Study Start Up Associate II / Senior (Regulatory Submissions)
HybridSão Paulo, São Paulo, Brazil or Mexico City, Mexico City, Mexico
Job Summary
Prepare site documentation for regulatory submissions (CEP/CONEP) and ensure timely ethics approvals for local IRB requirements. Coordinate site activations and maintenance tasks, forecasting CDP and activation dates while documenting risks and implementing contingency plans. Customize patient informed consents, manage critical package documents, and oversee translation verification for all start-up and maintenance materials. Act as the primary escalation point for sites, resolving issues to ensure positive customer experiences and optimize performance across studies. Maintain expert knowledge of ICON SOPs, ICH/GCP, and applicable country regulations to support successful project outcomes.
Required Qualifications
- 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
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Desired Qualifications
- 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 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
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