Job description:
1. Assist the superior leaders in selecting, managing and coordinating the research center and third-party partners (including cro, SMO, central laboratory, data management and statistical analysis, cold chain transportation, etc.) to ensure that the services are provided according to the contract requirements;
2. Follow up the clinical trials of the company's products through the standardized supervision process, and carry out them in strict accordance with the requirements of national laws and regulations and the established clinical trial scheme;
3. According to the actual needs of the trial scheme, participate in the screening, project start-up, ethical review, process supervision, center closure, etc. of the clinical research center;
4. Timely and effectively collect relevant clinical research data, ensure that all necessary documents are updated and complete in time, and ensure that all clinical trial data are true, accurate and complete;
5. Timely report and summarize the progress of clinical trial, and assist in solving the problems in the process of clinical trial;
6. Complete the contract signing, payment, drug application and inventory, coordination of sample delivery and other processes related to clinical trial activities;
7. Coordinate and maintain a good cooperative relationship with clinical trial units to ensure the smooth completion of clinical trials;
8. Complete other tasks assigned by superior leaders.
Qualification
1. Bachelor degree or above in medicine or pharmacy;
2. More than 1 year of CRA, CRC or other relevant experience in pharmaceutical enterprises and cro companies is preferred;
3. Be familiar with the whole process of clinical trial and relevant regulations and policy requirements, GCP certificate is preferred;
4. Have a certain foundation in clinical medicine and pharmacy, be familiar with the operation process of clinical trials, and understand relevant laws and regulations;
5. CET-4 or above, good reading and writing skills;
6. Strong organization, coordination and communication skills and pressure resistance;
7. Strong learning ability, quickly familiar with and master new projects and new regulations;
8. Be able to travel irregularly due to work needs.