In House Clinical Research Associate

Ardelyx

Newark, CA

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JOB DETAILS

SALARY

$99,000–$121,000 Per Year

JOB TYPE

Full-time

SKILLS

Analysis Skills, Biostatistics, Building Regulations, Clinical Data Management, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Quality, Documentation, Electronic Data Capture (EDC), Employee Benefits, FDA Requirements, Field Trials, File Maintenance, GCP (Good Clinical Practices), Health Plan, Healthcare, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Identify Issues, Incentive Programs, Insurance, Operations Management, Operations Research, Organizational Skills, Performance Analysis, Performance Metrics, Prescription Drugs, Presentation/Verbal Skills, Problem Solving Skills, Protocol Analysis, Regulations, Regulatory Compliance, Risk Analysis, Risk Management, Startup, Team Player, Time Management, Willing to Travel, Writing Skills

LOCATION

Newark, CA

POSTED

27 days ago

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.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 requirementsMonitor 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 strategiesSupport study start-up, conduct, and close-out activities, including site feasibility, activation, training, and close-out documentationEnsure timely collection, review, and maintenance of essential regulatory documents and maintain Trial Master File (TMF) completeness, quality and inspection readinessPartner with Clinical Trial Managers and CRO monitoring teams to provide sponsor oversight and ensure monitoring activities align with the study’s risk-based monitoring strategyTrack and analyze protocol deviations, safety events, data discrepancies, and site performance trends; collaborate with cross-functional teams to drive timely resolutionSupport 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 activitiesCollaborate cross-functionally with Clinical Operations, Data Management, Safety, Regulatory Affairs, and Biostatistics, and support sponsor oversight of CROs and otherParticipate in investigator meetings, study team meetings, and internal governance as requiredQualifications: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 experiencePrior experience as a Clinical Trial Assistant (CTA), Study Coordinator, or similar clinical research role requiredWorking knowledge of ICH-GCP, FDA regulations, and global clinical trial requirementsExperience with sponsor systems EDC, eTMF, CTMS and centralized monitoring toolsStrong analytical skills with the ability to interpret study and site-level performance trendsExcellent written and verbal communication skills with high level of attention to detailDemonstrated sponsor mindset with a focus on quality, accountability, and complianceAbility to work independently while escalating issues appropriatelyStrong problem abilities and proactive risk identification skillsEffective collaboration and stakeholder management abilitiesThrives in a collaborative environment and enjoys working cross-functionally to solve operational challenges.Ability to travel as neededThe 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.

About the Company

Ardelyx

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