Clinical Trial Associate
Ardelyx, Inc.
June 26, 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 start-up, conduct, and close-out.
- Assist Clinical Trial Managers (CTMs) and senior team members with day-to-day study activities to meet milestones and timelines.
- Track and follow up on study action items, escalating issues as appropriate.
- Develop, maintain, and reconcile study trackers (e.g., protocol deviations, adverse events, site training, enrollment metrics, key milestones).
- Verify and reconcile study tracker data against EDC, CTMS, and other clinical systems for accuracy and completeness.
- Support CTMS/clinical system activities (data entry, quality and validation as required).
- Author, format, update, and route study documents, plans, templates, and training materials for review/approval.
- Review, upload, file, and reconcile documents to eTMF per regulatory guidance, SOPs, and TMF Reference Model standards.
- Coordinate document review workflows and training distribution/collection from internal teams and sites.
- Prepare and maintain study agendas, meeting minutes, action item logs, and status reports.
- Support health authority inspection readiness by providing requested documents.
- Ensure study activities comply with ICH-GCP, regulations, protocols, and internal policies.
Qualifications
- Bachelor’s degree in scientific/related field with 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 regulatory requirements.
- Experience with EDC, CTMS, and eTMF platforms (preferred).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Strong organization; ability to manage multiple priorities and detail orientation.
- Ability to work independently on routine assignments and seek guidance on complex issues.
- Strong written/verbal communication; cross-functional collaboration.
- Smartsheet (or similar project management) experience (plus).
- Ability to travel as needed.
Benefits
- 401(k) with employer match; paid parental leave (12 weeks); living organ/bone marrow leave (up to 12 weeks); equity incentive plans; health plans (medical, prescription drug, dental, vision); life insurance and disability; flexible time off; annual Winter Holiday shut down; at least 11 paid holidays.
Application Instructions
Not specified.
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 start-up, conduct, and close-out.
- Assist Clinical Trial Managers (CTMs) and senior team members with day-to-day study activities to meet milestones and timelines.
- Track and follow up on study action items, escalating issues as appropriate.
- Develop, maintain, and reconcile study trackers (e.g., protocol deviations, adverse events, site training, enrollment metrics, key milestones).
- Verify and reconcile study tracker data against EDC, CTMS, and other clinical systems for accuracy and completeness.
- Support CTMS/clinical system activities (data entry, quality and validation as required).
- Author, format, update, and route study documents, plans, templates, and training materials for review/approval.
- Review, upload, file, and reconcile documents to eTMF per regulatory guidance, SOPs, and TMF Reference Model standards.
- Coordinate document review workflows and training distribution/collection from internal teams and sites.
- Prepare and maintain study agendas, meeting minutes, action item logs, and status reports.
- Support health authority inspection readiness by providing requested documents.
- Ensure study activities comply with ICH-GCP, regulations, protocols, and internal policies.
Qualifications
- Bachelor’s degree in scientific/related field with 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 regulatory requirements.
- Experience with EDC, CTMS, and eTMF platforms (preferred).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Strong organization; ability to manage multiple priorities and detail orientation.
- Ability to work independently on routine assignments and seek guidance on complex issues.
- Strong written/verbal communication; cross-functional collaboration.
- Smartsheet (or similar project management) experience (plus).
- Ability to travel as needed.
Benefits
- 401(k) with employer match; paid parental leave (12 weeks); living organ/bone marrow leave (up to 12 weeks); equity incentive plans; health plans (medical, prescription drug, dental, vision); life insurance and disability; flexible time off; annual Winter Holiday shut down; at least 11 paid holidays.
Application Instructions
Not specified.