Clinical Research Associate (CRA)

We are seeking an experienced and motivated Clinical Research Associate (CRA) to manage and monitor clinical trial sites across China. The successful candidate will ensure that assigned sites conduct studies in compliance with the approved protocol, ICH-GCP guidelines, company Standard Operating Procedures (SOPs), and all applicable Chinese regulatory requirements (including NMPA regulations). This role is critical to ensuring data quality, subject safety, and the overall integrity of our clinical trials in China.

• Perform full scope of site management activities through onsite and remote monitoring visits (pre-study, initiation, routine monitoring, and close-out).
• Conduct source data verification (SDV) and source data review (SDR) to ensure accuracy, completeness, and reliability of clinical trial data.
• Verify that the rights and well-being of human subjects are protected and that informed consent is obtained and documented properly in accordance with GCP and local regulations.
• Review the management of investigational product (IP) at sites, including storage, dispensing, accountability, and reconciliation.
• Identify, document, track, and ensure timely resolution of site issues, protocol deviations, and data discrepancies.
• Complete monitoring visit reports and follow-up letters accurately and within required timelines.
• Ensure the completeness and quality of the site-specific Trial Master File (TMF) and ensure essential documents are collected and filed appropriately.
• Build and maintain effective, collaborative relationships with Principal Investigators, sub-investigators, and site study coordinators.
• Provide ongoing training and support to site staff on the study protocol, procedures, GCP, and data entry requirements.
• Proactively manage site performance, including patient recruitment and retention strategies.
• Collaborate with local vendors (e.g., Central Labs, IVRS) as needed at the site level.
• Prepare for and may participate in regulatory inspections and internal audits at clinical sites.

• Bachelor’s degree or higher in Life Sciences, Medicine, Pharmacy, Nursing, or a related field is required.
• Minimum of 2-3 years of independent, on-site monitoring experience as a CRA in China, within a global pharmaceutical company or CRO.
• In-depth knowledge and proven experience applying ICH-GCP and Chinese GCP (GCP) and NMPA regulatory requirements.
• Strong understanding of the clinical trial landscape and site dynamics in China.
• Excellent attention to detail, problem-solving, and analytical skills.
• Outstanding organizational and time management skills, with the ability to manage multiple sites and priorities effectively.
• Strong written and verbal communication skills in English are essential for international reporting and documentation.
• Ability to work independently with minimal supervision and as part of a regional/global team.