CPQuali - Estagiário em Pesquisa Clínica (Regulátorio)
Core
Assist the team in detailed analysis and submission of the entire documentation cycle to the CEP/CONEP system via Plataforma Brasil, supporting clinical trial initiation, monitoring, and closure.
Role type
Clinical Research Regulatory Intern
Builds
Clinical trial documentation packages and regulatory submissions
Domain
Clinical research / Regulatory affairs
Deliverable
client delivery
Required skills
Document analysis, Regulatory system navigation (Plataforma Brasil), Clinical trial lifecycle support, File organization, Event reporting (SAEs)
Preferred skills
Office Suite (Word, Excel, PowerPoint), English (intermediate to advanced), Biomedicine or Pharmacy background
Responsibilities
Prepare initial and amendment documentation packages, Support monitors during study visits, Ensure integrity of Investigator Site Files (ISF), Submit reports on adverse events and trial progress
Seniority
Intern