In House Clinical Research Associate
Ardelyx, Inc.
4 months ago
Remote friendly (Newark, CA)
United States
Clinical Research and Development
Position Summary
- The Clinical Research Associate (CRA) provides sponsor oversight of clinical trial execution focused on site performance, data quality, and regulatory compliance. Builds on prior CTA/similar experience to independently manage assigned sites and support study oversight.
Responsibilities
- Provide sponsor oversight of assigned investigative sites to ensure high-quality protocol execution and compliance with GCP and regulatory requirements
- Monitor site performance via centralized/remote review of study data, key metrics, and monitoring outputs; proactively identify and escalate issues with recommended mitigation
- Support study start-up, conduct, and close-out activities (site feasibility, activation, training, and close-out documentation)
- Ensure timely collection, review, and maintenance of essential regulatory documents and maintain Trial Master File (TMF) completeness, quality, and inspection readiness
- Partner with Clinical Trial Managers and CRO monitoring teams to ensure monitoring aligns with the study’s risk-based monitoring strategy
- Track and analyze protocol deviations, safety events, data discrepancies, and site performance trends; collaborate to drive timely resolution
- Support regulatory/inspection readiness by overseeing IRB/EC submissions and approvals, maintaining accurate site documentation, and assisting with audits/inspections
- Collaborate cross-functionally with Clinical Operations, Data Management, Safety, Regulatory Affairs, and Biostatistics; support sponsor oversight of CROs and others
- Participate in investigator meetings, study team meetings, and internal governance as required
Qualifications
- Bachelor’s degree in a relevant scientific discipline with 2–5 years of experience in clinical research, clinical operations, or healthcare-related roles (or equivalent)
- Prior experience as a Clinical Trial Assistant (CTA), Study Coordinator, or similar role required
- Working knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements
- Experience with sponsor systems: EDC, eTMF, CTMS, and centralized monitoring tools
- Strong analytical skills; ability to interpret study and site-level performance trends
- Excellent written and verbal communication skills; strong attention to detail
- Sponsor mindset focused on quality, accountability, and compliance
- Ability to work independently while escalating issues appropriately
- Strong problem-solving and proactive risk identification
- Effective collaboration and stakeholder management
- 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
- Annual Winter Holiday shut down and at least 11 paid holidays
- The Clinical Research Associate (CRA) provides sponsor oversight of clinical trial execution focused on site performance, data quality, and regulatory compliance. Builds on prior CTA/similar experience to independently manage assigned sites and support study oversight.
Responsibilities
- Provide sponsor oversight of assigned investigative sites to ensure high-quality protocol execution and compliance with GCP and regulatory requirements
- Monitor site performance via centralized/remote review of study data, key metrics, and monitoring outputs; proactively identify and escalate issues with recommended mitigation
- Support study start-up, conduct, and close-out activities (site feasibility, activation, training, and close-out documentation)
- Ensure timely collection, review, and maintenance of essential regulatory documents and maintain Trial Master File (TMF) completeness, quality, and inspection readiness
- Partner with Clinical Trial Managers and CRO monitoring teams to ensure monitoring aligns with the study’s risk-based monitoring strategy
- Track and analyze protocol deviations, safety events, data discrepancies, and site performance trends; collaborate to drive timely resolution
- Support regulatory/inspection readiness by overseeing IRB/EC submissions and approvals, maintaining accurate site documentation, and assisting with audits/inspections
- Collaborate cross-functionally with Clinical Operations, Data Management, Safety, Regulatory Affairs, and Biostatistics; support sponsor oversight of CROs and others
- Participate in investigator meetings, study team meetings, and internal governance as required
Qualifications
- Bachelor’s degree in a relevant scientific discipline with 2–5 years of experience in clinical research, clinical operations, or healthcare-related roles (or equivalent)
- Prior experience as a Clinical Trial Assistant (CTA), Study Coordinator, or similar role required
- Working knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements
- Experience with sponsor systems: EDC, eTMF, CTMS, and centralized monitoring tools
- Strong analytical skills; ability to interpret study and site-level performance trends
- Excellent written and verbal communication skills; strong attention to detail
- Sponsor mindset focused on quality, accountability, and compliance
- Ability to work independently while escalating issues appropriately
- Strong problem-solving and proactive risk identification
- Effective collaboration and stakeholder management
- 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
- Annual Winter Holiday shut down and at least 11 paid holidays