Clinical Research Associate II

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.

• Detect issues that could affect the study's execution and ensure they are resolved appropriately.

• Proactively handle an increased workload at investigator sites in line with experience.

• Ensure compliance of studies with ICH/GCP, local regulations, and Client SOPs and procedures.

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

• Notify the Principal Investigator and site personnel of any issues encountered.

• Collaborate with the Principal Investigator and site staff to formulate corrective and preventive actions.

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

• Educate site personnel on protocols, amendments, and Client processes.

• Maintain comprehensive knowledge of products, protocols, and therapy areas for discussions with investigators.

• Engage with healthcare professionals effectively.

• Ensure that monitored data meets quality standards and is entered into Client systems in a timely manner.

• Provide updates on study progress following each investigational site visit.

• Identify, document, and manage issues to resolution.

• Keep accurate site-level information in the corporate clinical trials registry.

• Gather information for Investigator Initiation Package documentation and assist the Clinical Trial Associate with site setup.

• Maintain the Site Master File and log properly.

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

• Conduct quality control on relevant documents in ELARA and/or TMF.

• Generate site monitoring reports and maintain monitoring logs diligently.

• Complete mandatory training, timesheets, expense reports, and CV updates as required.

• Stay informed of and comply with Parexel processes, ICH-GCP, and applicable regulations.

⛳️ Requirements

• Proficient in computer literacy, 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.

• Flexible attitude towards work assignments and eagerness to learn quickly.

• Capability to manage multiple and diverse tasks with enthusiasm while prioritizing workload attentively.

• Willingness to work in a matrix environment and appreciate the significance of teamwork.

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

• Solid understanding of ICH/GCP, and relevant international and local regulations governing Clinical Research.

• Degree in Life Sciences, Nursing, Pharmacy, or a related field.

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

🏝️ Benefits

• Comprehensive health insurance coverage.

• Opportunities for professional development and career advancement.

• Flexible working hours and a supportive work environment.

• Competitive salary and performance-based bonuses.