Coordinador de Ensayos Clínicos – En Sitio, Impacto Global

Psicro; Tuxpan; On-site; MXN 420,000 - 550,000; Full time

Job summary

Psicro is seeking a Milestone One Site Coordinator to support trial sites in accordance with ICH-GCP and protocol requirements. You will act as the primary liaison between Sponsor/CRO and the site, managing feasibility responses and coordinating monitoring visits.

Responsibilities include tracking patient enrollment, data entry into EDC systems, regulatory document handling, and supporting contract negotiations. On-site presence and strong communication skills are essential.

Qualifications

• College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• Upper-intermediate level of English, with the ability to work in a global team environment.

Responsibilities

• Act as the main line of communication between the Sponsor or CRO and the site.
• Ensure response to feasibility questions are provided in due time.
• Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center.
• Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.
• Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
• Maintain study specific and general tracking of documents at the site level.
• Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.
• Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations.
• Proper handling, accountability and reconciliation of investigational products and clinical supplies.
• Collect, handle and maintain all site-specific regulatory documents as needed.
• Facilitate and support the contract and budget negotiations at the site level.
• Support Investigator and Site payments and processes as needed.
• Schedule and/or perform study procedures as per study requirements and delegation of responsibilities.
• Prepare for and participate in onsite study audits or regulatory agency inspections.
• Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).

Skills

Communication

English

Education

Life Science degree

Job description

Psicro is seeking a Milestone One Site Coordinator to support trial sites in accordance with ICH-GCP and protocol requirements. You will act as the primary liaison between Sponsor/CRO and the site, managing feasibility responses and coordinating monitoring visits.

Responsibilities include tracking patient enrollment, data entry into EDC systems, regulatory document handling, and supporting contract negotiations. On-site presence and strong communication skills are essential.