Clinical Research Associate I

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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

• Drive study performance at the sites. • Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents. • Provide the required monitoring visit reports within required timelines. • Proactively identify study-related issues and escalates to Local Study Teams as appropriate. • Contribute to the selection of potential sites and investigators. • Train, support and advise Investigators and site staff in study related matters. • Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations. • Manage study supplies, drug supplies and drug accountability at study sites. • Perform source data verification according to SDV plan. • Ensure data query resolution. • Work with data management to ensure quality of the study data. • Ensure accurate and timely reporting of Serious Adverse Events. • Share relevant information on patient recruitment and study site progress within local Study Team. • Update VCV and other systems with data from centers as per required timelines. • Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.

🎯 Requirements

• Minimum 2-year experience as CRA, performed all tasks for a CRA position • Good knowledge of the clinical study and drug development processes, GCP/ICH guidelines and relevant local regulations. • Good computer skills in Microsoft and other software. • Fluent in both oral and written English; fluent in host country language required.

🏖️ Benefits

• Health insurance • Professional development opportunities