Study Start Up Clinical Research Associate

🔥 44 minutes ago

🇰🇪 Kenya – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ 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

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