Clinical Research Associate I – Remote/On‑site Monitoring
Thermo Fisher Scientific · Argentine
Descripcion del puesto
About the role
Join a global CRO team that supports leading pharmaceutical and biotech companies across more than 100 countries. As a Clinical Research Associate I you will conduct remote and on‑site monitoring visits, ensuring trials follow the approved protocol, ICH‑GCP guidelines and regulatory requirements.
Key responsibilities
- Perform risk‑based monitoring of investigator sites, applying root‑cause analysis and corrective actions.
- Verify data accuracy through source data verification (SDR), source data review (SDV) and case report form (CRF) checks.
- Assess investigational product inventory and documentation.
- Document observations in reports and letters, escalating deficiencies to clinical management.
- Maintain regular communication with sites to confirm protocol compliance and timely data entry.
- Participate in investigator payment processing and site initiation/close‑out activities.
- Support investigator meetings and assist in identifying qualified sites.
Required profile
- Strong understanding of clinical trial processes and regulatory standards.
- Ability to apply critical thinking and problem‑solving skills to site issues.
- Excellent written communication for timely reporting.
- Detail‑oriented with a focus on audit readiness.
Required skills
- Knowledge of ICH‑GCP guidelines.
- Experience with source data verification (SDR) and source data review (SDV).
- Familiarity with investigational product handling and documentation.
What we offer
- Opportunity to work on diverse global clinical trials.
- Collaborative environment with experienced project teams.
- Professional development in clinical monitoring and site management.
Questions fréquentes
Por que reporta esta oferta?
Postula en 30 segundos
Ingresa tu email para postular. Se creara una cuenta automaticamente.
Al continuar, aceptas nuestras condiciones de uso.
Ya tienes cuenta? Iniciar sesion
Publicado hace 20 horas
Expira en 1 mes
11 vistas · 0 candidaturas
Aumenta tus posibilidades
Sube tu CV: te propondremos las ofertas que coinciden con tu perfil.
Analizando tu CV...
Thermo Fisher Scientific
Argentine
Ofertas relacionadas
-
Clinical Research Associate I (CRA Level I)
Thermo Fisher Scientific Argentine -
Medical Professional for U.S. Chiropractic Patient Intake & Documentation
Emma of Torre.ai Argentine -
Médico/a clínico/a para telemedicina
DOCTOR VIRTUAL Argentine -
Assisted Living Surveyor – Facility Survey Consultant
NC Department of Health and Human Services Mar del Plata -
Local Drug Product & Stability Leader
Pfizer Région métropolitaine de Buenos Aires