CRA I: Site Monitoring for Medical Devices

Abbott

Alameda (CA)

On-site

USD 74,000 - 116,000

Full time

5 days ago

Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Abbott in Alameda, CA is hiring a Clinical Research Associate I for on-site duties. The role requires a BS in life sciences with at least 1 year in clinical research, preferably in medical devices or in vitro diagnostics. You will perform site visits, monitoring, TMF maintenance, and data reviews while ensuring regulatory compliance and quality across multiple trials.

Travel up to 50% is expected. The base pay range is $73,900–$116,000 annually, with Abbott offering comprehensive health and

Qualifications

BS degree in life sciences or equivalent with minimum one year clinical research experience.
Experience on medical device or in vitro diagnostics studies preferred.
Proficient with CFR, ICH-GCP, and regulatory affairs concepts.
Excellent teamwork and communication with site staff and management.

Responsibilities

Perform study site visits (SQV, SIV, IMV, COV) and generate monitoring reports.
Support clinical monitoring and site management per protocol, GCP, CFR guidelines.
Participate in study startup activities and device shipping to sites.
Maintain 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.
Travel up to 50% as required.