Clinical Research Associate II/Senior Clinical Research Associate

🕒 August 27

🐊 Florida – Remote

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⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 24%

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Logo of Parexel

Parexel

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 investigator site relationships and assigned clinical trial sites from activation through database lock and close-out • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, GCP and Sponsor standards • Serve as primary contact for assigned investigator sites and coordinate information flow with study teams and vendors • Coach and train site personnel on protocols, compliance and patient safety • Support site activation, patient recruitment and enrollment initiatives • Conduct onsite and remote/electronic site initiation, routine monitoring and closure 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 and study progress tracking • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release and, where appropriate, perform unblinded monitor responsibilities • Maintain product, protocol and therapy-area knowledge and support patient safety and clinical guidance • Drive Quality Event remediation and support audit CAPA 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, medical background or equivalent

🏖️ Benefits

• Equal opportunity employment • Onsite, remote/electronic monitoring as needed • Investigator meetings may be virtual or face-to-face

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