1.Responsible for the testing and report writing of our pre-clinical biological samples.

2.Responsible for the routine testing of toxic species products.

3.Responsible for the routine testing of CMC products for small trials.

4.Responsible for the daily management of testing reagents, consumables and instruments.

5.Participate in the formal validation of bioanalytical assays.

6.Participate in the development and continuous optimization of bioanalytical assays.

7.Participate in the validation program and validation report writing, review and implementation.

8.Participate in the management and reassessment of all internal standards and key reagents in the department.

9.Participate in the writing of SOPs, reports, ROA, etc., and archiving of experimental reports and other documents in the department.

10.Complete other work as assigned by the supervisor.

1. Research center screening Start up;

2. Provide ongoing training to center personnel on GCP, research plans, and requirements;

3. During the initiation and conclusion stages of the research, collect necessary documents in a timely manner according to the requirements of the plan and regulations, and update the researcher folder and TMF in a timely manner;

4. Conduct clinical monitoring work according to the company's SOP and be responsible for managing the entire process of clinical trials;

5. Ensure that the experiment strictly follows the plan GCP and related laws and regulations implementation;

6. Assist in resolving potential issues that may arise during the experimental process;

7. Ensure timely research data Accurate Integrity;

8. Responsible for the operation and execution of clinical projects according to the project plan and schedule, ensuring that the clinical projects are completed as required;

9. Assist in organizing various meetings related to clinical trials, maintain good communication and coordination with research units and experts

1. Responsible for the preclinical pharmacodynamics of the company's new drug development Organize relevant data on toxicology and pharmacokinetics, develop pharmacological and toxicological development plans for new drug research and development, and participate in animal experiments at the animal center;

2. Responsible for CRO research to examine. Administration. Implement relevant research, track experimental progress, and analyze and summarize experimental results;

3. Responsible for researching the plan Review of technical materials such as summary reports;

4. Responsible for translating the pharmacological and toxicological sections of new drug approval documents Writing and registering CMC collaborates with clinical personnel to complete the work related to new drug application;