Study Start Up Associate II / Senior (Regulatory Submissions)

Site Partner - Hybrid - Moema / São Paulo

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Site Partner to join our diverse and dynamic team. As a Site Partner at ICON, you will independently manage relationships with a portfolio of investigator sites, supporting their engagement and performance across studies. You will act as a trusted liaison, advocating for site needs internally while supporting ICON processes and expectations.

What You Will Be Doing:

• Preparation and supply of site documentation required for regulatory submissions CEP/CONEP. in CROs

• Ensure timely ethics submission of protocol and study documents/safety reports for local ethics/IRB approval according to local requirements.
• Expert knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems
• Accountable for the expert level independent and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s) across a single or multiple studies.
• In collaboration and feedback from the site, ensure CDP and Site Activation approval dates are forecast and planned accurately in ICON’s systems, documenting all risks to delivery with mitigations taken, as they occur.
• Drive CDP and site activation timelines and ensure they are reflected accurately in ICON’s systems and are achieved; proactively follow through for achievement to/or ahead of plan; provide risk assessment and contingency plans at a site and country level, to mitigate impact if forecasted timelines are at risk; escalate issues as soon as identified
• Accurate site and country adaptation and customization of Patient Informed Consents
• Prepare, collect and collate all requirements for site Critical Package Documents (CDPs) for review and approval prior to site activation in accordance with ICON SOPs/WPs, Sponsor requirements, applicable country regulations/guidelines and the principles of ICH/GCP, ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the TMF.
• Coordination, verification and back translation of all necessary translations required for any start-up or maintenance documentation.
• May be involved in the Site Selection tasks and qualification of a given site
• Act as site liaison and escalation point of contact; proactively resolving issues to ensure the site receives a positive customer experience.
• Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes
• Communicate all relevant Sponsor / FSA Project Manager /Country / CTM instructions or updates to the Site
• Assume responsibility as Subject Matter Expert (SME) for the required topics, ensuring knowledgeable and updated in any changing regulatory requirements.

Your Profile:

• • Bachelor’s degree in life sciences, healthcare, business, or a related field, or equivalent clinical research experience.
  • Experience with ethics submissions (CEP/CONEP) within CROs.
  • Experience in site-facing roles such as Study Start-Up, Regulatory Associate, Site Activation Specialist, Site Activation Coordinator, or similar positions within CROs.
  • Experience in country ICF preparation.
  • Experience with MoH submissions is considered a strong plus and may be required to support these processes.
  • Fluent in English (written and spoken).
  • Good understanding of site operations and factors influencing recruitment and quality.
  • Organized and proactive, with the ability to manage multiple sites and competing priorities.
  • Collaborative team player with a commitment to delivering a high-quality site experience.

#LI-Hybrid

#LI-FP1

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.

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