CRA I (Ciudad de México)

CRA I (Ciudad de México)

15 oct
|
Fortrea
|
Ciudad de México

15 oct

Fortrea

Ciudad de México

We’re looking for an experienced Clinical Research Associate (CRA) to join our team ?✨
If you’re passionate about clinical research, enjoy working closely with investigative sites, and want to contribute to high-quality clinical trials, this could be a great opportunity for you.
What you’ll do:
• Independently manage and monitor clinical trial sites in accordance with ICH-GCP, SOPs, study requirements, and applicable regulations.
• Conduct Pre-Study, Site Initiation, Routine/Process Monitoring, and Close-Out Visits.
• Help protect patient safety by ensuring informed consent, eligibility, and protocol requirements are followed.
• Review source documentation and study data to ensure accuracy, completeness, and data integrity.
• Identify and follow up on queries, deviations, discrepancies, and corrective actions.
• Maintain site regulatory documentation and support eTMF and audit readiness throughout the study.
• Oversee investigational product accountability and study supplies as required.
• Track and follow up on Serious Adverse Events (SAEs) when assigned.




• Prepare accurate and timely monitoring visit reports.
• Collaborate closely with sites and study teams to keep key study milestones and deliverables on track.
• Support site training, Site Initiation Visits, investigator meetings, and project meetings.
• Contribute to the development and implementation of monitoring plans and, when assigned, take on Lead CRA responsibilities.
• Support the training and development of colleagues through activities such as co-monitoring.

What we’re looking for:
✅ University/college degree or relevant healthcare qualification. Equivalent experience may also be considered.
✅ Minimum 2 years of Clinical Monitoring experience.
✅ Experience independently monitoring clinical trial sites.
✅ Strong understanding of ICH-GCP, monitoring procedures, and local regulatory requirements.
✅ Familiarity with CTMS/eClinical systems and eCRF review.
✅ Strong organizational, communication, analytica

📌 CRA I (Ciudad de México)
🏢 Fortrea
📍 Ciudad de México

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