Site Management Associate I

Psi CRO; Bogotá ciudad; Híbrido; COP 44.640.000 - 78.120.000; Jornada completa

Descripción de la vacante

Psi CRO in Bogotá is seeking a Clinical Trial Administrator to support international clinical research projects. You will streamline communication, maintain systems, and manage documents and information.

Only CVs in English will be accepted. This hybrid role requires liaison with site personnel, vendors, and study sponsors, ensuring regulatory compliance and quality across CTMS/ISF processes.

Formación

• Life Sciences degree required.
• Administrative experience, preferably in international settings.
• Experience as CTA for CROs and in Clinical Research.
• Knowledge of local regulations.
• Full working proficiency in English.
• Proficient with MS Office applications.
• Ability to plan and work in a dynamic team environment.
• Strong communication and collaboration skills.

Responsabilidades

• Be the main point of contact between site personnel and CRA for query resolution and EDC completion.
• Serve as primary site contact for vendors, study supplies, and access management.
• Ensure pre-study testing (scans, qualification questionnaires, ECGs) is completed.
• Assist Monitors in CTMS data entry and track site issues in CTMS.
• Manage order, receipt, storage, distribution and recall of clinical supplies.
• Ensure regulatory submissions and ethics committee 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 and track site training for vendor-related systems.
• Review document management and translation status of the study.
• Ensure proper safety information flow with investigative sites.

Conocimientos

MS Office

English

Teamwork

Educación

Life Sciences degree

Herramientas

CTMS

eTMF

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.

Hybrid opportunity in Bogotá.

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.