Work Schedule

Environmental Conditions

Job Description

Clinical Research Physician -FSP (Immunization)

Job Description:

 1. Responsible for writing and reviewing clinical trial-related medical documents, and responsible for the medical review of project documents (including but not limited to clinical research and development plans, clinical trial protocols, informed consent forms, investigator manuals, medical reviews, clinical trial summary reports, IND application and NDA application related documents, etc.)

2. Responsible for medical monitoring (data review, protocol violation judgment, investigator communication, etc.), safety evaluation, SAE/AE review and other medical support for phase I-III clinical trials

3. Provide professional training on diseases/products/study protocols to clinical research team members and other relevant stakeholders

4. Participate in internal and external communication and discussion related to clinical trials

5. Responsible for the evaluation and research related to the development of new drugs or the introduction of medicine

6. Responsible for the writing and publication of research papers after the clinical research data are generated

Request:

1. Master degree or above in clinical medicine

2. Experience in medical monitoring and safety evaluation of phase I-III clinical trials (at least 3 years of project experience, skin immunization project is preferred)

3. Have a good understanding of the overall process of drug development, clinical trial methods, regulatory environment in China, and ICH/GCP guidelines

4. Understand the drug registration regulations and processes in related fields

5. Have GCP certificate

6. Understand medical statistical analysis methods

7. Have good English communication skills, have basic English reading and writing skills

8. Good communication and interpersonal skills - Work well with others, motivate and encourage others

9. Ability to deliver results efficiently/granarily under pressure, accommodating business travel