Senior Study Start Up Associate (Regulatory Submissions)
HybridSão Paulo, São Paulo, Brazil
Job Summary
Prepare site documentation for regulatory submissions CEP/CONEP and ensure timely ethics submission of protocol and study documents for local IRB approval. Coordinate all activities for site activations and maintenance, forecasting CDP and activation approval dates while documenting risks and mitigations. Prepare, collect, and collate requirements for Critical Package Documents, including accurate site adaptation of Patient Informed Consents and coordination of necessary translations. Act as the escalation point of contact to resolve issues and communicate Sponsor instructions to sites, ensuring successful project outcomes. Requires ethics submission experience and fluency in English; hybrid employment with contingent legal right to work.
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
- Legal right to work in the country where the role is based
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