Senior Clinical Research Associate

🔥 1 minute ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs. • Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely. • Partner with Clinical Trial Liaison (CTL) and other client functions to support site activation and deliverables. • Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct. • Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements. • Prepare and maintain Oversight Monitoring Plan. • Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA. • Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting. • Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary. • Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.

🎯 Requirements

• Bachelor's degree (or equivalent) • Minimum of 5 years of monitoring experience • Experience with Phase I Oncology studies • Ability to travel to other regions for SWAT and/or oversight visits • Strong analytical problem-solving skills and critical thinking abilities. • Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).

🏖️ Benefits

• Health insurance • Flexible work arrangements