Clinical Research Assistant  

Make an impact in advancing clinical research that improves patient outcomes. In this role, you’ll support critical studies from start-up through close-out, ensuring accuracy and compliance every step of the way. If you’re energized by contributing to innovative medical research and thrive in a fast-paced environment, this is your opportunity to make a meaningful impact.

Work Flexibility: 

Hybrid: Candidates must reside within a commutable distance to Fremont, CA and be able to work onsite several times per week.

What you will do:

• Manage clinical documents and upload them into the Product Lifecycle Management (PLM) system.
• Track inventory and reconcile study and demo devices across sites.
• Create and maintain study trackers and lists; assist with mass mailings.
• Upload acquisitions into the Clinical Trial Management System (CTMS) and maintain Trial Master File (TMF) in inspection-ready state.
• Communicate with assigned sites to collect and review essential documents; perform quality control reviews and resolve issues.
• Support development and maintenance of study documents and templates to ensure data integrity and compliance with federal regulations and company policies.
• Distribute, collect, and track project-specific training documentation within established timelines.
• Manage SharePoint access and assist with site binder and material distributions.

What you will need:

Required Qualifications:

• Bachelor’s degree

Preferred Qualifications:

• Fundamental knowledge of Good Clinical Practices (GCP), clinical study development processes, and logistics.
• Knowledge of clinical and regulatory affairs.
• Experience in a related field (e.g., medical or research) and familiarity with medical terminology.
• Licensed/certified healthcare training 

$89,800.00 - $139,600.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.