Clinical Operations Intern

I am a pharmacy student at the Federal University of São Paulo (UNIFESP) with a strong focus on clinical research and clinical operations. My academic background has given me a solid foundation in pharmaceutical sciences, while my practical experience has helped me build hands-on knowledge in research center activation, regulatory workflows, and study documentation.

I am currently working at Roche as a Clinical Operations Intern, where I support regulatory management, feasibility activities, contract formalization, and study start-up procedures. I also work with eTMF organization in Veeva Vault, manage essential documents, and help ensure traceability and compliance for study closure.

Before Roche, I worked at Centryc Consultoria Estratégica as a Clinical Trial Assistant, where I supported study protocols, informed consent forms, safety reports, and data collection. I also handled participant records and maintained demographic and regulatory documentation, which strengthened my attention to detail and operational discipline.

Earlier in my career, I completed an internship in Clinical Research at Centryc Consultoria Estratégica, where I organized study files, prepared an archives manual, and contributed to research center activities. This experience helped me develop a practical understanding of TMF, ISF, and IF organization, as well as scientific review processes.

I have experience working with regulatory and ethical processes involving ANVISA and CEP/CONEP, and I am comfortable supporting translations and document packages for study activation. I also have experience using systems such as Veeva Vault, Veeva RIM, SIP, and eTMF, which are essential tools in clinical operations.

I speak English at an advanced level and Spanish at an intermediate level. I am motivated to continue growing in clinical research and clinical operations, with a particular interest in supporting efficient, compliant, and well-organized study execution.