Site Management Associate I

PSI CRO; Buenos Aires; Presencial; ARS 48.292.000 - 78.474.000; Jornada completa

Descripción de la vacante

PSI CRO is seeking a results-driven Clinical Trial Support professional to join our international team in Argentina. You will act as the principal liaison between site staff and CROs, ensuring smooth query resolution and EDC completion.

You will manage vendor relations, study supplies, access controls, and regulatory submissions. The role requires experience in clinical research, strong English communication, and adept coordination of TMF and site documents across projects.

Formación

• Experience in coordinating clinical research projects or CTAs.
• Strong communication with sites, vendors and CROs.
• Familiarity with regulatory submissions and ethics approvals.
• Proficiency in English, both written and spoken.

Responsabilidades

• Be the main point of contact between site personnel and CRA for query resolution and EDC completion.
• Primary site contact for vendors, study supplies, and access management.
• Ensure pre-study testing (scans, qualification questionnaires, ECGs) is completed.
• Assist Monitors with CTMS data entry and track site issues in CTMS.
• Manage inventory, distribution, and reconciliation of clinical supplies.
• Ensure regulatory submissions and notifications are up to date.
• Coordinate site, TMF and systems audits/inspections preparation.
• Manage TMF at site and country level; file ISF and ISF checklists.
• Arrange training for site teams on vendor systems.
• Review document management and translation status.

Conocimientos

Administrative experience

CTA for CROs experience

Clinical research experience

English proficiency

MS Office proficiency

Teamwork & communication

Regulatory knowledge

Educación

College/University 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.

Job Description

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

Only CVs in English will be accepted.

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.