Clinical Research Associate, CRA II – Senior

🔥 51 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites • Generate visit and contact reports • Build and maintain site relationships as the site's primary point of contact • Address and resolve site issues and questions • Oversee study integrity and promote rapport with site staff • Review trial performance and safeguard the rights and well-being of human subjects in accordance with the protocol • Develop patient recruitment strategies with clinical sites to meet enrollment timelines • Ensure compliance with SOPs, protocols and amendments, GCP, and applicable regulatory requirements • Evaluate reported data quality and integrity, site efficacy, and drug accountability • Monitor completeness and quality of regulatory documentation • Perform site document verification • Manage site quality and delivery from site identification through close-out

🎯 Requirements

• 18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA) • Bachelor's or equivalent degree in biological science, pharmacy, or another health-related discipline • Strong interpersonal, written, and verbal communication skills within a matrixed team • Ability to work independently with a sense of urgency and limited oversight • Client-focused approach with flexibility regarding assignments and new learning • Ability to manage multiple tasks, evaluate unpredictable scenarios, achieve project timelines, and apply understanding of study protocols • Honest and ethical work approach • Strong computer skills, including Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), Microsoft Excel, and Microsoft Word

🏖️ Benefits

• Bonus incentive program • World-class technology • Training catered to individual experience • Less travel and lower protocol load compared to industry peers • Opportunities to work within multiple therapeutic areas • Career advancement opportunities • Career growth support through performance discussions and evaluations • Opportunities to progress into senior CRA, line management, Quality, Project Leadership, or other positions

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