Clinical Research Associate

Duties and Responsibilities Manage day-to-day operational execution of assigned clinical studies to achieve study milestones, quality expectations, and budget objectives. May lead cross-functional study team activities and coordinate operational deliverables across internal stakeholders and external vendors. Oversee CROs and study vendors to ensure timely delivery, issue resolution, quality performance, and compliance with study requirements. Support study start-up activities, including feasibility assessments, country and site selection, vendor selection, system set-up, and user acceptance testing. Develop and maintain study management plans, operational timelines, and study tracking tools to support effective trial execution. Ensure inspection readiness and maintain Trial Master File documentation in compliance with ICH/GCP guidelines and company SOPs. Monitor study progress, identify operational risks, and implement mitigation plans to address issues impacting quality, timelines, or budget. Contribute to data review, data cleaning activities, and operational review of study outputs and clinical study documentation. Prepare and review study-related materials, including training content, operational manuals, presentations, and status reports. Review study invoices, support accrual tracking activities, and monitor study spend against approved budgets. Requirements and Qualifications Typically requires a bachelor's degree in life sciences, nursing, health sciences, or a related field; advanced degree, RN, or PA credentials preferred. Typically requires 5+ years of clinical research or pharmaceutical industry experience, including 2+ years of clinical trial management experience. Experience managing global or multi-site clinical studies within a sponsor or CRO environment preferred. Working knowledge of ICH/GCP guidelines, FDA regulations, and clinical trial processes across study start-up, conduct, and closeout. Demonstrated ability to manage multiple priorities, solve operational issues, and drive projects independently in a fast-paced environment. Strong organizational, communication, and cross-functional collaboration skills. Proficiency with clinical trial systems, study tracking tools, and vendor management processes. Desired Skills and Experience Clinical Research, Clinical Trial Management, Clinical Study Operations, Global Clinical Studies, Multi-Site Clinical Trials, Study Start-Up, Feasibility Assessments, Country Selection, Site Selection, Vendor Selection, CRO Oversight, Vendor Management, Cross-Functional Collaboration, Study Team Leadership, Study Management Plans, Operational Timelines, Study Tracking Tools, Clinical Trial Systems, User Acceptance Testing, Trial Master File, Inspection Readiness, ICH/GCP, FDA Regulations, SOP Compliance, Risk Mitigation, Data Review, Data Cleaning, Clinical Study Documentation, Training Materials, Operational Manuals, Status Reporting, Budget Tracking, Accrual Tracking, Invoice Review, Study Spend Monitoring, Life Sciences, Pharmaceutical Industry, Sponsor Environment, CRO Environment #J-18808-Ljbffr