22 часа назад
Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions) – UK Remote
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
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Описание вакансии
Текст:
TL;DR
Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions) – UK Remote (Clinical Research): Supporting UK clinical trial start-up and site activation through submission document collection, regulatory package preparation, site document review, and Informed Consent Form adaptations with an accent on regulatory compliance and submission quality. Focus on coordinating investigative sites, resolving outstanding documentation, maintaining study tracking records, and preparing packages for Regulatory Green Light readiness.
Location: United Kingdom (Home-Based); the role requires being based in the UK.
Contract type: Freelance
FTE: 1.0
Start: Immediate
Duration: Approximately 3–6 months
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Collect, review, and prepare site and regulatory documentation for UK clinical trial submissions.
- Support the preparation and submission of regulatory packages in line with study requirements and local regulations.
- Coordinate Informed Consent Form adaptations and associated document updates.
- Review essential site documentation for Regulatory Green Light readiness.
- Liaise with investigative sites to obtain, track, and resolve outstanding documentation.
- Maintain study tracking systems, timelines, and submission records while monitoring site activation milestones.
Requirements
- Based in the United Kingdom.
- 2–3 years of experience in Site Activation, Study Start-Up, Regulatory Affairs, or Clinical Research.
- Strong experience with site document collection, review, and submission preparation.
- Experience supporting clinical trial regulatory submissions in the UK and performing ICF adaptations.
- Understanding of site activation and study start-up processes, with strong attention to detail and timeline management.
- Bachelor’s degree in Life Sciences or a related field; fluent English communication skills required.
Culture & Benefits
- Home-based freelance engagement.
- Collaboration with Site Activation Managers, Regulatory Affairs, Project Management, and other cross-functional teams.
- Work aligned with ICH-GCP, UK regulations, and study-specific requirements.
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