CRA II: Medical Device Clinical Trials Specialist

Abbott; Alameda (CA); Presencial; USD 82.000 - 141.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

Retirement plan

Tuition reimbursement

Descripción de la vacante

Abbott is seeking a Clinical Research Associate II to support the clinical execution and management of assigned studies. The role is based in Alameda, CA, with responsibilities spanning study planning, site monitoring, and regulatory readiness.

The candidate will conduct site visits, manage monitoring activities, and assist in trial documentation, ensuring GCP and regulatory compliance while working with cross-functional teams to deliver study milestones.

Formación

• BS in life sciences or equivalent with 5 years clinical research experience.
• 2+ years of site monitoring experience.
• Experience with medical device and/or in-vitro diagnostics studies preferred.

Responsabilidades

• Conduct single or multi-center medical device clinical studies.
• Perform study site visits (SQV, SIV, IMV, COV) and generate monitoring trip reports.
• Manage clinical monitoring activities and ensure compliance with study protocols and GCPs.
• Maintain and audit Trial Master File and assist regulatory submissions.
• Communicate study status to management and coordinate cross-functional teams.

Conocimientos

Clinical research

Site monitoring

Teamwork

Communication

Project management

Educación

BS in life sciences

Herramientas

Microsoft Office Suite

Descripción del empleo

Abbott is seeking a Clinical Research Associate II to support the clinical execution and management of assigned studies. The role is based in Alameda, CA, with responsibilities spanning study planning, site monitoring, and regulatory readiness.

The candidate will conduct site visits, manage monitoring activities, and assist in trial documentation, ensuring GCP and regulatory compliance while working with cross-functional teams to deliver study milestones.