Site Management Associate – I

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

📋 Description

• Become a vital member of our global team, providing essential support for clinical research initiatives.

• Enhance communication, oversee systems, and manage documentation and information effectively.

• Serve as the primary liaison between site personnel and Clinical Research Associates (CRAs) involved in the project.

• Assist in resolving queries and completing Electronic Data Capture (EDC) tasks.

• Act as the main contact for vendors, study supplies, and access management for sites.

• Ensure that pre-study evaluations of local site facilities are conducted successfully.

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

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

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

• Ensure timely submissions and notifications to regulatory and ethics committees.

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

• Manage the TMF at both the site and country levels to ensure documents are filed appropriately.

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

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

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

• Ensure the proper flow of safety information with investigative sites.

⛳️ Requirements

• Bachelor’s or University Degree in Life Sciences.

• Experience in administrative roles, ideally within international contexts.

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

• Prior involvement in Clinical Research.

• Knowledge of local regulations.

• Proficient in English with full working capabilities.

• Competent in MS Office applications.

• Ability to organize and collaborate within a dynamic team environment.

• Strong communication and teamwork skills.

🏝️ Benefits

• Flexible remote work options.