Site Management Associate I

Psicro; Colombia; Presencial; COP 25.000.000 - 42.000.000; Jornada completa

Descripción de la vacante

Psicro is seeking an organized professional to support clinical research projects as a CTA, coordinating documentation, site communications, and TMF processes across sites.

You will be responsible for regulatory submissions, CTMS data entry, management of study materials, translations, and training for site teams, while maintaining English fluency and strong MS Office skills in a dynamic international setting. Join an international team and contribute to high-quality trial delivery.

Formación

• College/university degree in life sciences or related field.
• Proficiency in MS Office applications.

Responsabilidades

• Being the main point of contact between site personnel and CRA involved in the project, helping with query resolution and EDC completion.
• Serve as the primary site contact for vendors, study supplies, and access management.
• Ensure pre-study testing of local site facilities is completed.
• Assist in CTMS data entry and site event documentation.

Descripción del empleo

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.

Required 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.

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.