16 oct
|
Fortrea
|
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 / CRA II (México)
🏢 Fortrea
📍 México