In House Clinical Research Associate

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.

Position Summary

The Clinical Research Associate (CRA) supports sponsor oversight of clinical trial execution with an focus on site performance, data quality, and regulatory compliance. Building on prior experience in a Clinical Trial Assistant (CTA) or similar role, the CRA II independently manages assigned sites and supports study oversight of clinical trial execution. This role partners closely with Clinical Trial Managers, Field CRAs, vendors, and cross-functional stakeholders to ensure trials are conducted in accordance with ICH-GCP, applicable regulations, and internal governance standards. The CRA II contributes to proactive risk identification, issue resolution and continuous inspection readiness.

Responsibilities

• Provide sponsor oversight of assigned investigative sites, serving as the primary operational and ensuring high – quality protocol execution, and compliance with GCP, and regulatory requirements
• Monitor site performance through centralized and remote review of study data, key performance metrics, and monitoring outputs, including proactively identify and escalate issues with recommended mitigation strategies
• Support study start-up, conduct, and close-out activities, including site feasibility, activation, training, and close-out documentation
• Ensure timely collection, review, and maintenance of essential regulatory documents and maintain Trial Master File (TMF) completeness, quality and inspection readiness
• Partner with Clinical Trial Managers and CRO monitoring teams to provide sponsor oversight and ensure monitoring activities align with the study’s risk-based monitoring strategy
• Track and analyze protocol deviations, safety events, data discrepancies, and site performance trends; collaborate with cross-functional teams to drive timely resolution
• Support regulatory and inspection readiness by overseeing IRB/EC submissions and approvals, maintaining accurate site documentation, and contributing to audit and inspection preparation, responses, and follow-up activities