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 promptly.

• Detect issues related to study conduct and facilitate their resolution.

• Oversee the workload of investigator sites to ensure studies fulfill their primary objectives.

• Guarantee compliance of studies with ICH/GCP, local regulations, and client standard operating procedures (SOPs).

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

• Notify Principal Investigators and site personnel about any arising issues.

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

• Handle all facets of site management from site selection to study closure.

• Educate site personnel on protocols, amendments, and client procedures.

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

• Monitor data quality and ensure timely entry into systems.

• Provide updates on study progress following each site visit and resolve issues effectively.

• Keep site-level clinical trial registry information up to date.

• Acquire and retain documentation related to the Investigator Initiation Package, Site Master File, monitoring logs, ELARA, and/or Trial Master File records.

• Conduct quality control for relevant documents and produce site monitoring reports.

• Complete necessary training, timesheets, expense reports, CV updates, and compliance tasks.

⛳️ Requirements

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

• Fluent in Chinese.

• Strong command of both written and spoken English is essential.

• Excellent interpersonal and communication skills.

• Adaptable attitude towards work assignments and eagerness to learn.

• Capable of managing multiple tasks, prioritizing workload, and maintaining a keen 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 applicable international and local clinical research regulations.

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

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

🏝️ Benefits

• Competitive salary and benefits package.

• Opportunities for professional development and career advancement.

• Flexible working arrangements.