1. Coordinate the relationship between the company and each clinical research center, and deal with various problems arising in clinical research work;
2. According to the requirements of the test plan, SOP and GCP, conduct research center screening, start-up, monitoring and closing visits;
3. Ensure that clinical trials are conducted in accordance with the national GCP requirements and trial protocols through a standardized monitoring process;
4. Be responsible for CRA work arrangement, management and related training;
5. Check the legality, accuracy and completeness of the data in the case report form (CRF);
6. Be responsible for the proper storage, distribution and use of test supplies.
1. A Bachelor’s degree or above in medicine, pharmacy, biochemistry, pharmaceutical management and other related majors;
2. Good understanding of relevant laws and regulations of drug registration and relevant drug research guidelines, the drug registration application process and various steps, and the preparation and review of application materials;
3. Innovative spirit and excellent ability in organization and coordination, project operation, analysis and judgment, and emergency response;
4. Strong writing, information retrieval and analysis and research capabilities;
5. Good English reading and writing skills and the ability to proficiently read and accurately understand related foreign websites and documents such as FDA and EMA;
6. Active and rigorous attitudes towards work, a strong sense of responsibility and confidentiality, and good team spirits.
Lindmik Pharmaceutical(Suzhou)Co.,Ltd is a high-tech pharmaceutical enterprise focusing on the research and development, production and sales of innovative pharmaceutical preparations.Equipped with a number of its own innovative R&D platform of dosage forms, including the transdermal drug delivery system, and at the same time, actively introducing the world’s leading nano-based drug delivery, microspheres drug delivery and other cutting-edge pharmaceutical technologies by means of “license in”, the company is a new rapidly developing company pharmaceutical companies that catches people’s eyes.
12th Floor, Building 5, Tianyun Plaza, 111 Wusongjiang Avenue, Guoxiang Street, Wuzhong District, Suzhou City
0512-66020899
0512-66022699
215124