Clinical Site Operations Associate I

SmartRecruiters, Inc.; Bogotá ciudad; Híbrido; COP 42.000.000 - 60.000.000; Jornada completa

Descripción de la vacante

SmartRecruiters, Inc. seeks a clinical research professional to support international projects in Bogotá on a hybrid basis. You will coordinate site communications, manage CTMS entries, and ensure regulatory submissions and training are up to date.

The role emphasizes document management, vendor liaison, site audits, and TMF maintenance with focus on accuracy and timely information flow across teams.

Only CVs in English accepted; prior CTA/CRO experience and a Life Sciences degree are preferred.

Formación

• College/University Degree in Life Sciences.
• Administrative work experience, preferably in international settings.
• Prior experience working as CTA for CROs.
• Prior experience 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.

Responsabilidades

• Be the main point of contact between site personnel and CRA involved in the project; assist with query resolution and EDC completion.
• Serve as the primary site contact for vendors, study supplies, and access management.
• Ensure pre-study testing (scans, qualification questionnaires, ECGs) at local site facilities is completed.
• Assist Monitors in CTMS data entry and track site issues and actions.
• Manage the order, receipt, inventory, distribution, return/recall and reconciliation of clinical supplies.
• Coordinate regulatory submissions and ethics committee notifications; stay updated on local rules.
• Prepare for and follow up on site, TMF and system audits/inspections.
• Maintain site and country TMF; file ISF and ISF checklists; distribute and update ISF.

Conocimientos

Administrative work experience

MS Office proficiency

Communication and collaboration

Team-oriented planning

Educación

Life Sciences degree

Herramientas

MS Office

Descripción del empleo

SmartRecruiters, Inc. seeks a clinical research professional to support international projects in Bogotá on a hybrid basis. You will coordinate site communications, manage CTMS entries, and ensure regulatory submissions and training are up to date.

The role emphasizes document management, vendor liaison, site audits, and TMF maintenance with focus on accuracy and timely information flow across teams.

Only CVs in English accepted; prior CTA/CRO experience and a Life Sciences degree are preferred.