招聘要求： 1、Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements 2、Site monitoring experience, and Basic understanding of the clinical trial process 3、Ability to review and evaluate clinical data 4、Computer literacy desirable, including the using on general office software 5、Good oral and written communication skills 6、English knowledge can support daily work, including written and oral 7、Bachelor degree, or above, in medicine, science or related discipline 职位描述： Be responsible for performing study site management activities, including, pre-study visit, site start up, site initiation, routine site monitoring visit and site close out, and ensuring site is managed according to Hutch-med SOPs, GCP and other relevant regulations. • The responsibilities of the CRA I include, but are not limited to: • Act as the main line of communication between the sponsor and clinical site • Responsible for all aspects of study site management including conduct of pre-study visit, and site start up activities including site initiation visit, routinemonitoringandclose-outofclinicalsites,maintenanceofstudyfiles;liaise with vendors; and other duties, as assigned • General On-Site Monitoring Responsibilities: 1) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to enroll qualified patient(s) into study 2) Ensure study training is released to relevant site staff(s) before study specific activities 3) Ensure the protection of study patient by verifying that informed consent procedures and protocol requirements are adhered to according to relevant requirements 4) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review 5) Monitor data for missing or implausible data 6) Ensure the resources of the sponsor are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines 7) Verify that all delegated site staffs, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout 8) Track and follow-up on serious adverse event (SAE) and SAE reporting 9) Track and follow-up on study site payment(s) 10) Verify that the investigator follows the approved protocol and all GCP procedures 11) Verify that source data/documents and other trial records are accurate, complete, and well maintained 12) Verify adverse events, concomitant medications, and intercurrent diseases are reported in accordance with the protocol on the CRFs • Update, track and maintain study-specific trial management tools/ systems • Generate and track investigational product shipments and study supplies, as needed • Attend investigators' meetings, project team meetings and teleconferences accordingly • Report the site management activities via Monitoring Visit Report, contact report or other types of reports • Collect and upload essential documents into eTMF system according relevant requirements • Ensure site issue is followed-up and closed in appropriate way within timeline • Due to the nature of this position it may be required for the employee to travelin the efficient way and according to study specific frequency and Hutch-med travel policy • Perform other duties as assigned by management 简历投递邮箱：winniew@hutch-med.com