1. Responsible for the research and follow-up of clinical drug research projects, including the progress of domestic and overseas similar studies, market status, and disease treatment guidelines.
2. Responsible for the drafting, review and revision of clinical-related documents, including clinical trial protocols, informed consent forms (ICFs), clinical research overviews, investigator brochures (IBs), clinical study reports, and safety reports.
3. Conduct internal and external medical training; provide medical affair support to the operation team and CRO partners, such as reviewing and revising project initiation and ethical review documents, and drafting relevant explanatory documents.
4. Provide professional medical support throughout the launch and implementation of clinical trials. Participate in trial kick-off meetings, be proficient in medical monitoring, medical review and medical quality assurance procedures, and collaborate with cross-functional teams including clinical operations, biostatistics and pharmacovigilance. Timely respond to and resolve medical-related issues, and effectively collect and evaluate feedback from all parties.
5. Communicate and maintain sound cooperative relationships with principal investigators, clinical researchers and academic experts, deliver professional medical support, and drive steady progress of clinical projects.
6. Assist in the analysis of clinical research data, conduct retrieval and review of Chinese and English academic literatures, and support the preparation of Chinese and English research reports and academic paper publications.
7. Assist all internal departments with other medical and technical work as required.
