Senior Clinical Research Associate

Overview

The Senior Clinical Research Associate is responsible for clinical site management and monitoring activities to ensure adherence to study protocols, GCP guidelines, and applicable regulations. This role performs on-site and remote monitoring, reviews monitoring reports and site data for quality and trends, supports issue identification and resolution at the site level, and collaborates closely with the clinical study team. The Senior CRA may mentor junior CRAs, sharing best practices to support high-quality monitoring and successful execution of clinical trials.

Reports to: Director, Clinical Operations

Location: Redwood City, CA (Hybrid)

• Perform on-site and remote monitoring visits for assigned sites in accordance with the Clinical Monitoring Plan, ICH GCP guidelines, and applicable local regulations.
• Conduct source data verification to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documents and the protocol.
• Manage day-to-day communication with assigned sites, supporting enrollment, query resolution, and overall site performance.
• Proactively identify and document site-level risks and issues, respond to study-specific questions, and manage escalations through to resolution.
• Oversee the collection, review, and maintenance of essential regulatory and study documents to ensure inspection readiness.
• Collaborate closely with investigators and internal clinical teams to support effective study start-up, conduct, and close-out, and to ensure successful trial execution.
• Oversee the execution of clinical trial activities in accordance with Good Clinical Practices.

• bachelor's degree in a life sciences or health-related field.
• 5+ years of clinical trial experience to include study monitoring; experience with LDTs or in vitro diagnostic devices strongly preferred. 3+ years experience with a master's degree.
• Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.
• Ability to travel frequently, sometimes on short notice, and manage travel logistics effectively.
• Proficiency in Microsoft Office and clinical trial management systems (CTMS) preferred.