Freelance Site Activation Specialist – Study Start-Up, Regulatory Submissions

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Gather, assess, and compile the necessary site and regulatory documentation for UK clinical trial submissions.

• Assist in the preparation and submission of regulatory packages in line with study requirements and local regulations.

• Execute and coordinate modifications to Informed Consent Forms (ICF) and related document updates.

• Review critical site documentation to ensure readiness for Regulatory Green Light.

• Communicate directly with investigative sites to obtain, monitor, and resolve any outstanding documentation issues.

• Guarantee the completeness, accuracy, and quality of submission packages.

• Maintain study tracking systems, timelines, and documentation records.

• Assist with site activation activities and track progress against project milestones.

• Work collaboratively with Site Activation Managers, Regulatory Affairs, Project Management, and other cross-functional teams.

• Ensure adherence to ICH-GCP, local UK regulations, and study-specific requirements.

⛳️ Requirements

• Located in the United Kingdom.

• At least 2–3 years of experience in Site Activation, Study Start-Up, Regulatory Affairs, or Clinical Research.

• Strong background in site document collection, review, and submission preparation.

• Experience in supporting clinical trial regulatory submissions in the UK.

• Proficient in performing ICF adaptations.

• Comprehensive understanding of site activation and study start-up processes.

• Excellent attention to detail with the ability to handle multiple priorities and timelines.

• Bachelor's degree in Life Sciences or a related discipline.

• Proficient in English communication skills, both written and spoken.

🏝️ Benefits

• Freelance contract.

• Full-time equivalent (FTE 1.0).

• Remote work based in the United Kingdom.

• Immediate start available.

• Engagement lasting approximately 3–6 months.