Study Start Up Clinical Research Associate

ICON

Study Start Up Clinical Research Associate

• Location: Kenya

Reference: JR163168

• Categories Clinical Monitoring

• vacancyopjusttionswidget.opt-Business Area

ICON Strategic Solutions (FSP)

• vacancyopjusttionswidget.opt-Remote Working

Remote

Shortlist Save this role

About the role

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.

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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.

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Location

Kenya

Reference: JR163168

• Categories

Clinical Monitoring

• vacancyopjusttionswidget.opt-Business Area

ICON Strategic Solutions (FSP)

• vacancyopjusttionswidget.opt-Remote Working

Remote

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