Clinical Research Assistant

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. Apply tot his job