Senior Clinical Research Associate

🔥 6 minutes ago

🏄 California, Florida, +1 more states – Remote

🏄 California – Remote 🐊 Florida – Remote 🤠 Texas – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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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

• Monitor and manage clinical sites in compliance with CFR and ICH/GCP guidelines • Evaluate, initiate, monitor, and close clinical sites • Identify and qualify potential investigators • Perform pre-study, site initiation, interim monitoring, and close-out visits • Assist with site start-up, essential document review, and collection • Train investigators and site staff on protocols, procedures, documentation, and regulatory requirements • Monitor protocol and GCP compliance • Perform source data review and verify clinical data against source documents • Ensure timely data entry and query resolution • Perform drug accountability and ensure adequate drug supply • Review research specimen documentation, storage, processing, and shipment • Collaborate with drug safety on serious adverse event reporting • Maintain complete and accurate site regulatory files and monitor IRB compliance • Track and report study progress, protocol variations, issue resolution, and follow-up compliance • Prepare visit reports, confirmation letters, and follow-up letters • Maintain the Clinical Trial Management System (CTMS) • Resolve site issues and action items or escalate them per the Clinical Monitoring Plan • Assist Data Management and provide co-monitoring support • Contribute to quality audits, department initiatives, study documents, and vendor management or data review activities • Attend required staff meetings and training • Complete required training, timesheets, expense reports, and CV updates

🎯 Requirements

• Phase I clinical trial monitoring experience required • 4+ years of prior CRA monitoring experience in a CRO or Pharma organization required • Bachelor of Arts/Science (BA/BS), or equivalent, or relevant experience and training with at least six (6) years of pharmaceutical/biotech experience • Proficiency in written and spoken English required • Proficiency in local languages, as applicable • Willingness and ability to travel 55–75% • Previous experience with Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and CTMS systems • Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint • Excellent communication and organizational skills • Ability to discuss scientific, medical, and therapeutic area information with medical professionals • Ability to manage multiple tasks, prioritize workload, and solve problems simultaneously • Flexibility toward work assignments, learning, and travel • RN or health care professional preferred • Oncology/immunology experience preferred • Experience on global clinical trials preferred • FDA/EMEA inspection readiness preferred

🏖️ Benefits

• Full-time employment • Equal opportunity employment