Updated: Today
Location: Tlalnepantla, MEX, Mexico
Job ID:
This Clinical Research Associate (CRA I) role involves overseeing the integrity of clinical research studies by conducting site qualifications, monitoring, and ensuring compliance with regulatory and protocol standards.
Job Responsibilities - Perform site qualification, initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP, Good Pharmacoepidemiological Practices (GPP) and protocol compliance; evaluate overall site performance, recommend actions and develop action plans.
- Verify informed consent procedures are adequately performed and documented; protect confidentiality; assess factors that might affect subject safety and data integrity.
- For the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assess site processes.
- Conduct source document review of si...