Clinical Trial Associate

Ardelyx•Newark, CA

1d•Onsite

About The Position

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 Trial Associate (CTA) supports the Clinical Trial Management team in the execution of assigned clinical trials, ensuring operational excellence, compliance with ICH-GCP and applicable regulatory requirements, and adherence to study timelines. The CTA contributes across all phases of the clinical trial lifecycle, from study start-up through close-out, and is responsible for the timely execution of study activities and deliverables in alignment with clinical development objectives and corporate goals.

Requirements

Bachelor’s degree in scientific or related field with 2+ years of experience in Clinical Operations, clinical research or healthcare, or equivalent experience
Working knowledge of the clinical trial lifecycle, from protocol development through study close-out
Familiarity with ICH-GCP guidelines, clinical protocols, and applicable regulatory requirements
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
Strong organizational skills with the ability to manage multiple priorities and maintain attention to detail in a fast-paced environment
Ability to work independently on routine assignments while exercising sound judgment and seeking guidance on more complex issues
Strong written and verbal communication skills, with demonstrated ability to collaborate effectively within cross-functional teams

Nice To Haves

Experience with clinical trial systems such as EDC, CTMS and eTMF platforms, preferred
Experience with Smartsheet or similar project management tools is a plus
Ability to travel as needed

Responsibilities

Provide operational support for assigned clinical trial(s) across all phases of the study lifecycle, including start-up, conduct and close-out activities
Assist Clinical Trial Managers (CTMs) and other senior team members with day-to-day study activities to ensure study milestones and timelines are achieved
Track and follow up on study action items through resolution, escalating issues as appropriate
Develop, maintain and reconcile study trackers including but not limited to protocol deviations, adverse events, site training, enrollment metrics, and key study milestones
Perform data verification and reconciliation of study trackers against EDC, CTMS, and other clinical systems to ensure data accuracy and completeness
Support CTMS and other clinical system activities, including data entry, quality and validation activities as required
Author, format, update, and route study documents, plans, templates and training materials for review and approval
Review quality check, upload, file, and reconcile documents to eTMF in accordance with regulatory guidance, internal SOPs and TMF Reference Model standards
Coordinate document review workflows, training distribution, and collection of required documentation from internal teams and sites
Prepare and maintain study agendas, meeting minutes, action item logs, and study status reports while facilitating effective communication across cross-functional teams and external stakeholders
Ensure study activities are conducted in compliance with ICH-GCP, applicable regulations, study protocols, and internal policies and procedures