Clinical Research Associate I – Onsite Trial Support

Abbott; United States; On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Medical coverage

Retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott is seeking a Clinical Research Associate on-site in Alameda, California. You will ensure quality and integrity of clinical trial data across multiple trials, adhering to CFR, ICH‑GCP, and ISO14155, with travel up to 30-50% as needed.

Responsibilities include site visits, monitoring, and trial master file maintenance, supporting regulatory submissions, and collaboration with RA/QA. Requires 1+ year of clinical research and a life sciences background.

Qualifications

• BS degree in life sciences or equivalent with minimum one year of clinical research experience.
• Experience on medical device studies and/or in vitro diagnostics studies preferred.
• Demonstrate excellence in teamwork and communication; interact with site staff and management.
• Working knowledge of CFR, ICH‑GCP, Clinical and Regulatory Affairs.
• Proficient with Microsoft Suite.

Responsibilities

• 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, GCPs, ICH guidelines, Federal Regulations, department procedures, and other regulatory requirements.
• Participate in study start up activities.
• Assist with shipping study devices and supplies to clinical sites.
• Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.
• Proactively communicate study status to management and assist in data reviews for regulatory submissions.

Skills

Clinical research

GCP knowledge

Regulatory affairs familiarity

Education

BS degree in life sciences or equivalent

Tools

Microsoft Office

Job description

Abbott is seeking a Clinical Research Associate on-site in Alameda, California. You will ensure quality and integrity of clinical trial data across multiple trials, adhering to CFR, ICH‑GCP, and ISO14155, with travel up to 30-50% as needed.

Responsibilities include site visits, monitoring, and trial master file maintenance, supporting regulatory submissions, and collaboration with RA/QA. Requires 1+ year of clinical research and a life sciences background.