in compliance with regulations.
Role type
Site Specialist I (Regulatory Submissions)
Builds
Clinical trial site activation and operational support
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Document preparation and tracking, Clinical trial management systems, Site communication, Audit/inspection readiness support, GCP principles, ICH guidelines
Preferred skills
Clinical research experience, Regulated environment experience, Spreadsheets and database management
Responsibilities
Prepare and track site-level critical documents for activation, Maintain site information in clinical trial management systems, Assist with site communications and meeting scheduling, Prepare materials for site visits and audits, Ensure documentation filing for inspection readiness, Collaborate with CRAs to resolve site queries