Clinical Research Associate I/II/Senior

🔥 0 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟠 Senior

🧪 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 (SDV) and ensure clinical trials data are submitted to data management in a timely fashion • Identify issues that may impact the conduct of the study and ensure appropriate closure • Manage investigator site workload and ensure studies run efficiently and meet key objectives • Ensure studies comply with ICH/GCP, local laws, and Client SOPs and procedures • Maintain patient safety and report safety issues according to regulatory requirements • Inform Principal Investigators and site staff of issues • Develop corrective and preventative actions with investigators and site personnel • Manage all aspects of site management from site selection through study closeout • Train site staff on protocols, amendments, and Client processes • Maintain knowledge of the product, protocol, and therapy area • Interact with healthcare professionals • Ensure monitored data meets quality standards and is entered into Client systems promptly • Report study progress after each investigational site visit • Identify, catalogue, and manage issues through closure • Maintain accurate site-level information on the clinical trials registry • Obtain information for Investigator Initiation Package documentation and assist CTA with site setup • Maintain Site Master File and logs • Ensure ELARA and/or Client TMF is complete and accurate • Quality-control documents in ELARA and/or TMF • Generate site monitoring reports and 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, good at communication • A flexible attitude with respect to work assignments and new learning, quickly-learning • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail • Willingness to work in a matrix environment and to value the importance of teamwork • At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience • Good knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research • Degree in Life Science, Nursing, Pharmacy, or other relevant education background • Bachelor’s degree or above, or equivalent