Job Title: Clinical Trial Associate
Location: Newark, California
Employment Type: Full-time
Company Overview:
Ardelyx is a publicly traded biopharmaceutical company focused on discovering, developing, and commercializing innovative first-in-class medicines that address significant unmet medical needs. The company has two commercially available products: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx is also involved in international partnerships for the development and commercialization of tenapanor.
Position Summary:
The Clinical Trial Associate (CTA) will support the Clinical Trial Management team in all operational aspects of assigned clinical trials, from study start-up to close-out. The CTA will help ensure efficient execution of tasks and timely completion of deliverables, contributing to the success of clinical trials and corporate objectives.
Key Responsibilities:
Study Management: Handle operational responsibilities throughout all stages of clinical trials, including study start-up and close-out.
Tracker Maintenance: Develop and maintain study-related trackers, including protocol deviations, adverse events, and training trackers.
Data Verification: Ensure accuracy in various trackers by comparing data from EDC and other systems.
Document Management: Facilitate document reviews, route training materials, and monitor study progress.
Authoring Documents: Author, update, format, and route study-related documents, training materials, plans, and templates for review and finalization.
Follow-up and Coordination: Follow up on outstanding action items and ensure resolution.
Meeting Coordination: Prepare and maintain agendas, minutes, and status updates for meetings as applicable.
Regulatory Compliance: Review and upload documents to the eTMF system and ensure adherence to regulatory guidelines and internal SOPs.
CTMS Validation: Perform CTMS and other system validations to ensure accuracy and compliance.
Qualifications:
Education: Bachelor's degree in a relevant scientific discipline.
Experience: 2+ years of experience in clinical operations or healthcare-related roles, or equivalent experience.
Skills:
Good understanding of clinical trial stages, from protocol design to study completion.
Ability to work independently and manage routine assignments effectively.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
Working knowledge of clinical protocols and ICH/GCP regulations.
Strong organizational skills, attention to detail, and the ability to manage multiple tasks.
Excellent communication skills, both oral and written.
Knowledge of Smartsheet is a plus.
Travel: Some travel may be required.
Compensation and Benefits:
Salary: $85,000 - $103,000 annually, based on experience and qualifications.
Bonus: Potential annual bonus.
Equity Awards: Eligibility for equity incentive plans.
Benefits:
401(k) with generous employer match.
12 weeks of paid parental leave.
Up to 12 weeks of living organ and bone marrow leave.
Health plans (medical, prescription, dental, vision).
Life insurance and disability coverage.
Flexible time off and paid holidays (11+ days).
Winter Holiday shutdown.
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