Senior Clinical Research Associate – FSP

🔥 1 minute ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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 investigator site relationships and assigned clinical trial site activities from site activation through database lock and close-out • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices (GCP), and Sponsor standards • Serve as primary point of contact for assigned investigator sites and coordinate with the Site Care Partner and study team • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure • Provide site personnel coaching, training, protocol training, and recruitment support • 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 management, study progress, and metrics • Identify and resolve site issues, develop corrective and preventive actions, and resolve data queries • Ensure oversight of 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 provide clinical guidance to investigators • Drive Quality Event remediation and support audit observation CAPA development and checks

🎯 Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations • Minimum 3 years relevant experience in clinical research site monitoring • Must be 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