Clinical Trial Associate
Company: Ardelyx
Location: Newark, California
Employment Type: Full-Time
Company Overview:
Ardelyx is a publicly traded biopharmaceutical company committed to developing and commercializing innovative, first-in-class medicines for patients with unmet medical needs. With FDA-approved products like IBSRELA® and XPHOZAH® in the U.S., Ardelyx continues to expand its global reach through strategic partnerships in Japan, China, and Canada.
Position Summary:
The Clinical Trial Associate (CTA) will support clinical trial operations from initiation to close-out. Working alongside senior clinical trial managers, the CTA will assist in tracking study progress, managing documents, maintaining data accuracy, and ensuring compliance with internal procedures and regulatory standards.
Key Responsibilities:
Manage various operational aspects of clinical trials throughout the study lifecycle.
Create and maintain trackers for protocol deviations, adverse events, and site training records.
Perform data checks across trackers, EDC systems, and other platforms to ensure accuracy.
Facilitate document review, training material distribution, and monitor trial progress.
Draft, format, and route study documents, templates, and training plans for approval.
Follow up on open items and unresolved issues to ensure timely completion.
Prepare meeting agendas, minutes, and study status reports.
Upload and QC documents in the eTMF, maintaining compliance with SOPs and regulatory standards.
Conduct CTMS and system validations to confirm accuracy, if required.
Identify and address deviations from SOPs or work instructions.
Qualifications:
Bachelor’s degree in a scientific field or equivalent healthcare/clinical operations experience.
Minimum of 2 years’ experience in clinical operations or a related healthcare role.
Strong understanding of clinical trial phases and regulatory requirements.
Independent worker on routine tasks; ability to take direction on novel assignments.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Familiarity with clinical protocols and ICH/GCP guidelines.
Strong attention to detail, organizational skills, and multitasking ability.
Effective written and verbal communication skills.
Team-oriented with excellent collaboration capabilities.
Knowledge of Smartsheet is a plus.
Willingness to travel if necessary.
Compensation & Benefits:
Annual base salary range: $85,000–$103,000 (based on experience, training, and qualifications).
Eligible for annual bonus and equity awards.
Comprehensive benefits package including:
401(k) plan with employer match
12 weeks paid parental leave
Up to 12 weeks living organ and bone marrow leave
Health, dental, vision, life, and disability insurance
Flexible time off and 11+ paid holidays
Annual winter holiday shutdown
Equity incentive plans
Equal Opportunity Statement:
Ardelyx is an equal opportunity employer and is committed to fostering an inclusive workplace. All qualified applicants will be considered without regard to race, gender, age, disability, religion, veteran status, or other protected categories.
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