Clinical Research Associate II

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

📋 Description

• Perform verification of source data and ensure that clinical trial data is submitted to data management in a timely manner.

• Recognize issues related to study conduct and ensure that they are resolved appropriately.

• Oversee the workload of investigator sites to guarantee that studies operate smoothly and meet their goals.

• Ensure adherence to ICH/GCP guidelines, local regulations, and client standard operating procedures (SOPs) and protocols.

• Safeguard patient safety and report any 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 measures.

• Manage sites from the selection phase through to the study's conclusion.

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

• Maintain a thorough understanding of the product, protocol, and therapeutic area for discussions with investigators.

• Engage with healthcare professionals to strengthen client credibility.

• Ensure that monitored data adheres to quality standards and is entered into client systems without delay.

• Report on study progress following site visits and track and resolve issues until closure.

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

• Obtain and maintain documentation for the Investigator Initiation Package, Site Master File, ELARA, and/or Trial Master File.

• Conduct quality control of relevant documents and produce monitoring reports.

• Maintain monitoring logs.

• Complete all necessary training, timesheets, expense reports, and update CVs.

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

⛳️ Requirements

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

• Fluent in Chinese.

• Strong written and spoken English skills are essential.

• Excellent interpersonal skills and effective communication abilities.

• Adaptable attitude towards work assignments and a willingness to learn; quick to grasp new concepts.

• Capability to manage multiple tasks, prioritize workloads, and maintain meticulous attention to detail.

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

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

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

• A degree in Life Sciences, Nursing, Pharmacy, or another relevant educational background.

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

🏝️ Benefits

• Comprehensive training and development opportunities.

• Competitive salary and performance-based incentives.

• Collaborative and supportive work environment.

• Opportunities for career advancement.

• Access to health and wellness programs.