1.Responsible for the quality monitoring and management of clinical research projects, responsible for the inspection of centers to ensure that the trial projects are in accordance with the trial plan, the company's SOP, GCP regulations;
2. Communicate with the sponsor, center screening, determine the main investigators and participants, complete project budget in time, submit to superiors for approval and promote implementation;
3. Develop the project schedule, assist CRA of each center to complete the schedule of each center, complete the full start, implementation and termination of the pilot project as planned,communicate and coordinate with other personnel related to the project;
4. Assist CRA of the project team to sort out, submit the ethical data of each research center, obtain the center's ethical approval;
5. Responsible for the budget and purchase of test materials, including the printing, distribution and transportation of case report forms, informed consent forms and other materials;
6. Review the clinical research contracts of each center and guide CRA to complete the negotiation and signing of research contracts with each center;
7. Conduct pre-launch training for project team members, promote the launch of each center as planned; review report of project team members, communicate with project members, perform quality control and progress reports;
8. Responsible for CRA training and management of clinical monitors of the project team member, assist CRA in formulating a monitoring plan,selectively conduct collaborative monitoring to ensure the progress and quality of the trial ;
9. Maintain a good cooperative relationship with researchers;
10. Other work assigned by superiors.