Site Management Associate I

PSI CRO; Municipio de Esquel; Presencial; ARS 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

PSI CRO is seeking an experienced Clinical Trial Administrator/CTA to support international clinical research projects in Argentina. The role focuses on site coordination, documentation management and regulatory submissions, ensuring data quality and logistics across CTMS, ISF, ISF checklists and vendor coordination.

Candidates should hold a Life Sciences degree, have experience as a CTA for CROs, and be proficient in English and MS Office.

Formación

• Degree in Life Sciences required.
• Experience as a CTA for CROs preferred.
• Experience in clinical research.
• Proficient in English and MS Office.
• Knowledge of local regulations.
• Experience in international settings is beneficial.

Responsabilidades

• Be the main point of contact between site personnel and CRA for queries 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 CTMS data and site event information entries; track issues.
• Manage ordering, receipt, inventory storage, distribution, recall and reconciliation of clinical supplies.
• Ensure regulatory and ethics submissions and notifications are up to date.
• Coordinate site, TMF and system audits and inspections.
• Manage TMF at site and country level; file ISF and ISF checklists.
• Arrange and track site training for vendor-related systems.
• Review document management and translation status.

Conocimientos

English proficiency

Communication and collaboration skills

Team-oriented planning

Administrative work experience

Local regulations knowledge

MS Office proficiency

CTA for CROs experience

Clinical research experience

Educación

Bachelor's degree in Life Sciences

Herramientas

MS Office

Descripción del empleo

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

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.

Qualifications

• 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.

Additional Information

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