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Biomedicine Student & Clinical Research and Regulatory Affairs Intern
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Sobre
Biomedicine student at the Federal University of Health Sciences of Porto Alegre (UFCSPA), deeply passionate about healthcare and its ecosystem. Inventive, observant, resilient, committed, hardworking, and highly driven. Currently in my final undergraduate year, serving as a Clinical Research Intern in Regulatory Affairs at the Latin American Cooperative Oncology Group (LACOG), as well as a Clinical Research Intern at Hospital Moinhos de Vento (HMV).
Seeking my next professional opportunity to expand my knowledge in the field and perform with high quality and excellence.
Experiência
Clinical Research Intern (Site Level) at Hospital Moinhos de Vento de Porto Alegre (HMV) (2026-03 – Present)
- Organization of investigator binders for monitoring visits.
- Participation in recruitment, screening, and pre-screening of research participants for ongoing studies.
- Assistance and operational support across different departments within the HMV Research Institute.
- Filing and maintenance of essential documents within the Investigator Site File (ISF).
- Execution of administrative and operational activities to ensure the proper workflow and compliance of the Clinical Research Center.
Regulatory Affairs Intern (CRO Level) at Latin American Cooperative Oncology Group (LACOG) (2025-04 – Present)
- Development and submission of Site Inclusion/Exclusion and Principal Investigator (PI) Change amendments.
- Development of Initial Regulatory Packages for Survey-type clinical studies.
- Preparation, development, and submission of mandatory documentation for study regulatory closure.
- Distribution and tracking of safety notifications to investigative sites, including Investigator's Brochures (IBs), SUSARs, and DSURs.
- Follow-up and tracking of amendment submissions and regulatory notifications directly with research sites.
- Filing, maintenance, and organization of essential study documents in the Trial Master File (TMF).
- Updating and managing master tracking spreadsheets with critical regulatory submission details.
- Drafting and developing Standard Operating Procedures (SOPs).
Formação
Bachelor's Degree in Biomedicine – Federal University of Health Sciences of Porto Alegre (UFCSPA) (2021)
