Site Management Associate I

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

📋 Description

• Act as the primary liaison between site personnel 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 point for vendors, managing study supplies and access.

• Ensure that pre-study evaluations of local site facilities are performed, which includes scans, MRI/CT qualification questionnaires, and test ECGs.

• Support Monitors in the timely completion of subject event and site event data 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 conducted, remaining informed on local regulations and their outcomes.

• 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, regularly filing documents as necessary.

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

• Only resumes in English will be considered.

• Bachelor’s Degree in Life Sciences.

• Experience in administrative roles, ideally in international environments.

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

• Prior background in Clinical Research.

• Knowledge of local regulations.

• Full working proficiency in English.

• Proficiency in Microsoft Office applications.

• Capability to plan and work effectively in a dynamic team setting.

• Strong communication and collaboration skills.

🏝️ Benefits

• Employees have the option to work remotely.

• Opportunities to advance your career in clinical research.

• Engage in a variety of tasks while acquiring new knowledge and growing with the company.