Site Management Associate I

Psi CRO; Santiago; Híbrido; CLP 12.000.000 - 19.000.000; Jornada completa

Descripción de la vacante

Psi CRO is seeking a capable Clinical Trial Assistant to support international clinical research projects. You will streamline communication, maintain systems, and manage documents across sites and vendors.

The role requires English proficiency and prior CRO/CTA experience, with responsibilities spanning CTMS, ISF, regulatory submissions, and study material logistics. Join a global team and advance your career in clinical research.

Formación

• College/University Degree in Life Sciences.
• Administrative experience in international settings.
• Prior CTA experience for CROs.
• Experience in Clinical Research.
• Knowledge of local regulations.
• Fluent in English.
• Proficient with MS Office.
• Ability to plan and work in a dynamic team.
• Excellent communication and collaboration.

Responsabilidades

• Be the main point of contact between site personnel and CRA; assist with queries and EDC completion.
• Act as the primary site contact for vendors, study supplies and access management.
• Ensure pre-study testing (scans, MRI/CT forms, ECGs) is completed at sites.
• Assist Monitors in CTMS data entry; track issue resolution and actions.
• Manage order, receipt, inventory, distribution, return/recall and reconciliation of supplies.
• Ensure regulatory submissions and ethics notifications are up to date.
• Coordinate site, TMF, and systems audits and inspections.
• Manage TMF at site/country level; file ISF and ISF checklists.
• Arrange and track training for site teams in vendor systems.
• Review document management and translation status for the study.
• Ensure safety information flow with investigative sites.

Conocimientos

Communication skills

Team collaboration

English proficiency

MS Office proficiency

Planning ability

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 than2,800 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 filedocuments. 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 planand 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.

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