Study Start-Up Clinical Research Associate

About the role

ICON Strategic Solutions is hiring a Study Start-Up Clinical Research Associate to work in a sponsor-dedicated model, supporting the activation of clinical trial sites. The role covers site selection through site activation, ensuring sites are activated efficiently and in line with ICH-GCP, local regulatory requirements and applicable SOPs. Candidates must be based in Nairobi or Kisumu, Kenya.

Key responsibilities

• Take ownership of end-to-end study start-up for assigned sites, from site selection to activation, and act as a key point of contact for investigational sites
• Conduct site selection and assess site suitability, working with Principal Investigators and site teams
• Prepare, coordinate and manage regulatory authority and Ethics Committee/IRB/IEC submissions, including queries and deficiencies
• Collect, review and track regulatory documents such as ICFs, CVs, GCP certificates and financial disclosures
• Maintain study start-up systems, trackers and country/site TMF documentation so it is complete, accurate and inspection-ready
• Resolve start-up issues proactively, support vendor, contract and investigator payments where needed, and ensure a smooth handover to the execution CRA

Required profile

• Previous experience in clinical trial study start-up, site activation and regulatory submissions
• Ability to independently manage end-to-end site start-up and regulatory submissions
• Experience managing multiple sites, timelines and competing priorities independently
• Legal right to work in Kenya

Required skills

• ICH-GCP and local regulatory requirements
• Regulatory authority and ethics committee submissions
• TMF documentation

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities