Senior Clinical Research Associate (Mexico)

TL;DR

Senior Clinical Research Associate (Mexico): Overseeing site management for complex clinical trials across Mexico with an accent on patient safety, data quality, and regulatory compliance. Focus on conducting site visits, monitoring activities, risk identification, and mentoring junior staff.

Remote, Mexico. Up to 60% travel on average, based on regional requirements. International travel as needed.

Company

hirify.global is a CRO expanding capabilities across Latin America to support critical clinical studies.

What you will do

• Independently oversee study site management, ensuring patient safety, low query levels, and audit readiness.
• Manage site start-up procedures, including feasibility, EC/IRB submissions, regulatory documents, and investigator contracts.
• Conduct all forms of site visits (pre-study, initiation, routine monitoring, close-out), prepare monitoring reports, and perform monitoring oversight for other CRAs.
• Review and reconcile ISF and TMF, manage IP inventory and accountability, and handle SAE reporting.
• Support recruitment, retention strategies, data review, risk escalation, and participation in investigator/sponsor meetings.
• Mentor junior staff, assist in training, protocol reviews, and client interactions.

Requirements

• 4-year college degree or equivalent in scientific or healthcare discipline.
• 5+ years as CRA in CRO, pharma, or biotech; significant site management experience.
• Ability to communicate proficiently in English (professional level).
• Knowledge of ICH-GCP, local regulations, and clinical trials methodology.
• Up to 60% travel required, international as needed.

Nice to have

• Graduate/postgraduate degree.
• Experience in rare/complex therapeutic areas, EDC trials, EHR records, oncology (early phases).
• Site start-up experience in Mexico (feasibility, contracts, submissions).
• Ability to conduct presentations and work independently in a team.