Clinical Site Coordinator | Hybrid (Mexico City)

Psi CRO; Ciudad de México; Híbrido; MXN 446.000 - 781.000; Jornada completa

Descripción de la vacante

Psi CRO in Mexico City is seeking a proactive Clinical Research Coordinator to support site-wide activities and liaise between site personnel and CRA. You will help with query resolution, EDC completion, vendor coordination, and management of study documents.

This role requires a Life Sciences degree, English proficiency, and experience with clinical research, regulatory knowledge, and MS Office. The position offers a hybrid work arrangement and the opportunity to grow within a global CRO.

Formación

• College/University Degree in Life Sciences.
• Administrative work experience, preferably in an international settings.
• 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.

Responsabilidades

• Be 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.

Conocimientos

English proficiency

Communication & collaboration

MS Office

Teamwork

Planning

Educación

College/University Degree in Life Sciences

Descripción del empleo

Psi CRO in Mexico City is seeking a proactive Clinical Research Coordinator to support site-wide activities and liaise between site personnel and CRA. You will help with query resolution, EDC completion, vendor coordination, and management of study documents.

This role requires a Life Sciences degree, English proficiency, and experience with clinical research, regulatory knowledge, and MS Office. The position offers a hybrid work arrangement and the opportunity to grow within a global CRO.