Clinical Research Associate I at Abbott Alameda, CA

Abbott; Alameda (CA); On-site; USD 72,100 - 114,700; Full time

Job summary

Abbott in Alameda, CA is seeking a Clinical Research Associate I to ensure data integrity in clinical trials. This role involves conducting site visits, assisting with study management, and ensuring compliance with regulations.

The ideal candidate holds a BS in life sciences and has at least one year of clinical research experience. Strong interpersonal skills and teamwork are essential. The position offers a salary range of $72,100 to $114,700.

Qualifications

• Minimum one year of clinical research experience or equivalent education.
• Experience with medical device studies or in-vitro diagnostics preferred.
• Strong communication skills for rapport building.

Responsibilities

• Ensure quality and accuracy of clinical trial data.
• Perform study site visits and generate monitoring reports.
• Assist in clinical monitoring and site management activities.
• Maintain and audit Trial Master File.

Skills

Clinical research experience

Teamwork

Interpersonal communication skills

CFR knowledge

ICH-GCP knowledge

Microsoft Suite proficiency

Education

BS degree in life sciences

Job description

Clinical Research Associate I job at Abbott. Alameda, CA. Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. The Opportunity The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155. This is an on-site position in Alameda, California. This is not a remote position. What You Will Work On

• 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.
• Perform study device accountability and reconciliation.
• Assist senior staff in development of study-specific forms and trial-specific monitoring plans.
• Assist senior staff in study planning, designing case report forms (CRFs), and training of study sites.
• Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.
• Perform review of clinical data listings for completeness and accuracy; and 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.
• Must be able to travel 30-50%-, with additional travel as required.

Required Qualifications

• BS degree in life sciences preferred or equivalent with minimum one (1) year of clinical research experience, or combination of appropriate education and experience.
• Experience working on medical device studies and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered.
• Perform any other duties as assigned by management.
• 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
• Proficient with Microsoft Suite

The base pay for this position is $72,100.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.