Clinical Research Associate – CRA II/Senior, Bilingual French/English

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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 and generate visit/contact reports • Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff • Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol • Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s) • Evaluate the quality and integrity of the reported data, site efficacy and drug accountability • Monitor completeness and quality of Regulatory Documentation and perform site document verification

🎯 Requirements

• 18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA) • Bachelors or equivalent degree in biological science, pharmacy or other health related discipline • Strong interpersonal, written, and verbal communication skills within a matrixed team • Ability to work in a self-driven capacity with a sense of urgency and limited need for oversight • A client focused approach to work with a flexible attitude with respect to assignments and new learning • The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s) • An honest and ethical work approach • Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word • Fluency (written & spoken) in both English and French.

🏖️ Benefits

• World class technology and training • Bonus incentive program • Opportunity to work within multiple therapeutic areas • Career advancement opportunities