Study Start Up Clinical Research Associate

• Manage end-to-end study start-up activities for assigned sites, from site selection through to site activation
• Conduct site selection activities and assess site suitability, working directly with Principal Investigators and investigational site teams
• Independently prepare, coordinate, and manage regulatory authority and Ethics Committee/IRB/IEC submissions
• Respond to regulatory and ethics queries and resolve deficiencies
• Coordinate the collection, review, and tracking of essential regulatory documentation, including ICFs, CVs, GCP certificates, financial disclosures, and other site-specific documents
• Maintain study start-up systems, trackers, and country/site TMF documentation
• Partner with sites and internal stakeholders to resolve start-up issues
• Support vendor, contract, and investigator payment activities where required
• Ensure sites are fully prepared for site activation and coordinate a seamless handover to the execution CRA

• Previous experience in clinical trial study start-up, site activation, and regulatory submissions
• Demonstrated experience independently managing end-to-end site start-up activities through site activation
• Proven experience independently preparing and managing regulatory authority and Ethics Committee/IRB/IEC submissions, including responding to regulatory and ethics queries
• Strong knowledge of ICH-GCP, local regulatory requirements, essential regulatory documentation, and TMF requirements
• Strong organisational and stakeholder-management skills, with the ability to manage multiple sites, timelines, and competing priorities independently
• Candidates must be based in either Nairobi or Kisumu, Kenya
• Legal right to work in Kenya

• 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 wellbeing resources
• Learning and development opportunities through structured training and career pathways