Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions) – UK Remote
Core
Support clinical trial start-up and site activation activities in the UK, focusing on regulatory submission document collection, preparation, and review.
Role type
Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions)
Builds
Regulatory submission packages for UK clinical trials
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Site document collection and review, Regulatory submission preparation, ICF adaptations, Study start-up process knowledge, Timeline management, Cross-functional collaboration
Preferred skills
Experience with UK regulations, ICH-GCP compliance
Technologies
Study tracking systems
Responsibilities
Collect, review, and prepare site and regulatory documentation for UK clinical trial submissions; Support preparation and submission of regulatory packages; Perform and coordinate Informed Consent Form (ICF) adaptations; Review essential site documentation for Regulatory Green Light readiness; Liaise with investigative sites to obtain and resolve outstanding documentation; Ensure completeness and accuracy of submission packages; Maintain study tracking systems and timelines; Monitor site activation progress against milestones.
Seniority
Mid-level, hands-on IC
