Clinical Research Associate II

🔥 5 hours ago

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

infoinfo

🗣️🇨🇳 Chinese Required

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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 source data verification and ensure clinical trial data is submitted to data management promptly • Identify study conduct issues and ensure appropriate closure • Manage investigator site workload to run studies efficiently and meet objectives • Ensure studies comply with ICH/GCP, local laws, and client SOPs • Maintain patient safety and report safety issues according to regulatory requirements • Inform principal investigators and site staff of issues • Develop corrective and preventive actions with investigators and site personnel • Manage sites from selection through study closeout • Train site staff on protocols, amendments, and client processes • Maintain sufficient knowledge of the product, protocol, and therapy area • Interact with healthcare professionals and support client credibility • Ensure monitored data meets quality standards and is entered into client systems promptly • Report study progress after site visits and catalog and close issues • Maintain accurate site-level clinical trial registry information • Obtain and maintain Investigator Initiation Package, Site Master File, ELARA, and/or Trial Master File documentation • Quality-control relevant documents and maintain monitoring logs • Generate site monitoring reports • Complete required training, timesheets, expense reports, and CV updates • Comply with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• Computer Literacy (word processing and spreadsheets, PowerPoint) • Proficient in Chinese • Good command of written and spoken English is required • Good interpersonal skills and communication skills • Flexible attitude toward work assignments and new learning; quick learning ability • Ability to manage multiple and varied tasks, prioritize workload, and maintain attention to detail • Willingness to work in a matrix environment and value teamwork • At least 1.5 years of Clinical Monitoring/Site Management experience (2 years preferable) • Good knowledge of ICH/GCP and relevant international and local Clinical Research regulations • Degree in Life Science, Nursing, Pharmacy, or another relevant educational background • Bachelor’s degree or above, or equivalent

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