Renata Zeigler Ananias Fedeli
Resumo
To work in a Contract Research Organization (CRO) in Clinical Research, Regulatory Affairs, Site Activation, or Study Start-up.
PhD in Microbiology and Immunology (UNIFESP) and Specialist in Clinical Research (BCRI/UNIFENAS), with more than 15 years of experience in clinical research, regulatory affairs, and clinical study management. Experienced in CRO environments, clinical trial coordination, regulatory dossier preparation, ethics and regulatory submissions, site activation, coordination with Ethics Committees and research sites, and review of essential study documentation. Proven expertise in implementing and coordinating Research Ethics Committees, developing SOPs, training multidisciplinary teams, and monitoring performance indicators. Strong knowledge of ICH-GCP and Brazilian clinical research regulations.
Visão geral
21
21
years of professional experience
Experiência profissional
Ethics Committee Coordinator
Galen Academy
2025.01 - 2026.07
- Coordinate all Ethics Committee activities.
- Train staff on ethical and regulatory requirements.
- Represent the institution and oversee ethics review processes.
Senior Regulatory Affairs Analyst
BCRI
2022.01 - 2026.07
- Prepare regulatory dossiers.
- Coordinate site activation activities.
- Liaise with Ethics Committees and research sites.
- Review and validate essential study documentation.
- Review SOPs and quality documents.
Senior Research Analyst / Ethics Committee Coordinator
Escola Paulista de Ciências Médicas
2019.01 - 2024.01
- Implemented and coordinated the Research Ethics Committee.
- Managed scientific projects and events.
- Developed research partnerships.
Senior Research Analyst / Ethics Committee Coordinator
Instituto Jô Clemente
2014.01 - 2022.01
- Implemented the Research Ethics Committee.
- Managed research projects.
- Provided training on research ethics regulations.
Clinical Research Coordinator
AFIP
2006.01 - 2010.01
- Coordinated clinical trials.
- Supported monitoring visits.
- Completed CRFs and resolved queries.
- Prepared regulatory dossiers.
- Reviewed protocols, SOPs, and Quality Manuals.
Formação acadêmica
PhD - Microbiology and Immunology
Federal University of São Paulo
Specialization - Clinical Research
BCRI
Bachelor's Degree - Biological Sciences
Mackenzie Presbyterian University
Habilidades e competências
- Clinical Research
- Regulatory Affairs
- Site Activation
- Study Start-up
- ICH-GCP
- Brazil Platform (Plataforma Brasil) / CEP-CONEP
- Regulatory Dossiers
- Clinical Trial Coordination
- Essential Documents (ISF/TMF)
- CRF/eCRF & Query Resolution
- SOP Development
- Team Training
- Performance Metrics
Languages
Portuguese
English
Spanish
Linha do tempo
Ethics Committee Coordinator
Galen Academy
2025.01 - 2026.07
Senior Regulatory Affairs Analyst
BCRI
2022.01 - 2026.07
Senior Research Analyst / Ethics Committee Coordinator
Escola Paulista de Ciências Médicas
2019.01 - 2024.01
Senior Research Analyst / Ethics Committee Coordinator
Instituto Jô Clemente
2014.01 - 2022.01
Clinical Research Coordinator
AFIP
2006.01 - 2010.01
PhD - Microbiology and Immunology
Federal University of São Paulo
Specialization - Clinical Research
BCRI
Bachelor's Degree - Biological Sciences
Mackenzie Presbyterian University