Clinical Research Associate II/Sr. Clinical Research Associate

🔥 0 minutes ago

⛰️ Colorado – Remote

⛰️ Colorado – 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

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP), applicable prevailing laws, GCP, and the Sponsor's standards • Manage operational aspects of clinical trial activities at assigned investigator sites from site activation through database lock • Serve as primary point of contact for assigned investigator sites • Facilitate information flow between study team members, vendors, and investigator sites • Perform investigator site development, coaching, and training of site personnel • Provide protocol training and address protocol-related questions • Support investigator meetings, enrollment, site activation, recruitment initiatives, and recruitment issue resolution • 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 reports, documentation, updates, and tracking, including TMF documentation, site reports, protocol deviations, recruitment, clinical supply management, study progress, and metrics • Identify and resolve investigator 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 as needed • Maintain understanding of the product, protocol, and therapy area • Support patient safety, eligibility, and clinical guidance to investigators • Drive Quality Event remediation and audit CAPA activities when applicable

🎯 Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations • Minimum 2 years relevant experience in clinical research site monitoring • Fluent in English and in 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 without regard to legally protected status • Consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status