Alan Rodrigus Vianna

Clinical Research Regulatory Affairs Coordinator @ Instituto Dante Pazzanese de Cardiologia - IDPC

About

Clinical Research Regulatory Affairs professional focused on regulatory timeline optimization, process automation, and elimination of rework in clinical research studies. Hands-on experience with Brazilian Ethics Committees (CEP/CONEP) and Plataforma Brasil, leading initial submissions, amendments, safety reports, informed consent forms (ICF), and essential regulatory documentation in compliance with ethical and regulatory requirements. Advanced expertise in Excel, VBA, and Power Query, with a strong focus on regulatory process standardization, transforming manual activities into predictable, auditable, and efficient workflows. Collaborative work with investigators, sponsors, and CROs to accelerate regulatory submissions, ensure regulatory compliance, and keep clinical trials on track and within timelines.

Country

Brazil

City

Santo André

Industry

Government Administration

Skill

Resolução de problemas, Inglês, Microsoft Word, Microsoft Office, Padrões regulatórios, Nutrition & Public Health, Team Collaboration in Clinical Research, Document Review & Risk Mitigation in Research, Clinical Trial Ethics & Compliance, Communication with Sponsors, CROs and Investigators, Plataforma Brasil (Submissões & Gestão de Projetos), Research Compliance & Quality Assurance, Clinical Trial Documentation Management, Ethics Committee Submissions (CEP/CONEP), Good Clinical Practice (ICH-GCP R3), Regulatory Affairs in Clinical Research

Experience

Clinical Research Regulatory Affairs Coordinator

Instituto Dante Pazzanese de Cardiologia - IDPC

2025-6 - Present · 1 yr 4 mos

São Paulo, São Paulo, Brasil

Hands-on role in Clinical Research Regulatory Affairs, with a primary focus on Plataforma Brasil and Brazilian Ethics Committees (CEP/CONEP), ensuring ethical and regulatory compliance and adherence to clinical trial timelines. Responsible for initial regulatory submissions, amendments, safety reports, informed consent forms (ICF) and essential regulatory documentation, including organization, updates, version control and traceability in accordance with ICH-GCP (R3), Brazilian National Health Council (CNS) resolutions and CONEP regulations. Ongoing interface with investigators, sponsors and CROs, supporting ethics approvals, addressing committee queries, preparing responses to CEP/CONEP and providing regulatory support during audits and monitoring visits. Role focused on regulatory timeline optimization, process standardization, prevention of rework and continuous strengthening of regulatory compliance within the clinical research center.