Associate I Clinical Research

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'll 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.
• 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.

Preferred Qualifications

• Experience working on 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.
• Proficient with Microsoft Suite.
• Flexibility in daily activities.