Clinical Research Associate, FSP

🔥 4 hours ago

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 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

• Implement and monitor clinical trials to ensure sponsor and investigator obligations are met • Assess qualification of potential investigative sites • Initiate clinical trials at investigative sites and instruct site personnel on proper trial conduct • Close clinical trials at investigative sites • Review and verify accuracy of clinical trial data on site or remotely • Provide regular site status information to team members and trial management • Update trial management tools and applicable tracking systems • Complete monitoring activity documents required by SOPs or contractual obligations • Collaborate with clinical team members to resolve trial and clinical issues • Escalate site and trial-related issues until resolved or closed • Perform essential document site file reconciliation • Perform source document verification and query resolution • Assess investigational product accountability, dispensation, and compliance • Verify SAE reporting according to trial specifications and ICH GCP guidelines • Communicate with investigative sites • Ensure required training is completed and documented • Serve as the main observer/assessor of site activities • Facilitate audits and audit resolution • Undertake related duties such as protocol amendment submissions and Investigator site budget negotiation • Mentor junior-level CRAs and serve as a resource for new employees • Perform additional clinical operations tasks and advanced-negotiation clinical tasks as assigned • Interact with other functional areas to resolve site issues and facilitate trial timelines

🎯 Requirements

• Compliance with applicable local regulatory requirements and ICH GCP guidelines • Experience appropriate for mentoring junior-level CRAs and serving as a resource for new employees • Ability to perform clinical trial monitoring, site qualification, initiation, instruction, close-out, and remote/on-site data review • Ability to perform source document verification, query resolution, essential document reconciliation, and investigational product accountability • Ability to verify SAE reporting according to trial specifications and ICH GCP guidelines • Ability to facilitate audits and audit resolution • Ability to negotiate Investigator site budgets when assigned • Ability to complete required training and documentation • Ability to communicate with investigative sites and collaborate with clinical team members • Ability to use applicable clinical trial tracking and management systems