Lead Clinical Monitoring CRA

FTMEX Fortrea Clinical Development Mexico S.DeR.L.DeC.V.; Ciudad de México; On-site; MXN 480,000 - 720,000; Full time

Job summary

Fortrea is seeking an experienced Clinical Research Associate to manage site monitoring for multiple clinical studies in Mexico, following Fortrea SOPs and ICH GCP.

Responsibilities include site visits, informed consent verification, data integrity checks, preparation of monitoring plans, and ensuring regulatory readiness. Travel up to 60% and collaboration with study teams are required; strong English and local language skills are essential; prior CRA experience is preferred.

Qualifications

• University or college degree, or certification in a related allied health profession, e.g., nursing licensure.
• Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
• Experience with site monitoring procedures and data integrity controls.

Responsibilities

• Perform site monitoring visits per SOPs and ICH GCP.
• Verify informed consent and patient safety compliance.
• Ensure data integrity via source data verification and query resolution.
• Prepare monitoring plans and trip reports; track IP shipments.
• Collaborate with study team, investigators, and sponsors to meet timelines.

Skills

GCP guidelines

Monitoring procedures

English proficiency

Attention to detail

Problem solving

Team collaboration

SOP understanding

Education

Nursing licensure

Tools

CTMS

eClinical systems

Job description

Fortrea is seeking an experienced Clinical Research Associate to manage site monitoring for multiple clinical studies in Mexico, following Fortrea SOPs and ICH GCP.

Responsibilities include site visits, informed consent verification, data integrity checks, preparation of monitoring plans, and ensuring regulatory readiness. Travel up to 60% and collaboration with study teams are required; strong English and local language skills are essential; prior CRA experience is preferred.