Site Management Associate I

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

📋 Description

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

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

• Oversee the completion of pre-study evaluations of local site facilities, including scans, MRI/CT qualification questionnaires, and test ECGs.

• Support Monitors in the timely entry of subject event and site event information into the Clinical Trial Management System (CTMS).

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

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

• Ensure compliance with regulatory and ethics committee submissions and notifications, remaining informed about local regulations and requirements.

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

• Oversee the TMF at both the site and country level, regularly filing documents.

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

• Organize and monitor initial and ongoing project training for site teams related to vendor systems.

• Review the document management and translation status of the study.

• Ensure effective communication of safety information with investigative sites.

⛳️ Requirements

• Bachelor's degree in Life Sciences.

• Experience in administrative roles, preferably in international settings.

• Previous experience as a Clinical Trial Assistant (CTA) for Contract Research Organizations (CROs).

• Background in Clinical Research.

• Familiarity with local regulations.

• Proficient in English with full working capability.

• Competence in MS Office applications.

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

• Strong communication and teamwork skills.

• Only CVs submitted in English will be considered.

🏝️ Benefits

• Opportunity for remote work.

• Career growth prospects in clinical research.

• Chance to coordinate diverse tasks and acquire new skills.

• Potential for personal and professional growth within the company.