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.
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
Qualifications: - 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
- Experience with clinical trial systems such as EDC, CTMS and eTMF platforms, preferred
- 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
- Experience with Smartsheet or similar project management tools is a plus
- Ability to travel as needed
The anticipated annualized base pay range for this full-time position is $86,000 - $105,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
