CRA I (Ciudad de México)

CRA I (Ciudad de México)

06 nov
|
Fortrea
|
Ciudad de México

06 nov

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, analytical, and problem-solving skills. ✅ Ability to work independently while collaborating effectively in a integral, matrix environment. ✅ Fluent in English and the local office language, both written and spoken. ✈️ Ability to travel approximately 60% of the time to study sites. Nice to have:
• Life Sciences or Nursing background.
• Phase I monitoring experience.
• Additional experience in clinical research, pharmaceutical, medical, laboratory, data management, or related environments.
• Strong attention to detail and a methodical approach to work. Ready for your next step in Clinical Research? If you have solid monitoring experience and are looking for an opportunity to continue growing as a CRA, we’d love to hear from you ?

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

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