Site Management Associate I

Psicro; Argentina; Presencial; ARS 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

Psicro is seeking a proactive, detail‑oriented clinical research support specialist to streamline communication, maintain systems, and manage documents for international projects.

You will be the main site contact for CRA queries, coordinate TMF and ISF activities, ensure regulatory submissions, and support site training and vendor coordination. Fluency in English and experience in clinical research are required.

Formación

• College/University Degree in Life Sciences.
• Full working proficiency in English.
• Experience working as CTA for CROs and in Clinical Research.
• Knowledge of local regulations and CTMS/ISF processes.
• Ability to plan and work in a dynamic team environment.

Responsabilidades

• Being the main point of contact between site personnel and CRA; assist in query resolution and EDC completion.
• Serve as primary site contact for vendors, study supplies, and access management.
• Ensure pre-study testing of local site facilities is completed.
• Assist Monitors with subject/event data in CTMS and track issue resolution.
• Manage TMF, ISF files, and site/country level document handling and audits.
• Coordinate site training for vendor-related systems and translations status review.
• Ensure safety information flow with investigative sites.

Conocimientos

Communication skills

Teamwork

Planning

English proficiency

MS Office

Educación

College/University Degree in Life Sciences

Herramientas

MS Office

Descripción del empleo

Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.

You will be responsible for:

• Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion.
• Serves as the primary sites' contact point for vendors, study supplies, and access management.
• Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
• Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS.
• Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
• Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.
• Coordinate preparation for and follow-up on site, TMF and systems` audits and inspections.
• Manage the TMF on a site and a country level for regularly and file documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
• Arrange and track initial and on-going project training for site teams in all vendor-related systems.
• Document Management and translations status review of the study.
• Ensures proper safety information flow with investigative sites.

• College/University Degree in Life Sciences;
• Administrative work experience, preferably in an international settings;
• Prior experience working as CTA for CROs;
• Prior experience working in Clinical Research;
• Local regulations knowledge;
• Full working proficiency in English;
• Proficiency in MS Office applications;
• Ability to plan and work in a dynamic team environment;
• Communication and collaboration skills.

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.