CRA II, Medical Devices Trials - Global Impact

Regulatory Jobs; Alameda (CA); On-site; USD 82,000 - 141,000; Full time

Benefits offered by this job

Career development

HIP PPO health coverage

Retirement plan

Tuition reimbursement

FreeU education benefit

Awards and recognition

Job summary

Abbott is seeking a Clinical Research Associate II to support clinical execution and management of assigned studies. This role is based in Alameda, CA, and involves site monitoring, study start-up, data review, and regulatory submissions to uphold timelines and quality.

You will travel 30-50% and work with cross-functional teams to ensure TMF readiness and regulatory compliance, with opportunities for career development and Abbott’s extensive benefits.

Qualifications

• B.S. degree in life sciences or equivalent; 5+ years clinical research experience.
• 2+ years of site monitoring experience.
• Experience in medical device and/or in-vitro diagnostics studies; pharma background acceptable.
• Willingness to travel 30–50%.

Responsibilities

• Conduct single or multicenter medical device clinical studies.
• Perform study site visits (SQV, SIV, IMV, COV) and monitor action items.
• Participate in study start-up activities.
• Responsible for shipping study devices and supplies to sites; device accountability.
• Manage monitoring activities and site management per protocol and GCP/ICH regulations.
• Assist senior staff in planning conduct, CRF design, UAT, CRO selection and training.
• Maintain and audit Trial Master File for inspection readiness.
• Review clinical data listings for completeness and escalate issues.
• Participate in cross-functional clinical teams for trial planning/execution.
• Communicate status of studies to management; ensure timely deliverables.

Skills

Clinical research

GCP knowledge

Site monitoring

Project management

Communication

MS Office

Education

B.S. degree in life sciences or equivalent

Tools

Microsoft Office Suite

Job description

Abbott is seeking a Clinical Research Associate II to support clinical execution and management of assigned studies. This role is based in Alameda, CA, and involves site monitoring, study start-up, data review, and regulatory submissions to uphold timelines and quality.

You will travel 30-50% and work with cross-functional teams to ensure TMF readiness and regulatory compliance, with opportunities for career development and Abbott’s extensive benefits.