Clinical Research Associate I/II/Senior

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

📋 Description

• Perform source data verification (SDV) and ensure that clinical trial data is submitted to data management promptly.

• Identify potential issues that may affect the study's execution and ensure they are appropriately resolved.

• Oversee the workload at investigator sites to ensure studies operate efficiently and achieve key objectives.

• Ensure compliance of studies with ICH/GCP, local laws, and Client Standard Operating Procedures (SOPs).

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

• Communicate issues to Principal Investigators and site staff.

• Collaborate with investigators and site personnel to develop corrective and preventative actions.

• Manage all facets of site management from site selection through to study closeout.

• Provide training to site staff regarding protocols, amendments, and Client processes.

• Keep abreast of the product, protocol, and therapeutic area knowledge.

• Engage with healthcare professionals.

• Ensure that monitored data meets quality standards and is entered into Client systems without delay.

• Report on study progress following each investigational site visit.

• Identify, document, and manage issues until resolution.

• Maintain accurate site-level information within the clinical trials registry.

• Collect information for Investigator Initiation Package documentation and assist the Clinical Trial Assistant (CTA) with site setup.

• Maintain the Site Master File and related logs.

• Ensure that ELARA and/or Client Trial Master File (TMF) is complete and accurate.

• Quality control documents within ELARA and/or TMF.

• Generate site monitoring reports and keep monitoring logs updated.

• Complete necessary training, timesheets, expense reports, and updates to the CV.

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

⛳️ Requirements

• Proficient in computer applications including word processing, spreadsheets, and PowerPoint.

• Fluent in Chinese.

• Strong command of written and spoken English is essential.

• Excellent interpersonal skills and effective communication abilities.

• Adaptable to work assignments and new learning opportunities, with a capacity for quick learning.

• Capability to manage a variety of tasks with enthusiasm while prioritizing workload and maintaining attention to detail.

• Willingness to operate in a matrix environment and recognize the significance of teamwork.

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

• Solid understanding of ICH/GCP and relevant international and local regulations pertaining to Clinical Research.

• Degree in Life Science, Nursing, Pharmacy, or a related educational background.

• Bachelor’s degree or higher, or equivalent qualifications.

🏝️ Benefits

• Comprehensive training and development opportunities.

• Competitive salary and performance-based incentives.

• Flexible working environment.

• Opportunities for career advancement.