Site Management Associate I

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

📋 Description

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

• Function as the primary contact for sites regarding vendors, study supplies, and access management.

• Ensure that pre-study assessments of local site facilities are completed, including scans, MRI/CT qualification questionnaires, and test ECGs.

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

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

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

• Ensure regulatory and ethics committee submissions and notifications are completed, staying updated with local regulations and requirements.

• Coordinate preparations and follow-ups for site, Trial Master File (TMF), and systems audits and inspections.

• Manage the TMF at both the site and country levels, ensuring documents are regularly filed.

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

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

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

• Ensure effective communication of safety information with investigative sites.

⛳️ Requirements

• Only CVs submitted in English will be considered.

• A College/University Degree in Life Sciences is required.

• Experience in administrative roles, preferably in international contexts.

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

• Prior involvement in Clinical Research is essential.

• Knowledge of local regulations is necessary.

• Full working proficiency in English is required.

• Proficiency in MS Office applications is needed.

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

• Strong communication and collaboration skills are important.

🏝️ Benefits

• Employees have the option to work remotely.

• Opportunities to advance your career in clinical research, coordinating diverse tasks and acquiring new skills while growing with the company.