Site Management Associate I

PSI CRO; Bogotá; Presencial; COP 33.000.000 - 60.000.000; Jornada completa

Descripción de la vacante

PSI CRO is seeking a Clinical Trial Support professional in Bogotá to streamline communication, maintain systems, and manage study documents across international projects.

The role requires close collaboration with sites, vendors, and monitors, ensuring regulatory submissions and high-quality TMF management. English proficiency and life sciences background are essential.

Formación

• College/university degree in life sciences.
• Administrative and cross-functional teamwork experience in international settings.
• Experience as CTA for CROs or in clinical research.
• Proficiency with MS Office applications (Word, Excel, PowerPoint).
• Knowledge of local regulations and ethical submissions.
• Full working proficiency in English.

Responsabilidades

• Act as main site-CRA liaison, resolving queries and aiding EDC completion.
• Primary contact for vendors, study supplies, and access management.
• Ensure pre-study testing for site facilities is completed (scans, qualification questionnaires, ECGs).
• Assist Monitors with CTMS data entry and track site issues to resolution.
• Manage course of clinical supplies: order, receipt, storage, distribution, recall, reconciliation.
• Coordinate site, TMF and systems audits/inspections and maintain ISF files.

Conocimientos

Administrative work

Communication skills

Team collaboration

English proficiency

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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