1. Responsible for the screening of research centers, pre-launch visits, and timely submission of relevant questionnaires and reports; 2. Assist the convening of the researcher's meeting, as the main contact person of the research center personnel, responsible for the schedule of the relevant personnel; 3. Assist researchers in submitting ethical review materials, responding to ethical review comments, and reviewing the integrity and compliance of ethical approval documents and member lists. norm; 4. Responsible for the communication and revision of the research center contract; 5. In accordance with the company's project plan, SOP and relevant laws and regulations, organize the start-up, supervision, and management of research centers. management, closing and other work, and timely complete the relevant visit report or project progress report; 6. Responsible for organizing and coordinating the research center's audit from the applicant (or any third party) and official on-site inspection; 7. Formulate the enrolment plan and process plan of the research center in charge, and customize relevant auxiliary tools according to the specific requirements of the research center; 8. Manage the research center related materials (such as ICF, laboratory test kits) to ensure that the materials are sufficient and available; 9. Manage research products, ensure that research products are used correctly, and ensure that research products are received, stored, handled, used, and recycled in compliance with requirements and record it truthfully, completely and accurately; 10. Manage the recovery and destruction of research products and keep accurate records; 11. Assist researchers to complete data entry in a timely manner and perform data cleaning in a timely manner; 12. Ensure that the data collected by the research center is true, complete and accurate through data traceability and original document review; 13. Ensure that investigators are able to process, record and report all AE/SAE/PSUR as required by regulations, and report relevant regulatory management department; 14. Manage relevant documents and data, and enter relevant documents and data management systems (such as CTMS, PV, eTMF) in a timely manner as required by the company 15. Make sure to participate in regular or irregular project management meetings, and be able to follow up on relevant resolutions in a timely manner; 16. Ensure that you participate in regular or irregular training organized by the company, and ensure that any online training can be completed in a timely manner; 17. Responsible for the calculation and submission of budgets for research center payments, and track related bills; Qualifications: 1. Result-oriented, strong sense of responsibility, good communication skills, able to travel; 2. 1 year or more experience in clinical trial monitoring 3. Bachelor degree or above in clinical, pharmacy and other medicine-related majors; 4. Proficient in operating Microsoft Office office software; This position requires frequent travel. |