Clinical Research Associate II – Senior Clinical Research Associate

🔥 15 hours ago

🗽 New York – Remote

🗽 New York – 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

• 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 support enrollment, database release, site quality, compliance, and stakeholder engagement • Resolve protocol-related issues and collaborate with the Site Care Partner and study team • Manage clinical trial activities from site activation through database lock • Serve as primary contact for assigned investigator sites and facilitate information flow among study teams, vendors, and sites • Coach and train site personnel and provide protocol training • Support recruitment initiatives and address site activation and recruitment issues • 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 Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply information, study progress, and metrics • 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 undertake unblinded monitor responsibilities when appropriate • Maintain product, protocol, and therapy-area knowledge and support patient safety and eligibility • Support Quality Event remediation and audit corrective action/preventive action activities

🎯 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, or medical background, or equivalent

🏖️ Benefits

• Equal opportunity employer • Travel reimbursement/support may be associated with required business travel (not explicitly stated as a benefit)