Study Start Up Clinical Research Associate

Study Start Up Clinical Research Associate

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

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.

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.

What You Will Do:

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.

Key responsibilities include:

• 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

Your Profile:

To succeed in this role, you will bring strong clinical trial study start-up and regulatory experience, with the ability to independently manage site activation activities and regulatory submissions.

Required qualifications and experience:

• 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.

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

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply