1.Draft clinical trial protocol. 

2. Modify the clinical trial protocol according to the opinions from line manager, clinical operation relevant departments and statistics department. 

3. Prepare investigator brochure, informed consent form, source document templates, CRF and PPT draft. 

4. Participate in the protocol discussion meeting, demonstrate the PPT according to the clinical trial protocol and relevant materials by the medical director, receive and record investigators opinions, and modify the protocol accordingly. 

5. Modify clinical trial protocol according to the opinions of ethics committee. 

6. Answer the technical questions raised by the investigator and project manager (monitor) during whole trial. 

7. Draft site summary and clinical study report(first draft) according to SAR provided by statistics department, and discuss with the statistics department and the project manager to update the final reports. 

8. Make the first draft of the reply comments and supplement documents, and reply to the query from CMDE after being approved by the medical director. 

1. Bachelor degree or above in clinical medicine, pharmacy, life science, etc.

2. Have relevant work experience or clinical experience;

3. Solid professional knowledge and strong paperwork ability; those with less experience can consider the level of specialist.

1. Responsible for investigate, select, and provide relevant information of investigation sites and investigators. Provide trial related information according to trial progress. 

2.Obtain clinical trial documents and ethics committee approvals within the project plan timeline, and conduct preliminary review of ethics committee approval documents. 

3. Prepare and participate in the investigator meetings, make related records, and be responsible for the liaison and reception of investigators from site. 

4. To manage the investigation sites in charge, strictly follow GCP, SOP, trial plan and Chinese laws and regulations, and complete the selection, initiation, routine monitoring and site close-out of investigation site on time within the project timeline. 

5. Timely finish RMVR with high quality. 

6. Assist the investigation sites to report AE / SAE and follow up. 

7. By checking the informed consent process, to ensure the safety and interests of the subjects. 

8. The authenticity, accuracy and integrity of the data can be ensured by checking the source data and managing the case report form / data query form. 

9. Manage site trial items, including the investigational products, trial documents and trial related equipment.

1. Education background: Bachelor degree or above, major in medicine or pharmacy, clinical medicine background is preferred. 

2. Skill requirements: 1 year relevant position experience, able to work independently. 

3. Quality requirements: good health, cheerful personality, good at communication. 

4. Be able to travel frequently.