Senior Clinical Research Associate – FSP

🕒 2 days ago

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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

• Oversight of Monitoring Responsibilities and Study Conduct • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock • Serve as the primary point of contact for assigned investigator sites during study conduct • Partner with SCP to perform investigator site development, coaching and training of site personnel • Conduct onsite, remote/electronic monitoring as needed • Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit • Submit all required reports, documentation, updates and tracking within required timeframes

🎯 Requirements

• At least 3+ years of CRA experience from Australia/New Zealand • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

🏖️ Benefits

• Health insurance • 401(k) retirement plans • Paid time off • Flexible working arrangements • Professional development opportunities