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

Job Description:

  • Collect, review, and prepare site and regulatory documentation required for UK clinical trial submissions
  • Support the preparation and submission of regulatory packages in accordance with study requirements and local regulations
  • Perform and coordinate Informed Consent Form (ICF) adaptations and associated document updates
  • Review essential site documentation to support Regulatory Green Light readiness
  • Liaise directly with investigative sites to obtain, track, and resolve outstanding documentation
  • Ensure the completeness, accuracy, and quality of submission packages
  • Maintain study tracking systems, timelines, and submission records
  • Support site activation activities and monitor progress against project milestones
  • Collaborate closely with Site Activation Managers, Regulatory Affairs, Project Management, and other cross-functional teams
  • Ensure compliance with ICH-GCP, local UK regulations, and study-specific requirements

Requirements:

  • Based in the United Kingdom
  • Minimum 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
  • Experience performing ICF adaptations
  • Solid understanding of site activation and study start-up processes
  • Strong attention to detail and ability to manage multiple priorities and timelines
  • Bachelor's degree in Life Sciences or a related field
  • Fluent English communication skills, both written and verbal

Benefits:

  • Freelance contract
  • Full-time equivalent (FTE 1.0)
  • Home-based work in the United Kingdom
  • Immediate start
  • Approximately 3–6 month engagement
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