Clinical Research Associate, CRA II – Hematology

🔥 2 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 clinical sites from identification through closeout • Serve as the primary point of contact for assigned clinical sites • Conduct qualification, site initiation, monitoring, and termination visits at assigned clinical sites • Prepare timely visit and contact reports • Address site questions and resolve issues to support successful study execution • Oversee study integrity and relationships with investigators and site staff • Review trial performance and safeguard participant rights, safety, and well-being • Develop patient recruitment strategies with clinical sites • Ensure compliance with SOPs, study protocols and amendments, Good Clinical Practice, and regulatory requirements • Evaluate reported data quality and integrity, site performance, and investigational product accountability • Monitor regulatory documentation completeness and quality and perform site document verification

🎯 Requirements

• At least 18 months of direct onsite monitoring experience as a Clinical Research Associate • Hematology/Hematologic Oncology and CAR-T clinical trial monitoring experience • Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline • Knowledge of Good Clinical Practice, applicable regulatory requirements, and clinical trial processes • Experience using a Clinical Trial Management System, an Electronic Document Management System, and Microsoft Office applications, including Excel and Word • Strong site relationship management, problem-solving, communication, interpersonal, written, verbal, organizational, and attention-to-detail skills • Ability to work independently with urgency and limited oversight • Ability to manage multiple priorities, evaluate changing scenarios, apply study protocols, and meet project timelines • Ability to collaborate within a matrixed team and communicate clearly with internal and external stakeholders

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Some roles may be eligible for additional incentives, bonuses, or other compensation programs