Clinical Research Associate II/Sr. Clinical Research Associate

🔥 17 hours ago

🌵 Arizona – Remote

🌵 Arizona – Remote

⏰ Full Time

🟠 Senior

🧪 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 site management, monitoring, and close-out of assigned clinical trial investigator sites • Ensure patient safety and quality study execution according to applicable laws, GCP, and sponsor standards • Manage investigator site relationships and operational aspects from site activation through database lock • Serve as primary contact for assigned investigator sites and collaborate with Site Care Partners and study teams • Facilitate information flow among study team members, vendors, and investigator sites • Train and coach site personnel on protocols and compliance • Support site activation, patient recruitment, enrollment, and investigator meetings • Conduct onsite and remote/electronic site initiation, routine monitoring, and close-out activities • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management, study progress, and metrics • Identify and resolve site issues and develop corrective and preventive actions • Resolve data queries and prepare and conduct site close-out activities • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release and perform unblinded monitoring when appropriate • Maintain product, protocol, and therapy-area knowledge and support patient safety and clinical guidance • Drive Quality Event remediation and audit observation CAPA activities when applicable

🎯 Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations • Minimum 2 years of relevant experience in clinical research site monitoring • Fluent in English and the native language(s) of the country of work • 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 • Ability to conduct onsite and remote/electronic monitoring • Knowledge of protocol, therapy area, patient safety, eligibility, and clinical guidance • Location specified as United States/Arizona/Remote United States

🏖️ Benefits

• Equal opportunity employment consideration regardless of legally protected status • Opportunity to contribute to therapies that benefit patients and improve global health