中国·银河集团www.9873.cσm|官方网站-Made in China

1. Receive the clinical trial project, prepare the first draft of the clinical trial project medical plan;

2. Modify the medical plan based on the opinions of PI, the project inspection department, the statistics department;

3. Prepare the first draft of the project plan, researcher's manual, informed consent, research medical record, CRF, PPT;

4. Participate in the coordination meeting, present the PPT according to the plan and materials recognized by the medical director, listen to and record the expert opinions of the coordination meeting, modify the plan accordingly;

5. Adjust the plan according to the opinions of the ethics committee;

6. During the project test, answer technical questions raised by researchers and project manager;

7. Receive the first draft of the statistical report of the statistics department, write draft of the summary report, communicate with the statistics department and the project manager, make corresponding adjustments to the summary report.

1. 3 years of work experience, clinical work experience, major in medicine or clinical medicine;

2. Strong medical editing skills, proficient in medical professional literature retrieval,  strong text organization and abstract ability;

3. Clinical knowledge, good logical thinking and analytical judgment.

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.

1. Bachelor degree or above in clinical medicine or pharmacy, 5 years of clinical trial work experience, 2 years of project management experience;

2. Work independently, team spirit, adapt to business trips;

3. written and oral expression skills, active communication, communicate with various types of clients/researchers, good relationships; sense of service and the potential to be customer-centric;

4. Team organization, project management skills, such as organizing project team meetings, respond to problems and come up with solutions;

5. Team training and public speaking skills;

6. Experience in phase I clinical trials is preferred.