Clinical Research Associate II

🔥 12 hours ago

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 • Proactively manage a greater investigator site workload commensurate with experience • 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 the Principal Investigator and site staff of issues • Develop corrective and preventative actions with PI 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 sufficient product, protocol, and therapy-area knowledge for investigator discussions • Interact with healthcare professionals • Ensure monitored data meets target quality standards and is entered into Client systems timely • Report study progress after each investigational-site visit • Identify, catalogue, and manage issues to closure • Maintain accurate site-level information on the corporate clinical trials registry • Obtain information for Investigator Initiation Package documentation and assist CTA with site setup • Maintain the Site Master File and log • Ensure ELARA and/or Client TMF is complete and accurate • Quality-control relevant documents in ELARA and/or TMF • Generate site monitoring reports and maintain monitoring logs • Complete required training, timesheets, expense reports, and CV updates • Maintain knowledge of and 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