In House Clinical Research Associate

In House Clinical Research Associate Waltham, MA Job Details Full-time $99,000 - $121,000 a year 13 hours ago Benefits Paid parental leave Paid holidays Health insurance Dental insurance Parental leave Vision insurance 401(k) matching Life insurance Qualifications Regulatory inspections Stakeholder engagement Clinical research Research Mid-level Risk mitigation strategy implementation Data quality management Key Performance Indicators Analysis skills ICH guidelines Bachelor's degree Research compliance clinical trial records management Good Clinical Practice Regulatory submissions Research regulatory compliance IRB compliance Cross-functional collaboration Escalation handling 2 years Communication skills Stakeholder relationship building Cross-functional communication FDA regulations Analytics Stakeholder management Full Job Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes

PHOZEVEL

® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

Position Summary:

The Clinical Research Associate (CRA) supports sponsor oversight of clinical trial execution with an focus on site performance, data quality, and regulatory compliance. Building on prior experience in a Clinical Trial Assistant (CTA) or similar role, the CRA II independently manages assigned sites and supports study oversight of clinical trial execution. This role partners closely with Clinical Trial Managers, Field CRAs, vendors, and cross-functional stakeholders to ensure trials are conducted in accordance with ICH-GCP, applicable regulations, and internal governance standards. The CRA II contributes to proactive risk identification, issue resolution and continuous inspection readiness.

Responsibilities:

Provide sponsor oversight of assigned investigative sites, serving as the primary operational and ensuring high - quality protocol execution, and compliance with GCP, and regulatory requirements Monitor site performance through centralized and remote review of study data, key performance metrics, and monitoring outputs, including proactively identify and escalate issues with recommended mitigation strategies Support study start-up, conduct, and close-out activities, including 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 provide sponsor oversight and ensure monitoring activities align with the study's risk-based monitoring strategy Track and analyze protocol deviations, safety events, data discrepancies, and site performance trends; collaborate with cross-functional teams to drive timely resolution Support regulatory and inspection readiness by overseeing IRB/EC submissions and approvals, maintaining accurate site documentation, and contributing to audit and inspection preparation, responses, and follow-up activities Collaborate cross-functionally with Clinical Operations, Data Management, Safety, Regulatory Affairs, and Biostatistics, and support sponsor oversight of CROs and other Participate in investigator meetings, study team meetings, and internal governance as required

Qualifications:

Bachelor's degree in relevant scientific discipline with 2-5 years of experience in clinical research, clinical operations or healthcare-related roles or equivalent combination of education and experience Prior experience as a Clinical Trial Assistant (CTA), Study Coordinator, or similar clinical research 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 with the ability to interpret study and site-level performance trends Excellent written and verbal communication skills with high level of attention to detail Demonstrated sponsor mindset with a focus on quality, accountability, and compliance Ability to work independently while escalating issues appropriately Strong problem abilities and proactive risk identification skills Effective collaboration and stakeholder management abilities Thrives in a collaborative environment and enjoys working cross-functionally to solve operational challenges. Ability to travel as needed The anticipated annualized base pay range for this full-time position is $99,000 - $121,000. 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. Ardelyx is an equal opportunity employer.