Clinical Research Associate II

🔥 0 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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

• Conduct source data verification and ensure clinical trial data are submitted to data management in a timely manner • Identify issues affecting study conduct and ensure appropriate closure • Manage investigator site workloads and support efficient study execution • 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 site selection through study closeout • Train site staff on protocols, amendments, and client processes • Maintain sufficient knowledge of the product, protocol, and therapy area for investigator discussions • Interact with healthcare professionals to enhance client credibility • Ensure monitored data meets quality standards and is entered into client systems promptly • Report site study progress after visits and catalog and manage issues to closure • Maintain accurate site-level information in the clinical trials registry • Obtain and coordinate Investigator Initiation Package documentation • Maintain Site Master Files and logs • Ensure ELARA and/or Trial Master File completeness and accuracy • Quality-control relevant documents and generate site monitoring reports • Maintain monitoring logs • 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 learner • 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) • Global study monitoring experience is preferred • Good knowledge of ICH/GCP and relevant international and local clinical research regulations • Degree in Life Science, Nursing, Pharmacy, or other relevant educational background • Bachelor’s degree or above, or equivalent