Clinical Research Associate/Senior Clinical Research Associate

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Manage site management, site monitoring and close-out of assigned clinical trial investigator sites • Ensure patient safety and quality study execution in accordance with applicable laws, GCP and sponsor standards • Manage investigator site relationships and resolve protocol-related issues • Manage clinical trial activities from site activation through database lock • Serve as primary contact for assigned investigator sites • Coordinate with Site Care Partners, study teams, vendors and investigator sites • Coach and train site personnel on protocols and compliance • Support site activation, patient recruitment and enrollment • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and site closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment and study progress reports • Identify and resolve site issues and develop corrective and preventive actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, storage, accounting and destruction • Support database release and perform unblinded monitoring where appropriate • Maintain product, protocol and therapy-area knowledge • Support patient safety, eligibility and clinical guidance • Drive Quality Event remediation and audit CAPA activities when applicable

🎯 Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations • Minimum 2 years relevant experience in clinical research site monitoring • Must be fluent in English and in the native language(s) of the country they will work in • Ability to travel 60-80% • Valid driver’s license and passport required • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

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