Clinical data associate • fremont ca
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 medic...[internal_linking.show_more]
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To be eligible for this position, you must reside in the same country where the job is located.Perform monitoring and site management work to ensure that sites are conducting the study(ies) and rep...[internal_linking.show_more]
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To be eligible for this position, you must reside in the same country where the job is located.Perform monitoring and site management work to ensure that sites are conducting the study(ies) and rep...[internal_linking.show_more]
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Clinical Data Coordinator Job Duties: Support laboratory data management procedures including authoring and reviewing data transfer plans, overseeing data transfers, processing and storage of data....[internal_linking.show_more]
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:
