Clinical Research Associate II

This is a fully remote position, open to applicants in China.

📋 Description

• Perform source data verification and ensure timely submission of clinical trial data to data management.

• Recognize and address study conduct issues to facilitate appropriate resolution.

• Oversee investigator site workload to ensure studies are conducted efficiently and objectives are met.

• Ensure compliance with ICH/GCP, local regulations, and client Standard Operating Procedures (SOPs).

• Safeguard patient safety and report safety concerns in accordance with regulatory standards.

• Communicate issues to principal investigators and site personnel.

• Collaborate with investigators and site staff to develop corrective and preventive actions.

• Manage sites from initial selection through to study closeout.

• Provide training to site staff on protocols, amendments, and client processes.

• Maintain a thorough understanding of the product, protocol, and therapeutic area.

• Engage with healthcare professionals to enhance client credibility.

• Ensure that monitored data adheres to quality standards and is promptly entered into client systems.

• Report on study progress following site visits and systematically document and resolve issues.

• Keep precise site-level clinical trial registry information.

• Acquire and manage the Investigator Initiation Package, Site Master File, ELARA, and/or Trial Master File documentation.

• Conduct quality control on relevant documents and maintain monitoring logs.

• Produce site monitoring reports.

• Complete all required training, timesheets, expense reports, and updates to CVs.

• Adhere to Parexel processes, ICH-GCP, and relevant requirements.

⛳️ Requirements

• Proficiency in computer skills including word processing, spreadsheets, and PowerPoint.

• Fluent in Chinese.

• Strong written and spoken English skills are essential.

• Excellent interpersonal and communication abilities.

• Adaptable attitude towards work assignments and a willingness to learn quickly.

• Capability to manage multiple and diverse tasks, prioritize workload effectively, and maintain attention to detail.

• Willingness to work within a matrix environment and appreciate teamwork.

• Minimum of 1.5 years of experience in Clinical Monitoring/Site Management (2 years preferred).

• Solid understanding of ICH/GCP and pertinent international and local Clinical Research regulations.

• Bachelor’s degree in Life Science, Nursing, Pharmacy, or a related field is required.

• A bachelor's degree or higher, or equivalent is necessary.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.

• Supportive and collaborative team environment.