Clinical Research Associate – CRA II/Senior

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 site teams • Conduct qualification visits, site initiation visits, monitoring visits, and termination visits • Prepare timely visit and contact reports • Manage site quality and delivery throughout the study lifecycle • Address site questions and resolve issues to support study execution • Oversee study integrity and build relationships with investigators and site staff • Review trial performance and safeguard participant rights, safety, and well-being • Develop patient recruitment strategies with clinical sites to support enrollment timelines • 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 • Perform site document verification • Conduct onsite monitoring activities and support enrollment and study delivery

🎯 Requirements

• At least 18 months of direct onsite monitoring experience as a Clinical Research Associate • Oncology, Ophthalmology, Metabolic, Hematology or CAR-T clinical trial monitoring experience required • 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 • Ethical, patient-focused approach • Client-focused, flexible approach to assignments and continuous learning

🏖️ 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 • Additional benefit offerings in accordance with applicable plan terms • Potential eligibility for additional incentives, bonuses, or other compensation programs