Sr. Clinical Trial Coordinator - Regulatory & Site Start-Up - São Paulo (SP)

Under the oversight of the line manager, this role is responsible for supporting and coordinating Regulatory and Site Start-Up activities, trial administration, and clinical document management. The Sr. CTC - Regulatory ensures timely regulatory submissions, maintenance of essential study documentation, and compliance with applicable regulations and company procedures.

The role is critical to achieving planned Site Ready dates and maintaining inspection-ready documentation throughout the study lifecycle. The position collaborates closely with Clinical Operations, CRAs, investigators, Ethics Committees, Regulatory Authorities, and other cross-functional stakeholders.

Responsibilities include, but are not limited to:

• Trial and Site Administration

• Track essential documents and study reports.
• Ensure distribution and maintenance of study tools and documentation.
• Update CTMS, trackers, and other clinical systems.

• Document Management

• Prepare, distribute, and archive clinical trial documentation.
• Support eTMF maintenance, reconciliation, and quality control activities.
• Prepare Investigator Site Files and coordinate document translations.
• Ensure compliance with Good Documentation Practices (GDP).

• Regulatory & Site Start-Up

• Support collection and management of site start-up documentation.
• Prepare and track submissions to Ethics Committees (IRB/ERC) and Regulatory Authorities.
• Maintain study insurance documentation and regulatory trackers.
• Support site activation activities and publication of study results when required by local regulations.

• Quality & Oversight

• Act as a Subject Matter Expert (SME) for selected processes.
• Support continuous improvement initiatives and best practice sharing.
• Mentor and provide guidance to junior CTC team members.

Main Requirements:

• Bachelor's Degree required.
• Fluent in Portuguese and business proficient in English.
• Experience in Regulatory Affairs, Site Start-Up, Clinical Trial Administration, or related clinical research functions.
• Strong knowledge of ICH-GCP, Good Documentation Practices (GDP), and local regulatory requirements.
• Experience with CTMS, eTMF, and Microsoft Office applications.
• Strong organizational, communication, and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to work independently and effectively within a matrix and multicultural environment.

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