Clinical Research Associate II

Parexel

. Conduct source data verification and ensure clinical trial data is submitted to data management promptly .

Posted 9/21/2026full-timeRemote • ChinaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Monitoring and Site Management, ensuring compliance with ICH/GCP and local regulations while effectively managing investigator sites and maintaining patient safety. Proficient in data verification, quality control, and training site staff on protocols and processes.

Highest-signal resume keywords

Clinical Monitoring ExperienceICH/GCP ComplianceSite ManagementData VerificationBilingual Proficiency in Chinese and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Data ManagementQuality ControlData EntryRegulatory ReportingSite Selection and CloseoutCorrective and Preventive ActionsMonitoring Logs MaintenanceSite Monitoring Reports GenerationTraining and DevelopmentPatient Safety Management

Soft Skills

Interpersonal SkillsCommunication SkillsAttention to DetailFlexibilityTeamwork

Tools & Technologies

ELARATrial Master FileSite Master FileMicrosoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Clinical ResearchLife ScienceNursingPharmacyRegulatory Requirements

About the role

Key responsibilities & impact

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

What you’ll need

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