职位描述
新药药品临床监查Ⅰ期Ⅱ期
• 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.
• 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.
Qualifications
• 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.
• 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.
登录查看完整内容
