Clinical Research Associate

About the role

The Clinical Research Associate I position at Abbott involves ensuring the quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to regulatory standards. This is an on-site position in Alameda, California.

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, 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.
• Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.
• Review clinical data listings for completeness and accuracy; 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.

Requirements

• BS degree in life sciences preferred or equivalent with minimum 2 years of CRA/CRC/CTA experience, or combination of appropriate education and experience.
• Experience working on medical device studies and/or in-vitro diagnostics studies preferred.
• Demonstrate excellence in teamwork, solid interpersonal and communication skills including building rapport with team members/peers, study site staff, and clinical management.
• Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs.
• Flexibility in daily activities.
• Proficient with Microsoft Suite.

Qualifications

• Must be able to travel 30-40%, with additional travel as required.

Skills

• Strong organizational and time management skills.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Knowledge of clinical research protocols and regulations.

Benefits

• Free medical coverage via the Health Investment Plan (HIP) PPO.
• Adequate retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
• Company recognized as a great place to work in dozens of countries.
• Recognized as one of the best big companies to work for and a best place to work for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.

Schedule

This is an on-site position in Alameda, California. This is not a remote position.