Onsite Clinical Research Associate I

Abbott; Alameda (CA); Presencial; USD 74.000 - 116.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free health coverage

Retirement plan with employer match

Tuition reimbursement

Education benefit

Descripción de la vacante

Abbott in Alameda, CA is seeking a Clinical Research Associate to ensure quality, accuracy, and integrity of clinical trial data across multiple studies in compliance with CFR, ICH GCP, and ISO14155. This on-site role requires travel 30-50% and close collaboration with study teams.

You will monitor sites, assist with start-up activities, manage TMF uploads, and support regulatory submissions. A BS in life sciences and 1 year of clinical research experience are preferred; pharma or device study

Formación

• BS degree in life sciences preferred or equivalent with minimum one year of clinical research experience.
• Experience working on medical device studies or in vitro diagnostics preferred.
• Demonstrate teamwork, interpersonal and communication skills with study site staff and management.

Responsabilidades

• Perform study site visits (SQV, SIV, IMV, COV) and generate monitoring reports.
• Assist with clinical monitoring and site management ensuring GCP/ICH CFR compliance.
• Participate in study start-up activities and training of sites.
• Maintain and audit Trial Master File (TMF) and upload to eTMF for inspection readiness.
• Review data listings for completeness and escalate issues as needed.
• Communicate study status to management and assist with regulatory submissions.

Conocimientos

Teamwork

Interpersonal skills

Communication skills

Educación

BS degree in life sciences

Herramientas

Microsoft Suite

Descripción del empleo

Abbott in Alameda, CA is seeking a Clinical Research Associate to ensure quality, accuracy, and integrity of clinical trial data across multiple studies in compliance with CFR, ICH GCP, and ISO14155. This on-site role requires travel 30-50% and close collaboration with study teams.

You will monitor sites, assist with start-up activities, manage TMF uploads, and support regulatory submissions. A BS in life sciences and 1 year of clinical research experience are preferred; pharma or device study