Clinical Research Associate II Abbott Laboratories San Francisco
Overview
Abbott seeks a Clinical Research Associate II to lead quality assurance in clinical trials at our Alameda location. You will ensure data integrity across the full trial lifecycle while collaborating with cross‑functional teams to drive operational excellence. This role offers a chance to impact patient outcomes through rigorous scientific practices.
What You'll Do11
- 1Perform internal clinical studies and coordinate site activities from start to close‑out
- 2Conduct informed consent discussions and record study data accurately
- 3Generate monitoring reports and track resolution of action items
- 4Assist in site setup, device shipping, and supply reconciliation
- 5Develop study‑specific forms and monitoring plans under senior staff guidance
- 6Maintain and audit Trial Master Files within eTMF systems
- 7Review clinical data listings for completeness and escalate findings to leadership
- 8Communicate study status to management and participate in interim/final reviews
- 9Support regulatory submissions by preparing data listings
- 10Collaborate with RAs/QA during audits and FDA inquiries
- 11Apply knowledge of CFR and ICH‑GCP to all study activities
Requirements6
- 1BS degree in life sciences or related field with minimum 2 years as a CRA CRC CTA
- 25+ years of experience in clinical research or medical device studies
- 3Preference for experience with in‑vitro diagnostics studies
- 4Pharmaceutical background is advantageous
- 5Strong teamwork and communication skills demonstrated through past interactions
- 6Proficiency with Microsoft Office suite required
Salary Insight
$82 - $141k per year
Location
Required Skills
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