Senior Clinical Trial Associate

We are partnered with a well-funded, clinical-stage Immuno-Oncology biotech in the San Francisco Bay Area that is advancing innovative therapies in oncology. As the organization continues to expand its clinical pipeline, they are seeking a Senior Clinical Trial Associate or Clinical Trial Associate to support the execution of global clinical studies.

The Senior CTA/CTA will play a critical role in supporting the planning, startup, and execution of clinical trials. This individual will work cross-functionally with Clinical Operations, Regulatory, Data Management, and external vendors to ensure studies are initiated and maintained in compliance with regulatory requirements and internal standards.

This is an in-house role offering strong visibility and growth within a rapidly expanding clinical team.

• Support the development and review of clinical trial documents including protocols, informed consent forms (ICFs), and other essential study materials
• Coordinate cross-functional activities to ensure efficient study startup and trial execution
• Prepare, review, and submit regulatory documentation to IRBs/ECs and regulatory authorities
• Maintain trial master file (TMF) documentation and ensure inspection readiness
• Track study milestones, timelines, and deliverables to support on-time execution
• Ensure compliance with ICH-GCP, FDA, and other applicable regulatory requirements
• Collaborate with CROs, vendors, and study sites as needed
• Assist with study reporting and documentation management

• Bachelor’s degree in life sciences or related field required
• 2–5+ years of clinical research experience for CTA; 4–7+ years for Senior CTA
• Prior in-house clinical operations experience strongly preferred
• Experience in Immuno-Oncology or oncology trials preferred
• Strong knowledge of ICH-GCP and regulatory submission processes
• Excellent organizational skills and ability to manage multiple priorities
• Strong written and verbal communication skills