Site Management Associate I

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

📋 Description

• Provide essential support for clinical research initiatives.

• Optimize communication, uphold systems, and oversee documents and information.

• Serve as the primary liaison between site personnel and CRA for resolving queries and completing EDC.

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

• Ensure local site facilities complete pre-study testing.

• Assist Monitors in finalizing subject and site event information in CTMS.

• Monitor the resolution progress of site-related issues and action items in CTMS.

• Handle 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 site, TMF, and systems audits and inspections.

• Manage the TMF at both site and country levels and file relevant documents.

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

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

• Review the status of document management and translation.

• Ensure proper flow of safety information with investigative sites.

⛳️ Requirements

• Bachelor's degree in Life Sciences.

• Experience in administrative roles, ideally within international contexts.

• Previous experience as a CTA for CROs is preferred.

• Background in Clinical Research is required.

• Familiarity with local regulations.

• Full working proficiency in English is essential.

• Proficient in MS Office applications.

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

• Strong communication and collaboration skills.

• Only CVs submitted in English will be considered.

🏝️ Benefits

• Employees have the option to work remotely.

• Opportunity to enhance your career in clinical research.

• Chance to coordinate various tasks and acquire new skills while growing with the company.