Clinical Research Associate II

🔥 5 minutes ago

⚔️ Virginia – Remote

⚔️ Virginia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 10%

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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, monitor and close out assigned clinical trial investigator sites • Ensure patient safety and quality study execution in accordance with applicable laws, GCP and sponsor standards • Manage investigator site relationships and operational aspects from site activation through database lock • Serve as primary point of contact for assigned investigator sites • Facilitate information flow among study team members, vendors and investigator sites • Provide site personnel coaching, training and protocol support • Support site activation, recruitment initiatives and enrollment • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and site closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit required TMF documentation, site reports, follow-up letters, protocol deviations, recruitment and study progress updates • Identify and resolve site issues and develop corrective and preventive actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release and unblinded monitoring where appropriate • Maintain product, protocol and therapy-area knowledge • Support patient safety, eligibility and clinical guidance • Drive Quality Event remediation and audit CAPA activities when applicable

🎯 Requirements

• Minimum 2 years relevant experience in clinical research site monitoring • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Fluency in English and the native language(s) of the country they will work in • Ability to travel 60-80% • Valid driver’s license and passport required • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

🏖️ Benefits

• Equal opportunity employment • Travel allowance implied by required travel (no explicit benefit stated)