Clinical Research Associate I

Abbott Laboratories • Alameda, CA

63d • $73,900 - $116,000 • Onsite

About The Position

The Clinical Research Associate I ensures the quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials, in accordance with the Code of Federal Regulations, ICH GCP, and ISO 14155. This is an on-site position in Alameda, California, and is not remote. The role requires 30–50% travel, with additional travel as needed. The incumbent may also be assigned other function-related activities or duties by management.

Requirements

• Bachelor of Science degree in life sciences or equivalent, with at least one year of clinical research experience, or an appropriate combination of education and experience.
• Working knowledge of the Code of Federal Regulations (CFR), ICH-GCP, and Clinical and Regulatory Affairs.
• Proficiency with Microsoft Suite.
• Ability to travel 30–50%, with additional travel as required.

Nice To Haves

• Experience working on medical device studies and/or in-vitro diagnostics studies; pharmaceutical background may also be considered.
• Demonstrated excellence in teamwork and strong interpersonal and communication skills, including the ability to build rapport with team members, peers, study site staff, and clinical management.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Flexibility in daily activities.

Responsibilities

• Perform study site visits (SQV, SIV, IMV, and COV), generate monitoring reports, and track resolution of action items.
• Assist with and conduct clinical monitoring and site management activities, ensuring compliance with study protocols, GCP, 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.
• Perform study device accountability and reconciliation.
• Assist senior staff in developing study-specific forms and trial-specific monitoring plans.
• Assist senior staff with study planning, case report form (CRF) design, and training of study sites.
• Maintain and audit the Trial Master File (TMF), and upload documentation to the eTMF to ensure inspection readiness.
• Review clinical data listings for completeness and accuracy and escalate issues to the Clinical Operations Manager or Study Lead as needed.
• Communicate clinical study status proactively and effectively to management.
• Participate in interim and final study data reviews in preparation for regulatory submissions.
• May interact with Regulatory Affairs and Quality Assurance in responding to audits and FDA inquiries.
• Perform other duties as assigned by management.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage through the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, providing an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level