Clinical Trial Associate
Ardelyx, Inc.
August 07, 2026
Remote friendly (Newark, CA)
United States
Clinical Research and Development
Position Summary:
The Clinical Trial Associate (CTA) supports the Clinical Trial Management team in executing assigned clinical trials, ensuring operational excellence, compliance with ICH-GCP and applicable regulatory requirements, and adherence to study timelines.
Responsibilities:
- Provide operational support for assigned clinical trial(s) across the study lifecycle (start-up, conduct, close-out)
- Assist Clinical Trial Managers (CTMs) and senior team members with day-to-day study activities to achieve milestones and timelines
- Track and follow up on study action items; escalate issues as appropriate
- Develop, maintain, and reconcile study trackers (protocol deviations, adverse events, site training, enrollment metrics, key milestones)
- Verify and reconcile tracker data against EDC, CTMS, and other clinical systems for accuracy and completeness
- Support CTMS and other clinical systems (data entry, quality/validation activities as required)
- Author, format, update, and route study documents, plans, templates, and training materials for approval
- Review, upload, file, and reconcile documents to eTMF per regulatory guidance, internal SOPs, and TMF Reference Model standards
- Coordinate document review workflows and training documentation collection/distribution
- Prepare study agendas, meeting minutes, action item logs, and status reports; facilitate communication across teams and stakeholders
- Support health authority inspection readiness by providing requested documents
- Ensure study activities are conducted per ICH-GCP, study protocols, and internal policies/procedures
Qualifications:
- Bachelor’s degree in scientific/related field and 2+ years’ experience in Clinical Operations, clinical research, or healthcare (or equivalent)
- Working knowledge of the clinical trial lifecycle (protocol development through close-out)
- Familiarity with ICH-GCP, clinical trial documents, and applicable regulatory requirements
- Experience with EDC, CTMS, and eTMF platforms (preferred)
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Strong organizational skills; manage multiple priorities and detail in a fast-paced environment
- Ability to work independently and seek guidance on complex issues
- Strong written/verbal communication and cross-functional collaboration
- Smartsheet or similar project management tools (plus)
- Ability to travel as needed
Benefits:
- 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; equity incentive plans
- Health plans (medical, prescription drug, dental, vision); life insurance and disability; flexible time off; Winter Holiday shut down; at least 11 paid holidays
Pay Range:
- Anticipated annualized base pay: $86,000 - $105,000
Application instructions:
Not provided.
The Clinical Trial Associate (CTA) supports the Clinical Trial Management team in executing assigned clinical trials, ensuring operational excellence, compliance with ICH-GCP and applicable regulatory requirements, and adherence to study timelines.
Responsibilities:
- Provide operational support for assigned clinical trial(s) across the study lifecycle (start-up, conduct, close-out)
- Assist Clinical Trial Managers (CTMs) and senior team members with day-to-day study activities to achieve milestones and timelines
- Track and follow up on study action items; escalate issues as appropriate
- Develop, maintain, and reconcile study trackers (protocol deviations, adverse events, site training, enrollment metrics, key milestones)
- Verify and reconcile tracker data against EDC, CTMS, and other clinical systems for accuracy and completeness
- Support CTMS and other clinical systems (data entry, quality/validation activities as required)
- Author, format, update, and route study documents, plans, templates, and training materials for approval
- Review, upload, file, and reconcile documents to eTMF per regulatory guidance, internal SOPs, and TMF Reference Model standards
- Coordinate document review workflows and training documentation collection/distribution
- Prepare study agendas, meeting minutes, action item logs, and status reports; facilitate communication across teams and stakeholders
- Support health authority inspection readiness by providing requested documents
- Ensure study activities are conducted per ICH-GCP, study protocols, and internal policies/procedures
Qualifications:
- Bachelor’s degree in scientific/related field and 2+ years’ experience in Clinical Operations, clinical research, or healthcare (or equivalent)
- Working knowledge of the clinical trial lifecycle (protocol development through close-out)
- Familiarity with ICH-GCP, clinical trial documents, and applicable regulatory requirements
- Experience with EDC, CTMS, and eTMF platforms (preferred)
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Strong organizational skills; manage multiple priorities and detail in a fast-paced environment
- Ability to work independently and seek guidance on complex issues
- Strong written/verbal communication and cross-functional collaboration
- Smartsheet or similar project management tools (plus)
- Ability to travel as needed
Benefits:
- 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; equity incentive plans
- Health plans (medical, prescription drug, dental, vision); life insurance and disability; flexible time off; Winter Holiday shut down; at least 11 paid holidays
Pay Range:
- Anticipated annualized base pay: $86,000 - $105,000
Application instructions:
Not provided.