PSI CRO

Global CRO delivering on-time patient enrollment

Site Management Associate 1

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeSantiago, Santiago Metropolitan Region, ChileNo salary listedRemote

About the Job

Requirements

A college or university degree in Life Sciences.
Administrative work experience, preferably in an international setting.
Prior experience working as a Clinical Trial Assistant for contract research organizations.
Prior experience working in clinical research.
Knowledge of local regulations.
Full working proficiency in English.
Proficiency in Microsoft Office applications.
Ability to plan and work in a dynamic team environment.
Communication and collaboration skills.

Responsibilities

Serve as the main point of contact between site personnel and the Clinical Research Associate involved in the project, helping resolve queries and complete electronic data capture.
Serve as the primary site contact for vendors, study supplies, and access management.
Ensure pre-study testing of local site facilities is completed, including scans, MRI/CT qualification questionnaires, and test electrocardiograms.
Assist monitors with promptly completing subject-event and site-event information in the Clinical Trial Management System; track site issue and action-item resolution status in the system.
Ensure the ordering, receipt, inventory storage, distribution, return or recall, and reconciliation of clinical supplies.
Ensure regulatory and ethics committee submissions and notifications are completed, and remain current on local regulations and dispositions.
Coordinate preparation for and follow-up on site, Trial Master File, and systems audits and inspections.
Manage the Trial Master File at site and country levels, including regular filing of documents; prepare, distribute, and update Investigator Site Files and checklists.
Arrange and track initial and ongoing project training for site teams in vendor-related systems.
Review study document management and translation status.
Ensure proper safety-information flow with investigative sites.

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.

About the Company

PSI CRO

Global CRO delivering on-time patient enrollment

PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Switzerland
Founded: 1995

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