[Hiring] Study Start Up Clinical Research Associate @ICON plc

Role Description

As a Study Start-Up Clinical Research Associate at ICON, you will be responsible for managing site-level study start-up activities from site selection through to site activation, ensuring clinical trial sites are activated efficiently and in accordance with ICH-GCP, local regulatory requirements, and applicable SOPs.

In this role, you will take ownership of end-to-end study start-up activities for assigned clinical trial sites, acting as a key point of contact for investigational sites and collaborating closely with internal study teams to achieve start-up milestones.

• 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, including responding to queries and resolving 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, ensuring documentation is complete, accurate, and inspection-ready.
• Partner with sites and internal stakeholders to proactively resolve start-up issues, support vendor, contract, and investigator payment activities where required, and minimise activation delays.
• Ensure sites are fully prepared for site activation and coordinate a seamless handover to the execution CRA.

Qualifications

• 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.

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• 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.
• Benefits may vary depending on role and location.

Company Description

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.