Clinical Trial Associate
Location: Newark, California
Department: Clinical
Company Overview:
Ardelyx is a publicly traded biopharmaceutical company committed to discovering, developing, and commercializing first-in-class medicines to address significant unmet medical needs. The company currently markets IBSRELA® and XPHOZAH® in the U.S., with international agreements including PHOZEVEL® (Japan), tenapanor (China with Fosun Pharma), and IBSRELA (Canada with Knight Therapeutics).
Position Summary:
The Clinical Trial Associate (CTA) will support the Clinical Trial Management team in the efficient execution of clinical studies from initiation to closure. This role ensures study deliverables are met in alignment with team goals and company objectives.
Key Responsibilities:
Manage operational aspects of assigned clinical trials from start-up through close-out.
Develop and maintain study trackers (protocol deviations, adverse events, training, etc.).
Perform data verification across EDC and internal systems for consistency.
Facilitate review processes, document routing, and tracking of training materials.
Author and format study documents, plans, templates, and training content.
Maintain meeting agendas, minutes, and follow up on outstanding items.
Upload, QC, and reconcile documents in the eTMF per regulatory and SOP standards.
Ensure procedural compliance and identify/implement corrective actions when deviations occur.
Validate data entries in CTMS and related systems as necessary.
Qualifications:
Bachelor’s degree in a scientific discipline or related healthcare field.
Minimum 2 years of clinical operations or equivalent healthcare-related experience.
Understanding of clinical trial phases and operations from protocol to study completion.
Ability to work independently on routine tasks and collaboratively on new projects.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Familiarity with clinical protocols and ICH/GCP guidelines.
Strong organizational skills with high attention to detail and task management.
Effective communication skills—both written and verbal.
Experience with Smartsheet is a plus.
Travel may be required.
Compensation & Benefits:
Salary Range: $85,000–$103,000 annually (based on experience, training, qualifications, and internal equity).
Incentives: Eligibility for annual bonus and equity awards.
Benefits Include:
401(k) with employer match
12 weeks paid parental leave
12 weeks of living organ/bone marrow leave
Health, dental, vision, life, and disability insurance
Flexible time off & 11+ paid holidays
Annual Winter Holiday shutdown
Equity incentive plans
Ardelyx is proud to be an Equal Opportunity Employer.
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