Site Management Associate

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Act as the primary liaison between site personnel and the Clinical Research Associate (CRA) involved in the project, facilitating query resolution and Electronic Data Capture (EDC) completion.

• Serve as the main contact for vendors, study supplies, and access management at the site.

• Ensure completion of pre-study assessments of local site facilities.

• Assist Monitors in the timely completion of all subject event and site event details in the Clinical Trial Management System (CTMS).

• Monitor the resolution status of site-related issues and action items within the CTMS.

• Oversee the ordering, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies.

• Ensure that regulatory and ethics committee submissions and notifications are completed.

• Coordinate the preparation and follow-up for site, Trial Master File (TMF), and system audits and inspections.

• Manage the TMF at both the site and country levels, ensuring regular filing of documents.

• Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.

• Organize and monitor initial and ongoing project training for site teams regarding all vendor-related systems.

• Review the status of document management and translations for the study.

⛳️ Requirements

• Bachelor's or University Degree in Health Sciences.

• Experience in administrative roles.

• Previous experience in Clinical Research.

• Familiarity with local regulations.

• Full working proficiency in both English and Portuguese.

• Proficiency in Microsoft Office applications.

• Ability to plan effectively and collaborate in a dynamic team environment.

• Strong communication and teamwork skills.

🏝️ Benefits

• Opportunities for professional development.

• Options for remote work.