Clinical Research, Associate I

Abbott • Alameda, CA

2d • Onsite

About The Position

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.

Requirements

• BS degree in life sciences preferred with minimum 0-1 year CRA/CRC/CTA experience; or combination of some education and minimum 2 yrs experience will be considered.
• Experience in conducting medical device studies and/or in-vitro diagnostics studies preferred.
• Pharmaceutical background may also be considered.
• 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

Responsibilities

• Perform internal clinical studies, recruit study participants, conduct informed consent discussions with study volunteers, record study data, and maintain study files.
• Coordinate internal clinical studies from start to close-out.
• 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.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement
• the Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

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