Clinical Research Associate I: Launch Your Trials Career

Abbott; Alameda (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott is seeking a Clinical Research Associate I to ensure quality and integrity of clinical trial data across multiple studies in Alameda, CA. This on-site role supports site monitoring, data listing reviews, and regulatory submissions within a leading healthcare company.

The ideal candidate has a life sciences background and up to 1 year CRA/CRC/CTA experience, familiarity with CFR/ICH-GCP, and strong teamwork and communication skills.

Qualifications

• BS degree in life sciences preferred with minimum 0-1 year CRA/CRC/CTA experience or combination of education and experience will be considered.
• Experience in conducting medical device studies and/or in-vitro diagnostics studies preferred.

Responsibilities

• Perform internal clinical studies, recruit study participants, conduct informed consent discussions with study volunteers, record study data, and maintain study files.
• Coordinate internal clinical studies from start to close-out.
• Perform study site visits (SQV, SIV, IMV, COV), generate monitoring reports, and track resolution of action items.
• Assist and conduct clinical monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements.
• Participate in study start up activities.
• Assist with shipping study devices and supplies to clinical sites.
• Perform study device accountability and reconciliation.
• Assist senior staff in development of study-specific forms and trial-specific monitoring plans.
• Assist senior staff in study planning, designing case report forms (CRFs), and training of study sites.
• Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.
• Perform review of clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/Study Lead as needed.
• Proactively and effectively communicate the status of clinical studies to management.
• Participate in the interim and final reviews of study data in preparation of regulatory submissions.
• May interact with RA/QA in responding to audits and FDA inquiries.
• Perform any other duties as assigned by management.

Skills

Teamwork

Interpersonal communication

Microsoft Office

Education

BS in life sciences

Job description

Abbott is seeking a Clinical Research Associate I to ensure quality and integrity of clinical trial data across multiple studies in Alameda, CA. This on-site role supports site monitoring, data listing reviews, and regulatory submissions within a leading healthcare company.

The ideal candidate has a life sciences background and up to 1 year CRA/CRC/CTA experience, familiarity with CFR/ICH-GCP, and strong teamwork and communication skills.