Study Start Up Associate I

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client´s standards.  

• Coordinate site start-up activities and essential document management to compile a high-quality Investigator Initiation Package (IIP) for site approval.

• Support issue resolution, escalate site concerns as needed, and ensure timely regulatory submissions, including IIP, IRB approvals, and FDA 1572/Attestation.

• Collaborate with stakeholders to achieve timely site activation and operational readiness while assisting with IRB/ethics submissions and approvals per local regulations.

• Facilitate communication and documentation between sites, ethics committees, and the study team.

• Manage essential documents throughout the study, including protocol amendments, FDA 1572 revisions, and annual IRB approvals, ensuring IRB/ethics compliance and proper documentation.

• Maintain clinical trial tracking systems to monitor site compliance and performance, filing study documents in the Trial Master File and conducting periodic quality reviews.

• Support investigator sites and study teams in audit/inspection readiness.

• Act as a primary contact for investigator sites, study teams, and stakeholders by providing site status updates, communicating approvals, and escalating delays.

• Conduct site awareness sessions to ensure compliance with study requirements and regulations.

• Identify and resolve site issues, coordinating corrective actions to prevent recurrence and maintain smooth trial operations.

• Diploma/certificate or BS/BA in life sciences preferred, with 2+ years of clinical site management experience.

• Experience in pharmaceutical/CRO study site activation is a plus, with knowledge of ICH/GCP, FDA, and global/local regulations.

• Fluent in Czech language and English

• Strong understanding of clinical research, trial operations, and compliance requirements.

• Detail-oriented with strong organizational and multitasking abilities.

• Ability to work independently and collaboratively in a team.

• Familiarity with medical terminology, GCP, and clinical trial systems.

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.