Job description:
1. Fully responsible for quality monitoring and management of clinical research projects, and if necessary, responsible for monitoring key centers to ensure that trial projects are strictly conducted in accordance with protocols, SOPs, and relevant regulations;
2. Communicate in a timely manner with the sponsor or superiors, conduct center screening, determine the main researchers and participating researchers, complete the overall cost budget of the project in a timely manner, and submit it for approval by superiors;
3. Develop an overall project schedule, assist each center CRA in completing the schedule of each center, complete the comprehensive launch, execution, and completion of the experimental project according to the plan, and effectively communicate and coordinate with other personnel related to the project as needed, such as medical writing, data and statistics, etc;
4. According to the established experimental plan, complete the corresponding case report form, original medical record book, project management form and other documents, and submit them to the superior for review; Submit ethical materials to the team leader's unit center and obtain ethical approval from the center;
5. Responsible for the budget and procurement of experimental materials, including the printing, distribution, and transportation of case report forms, informed consent forms, and other related materials;
6. Review the clinical research contracts of each center, guide CRA to negotiate and sign research contracts with each center;
7. Prior to the full launch of the project, provide pre launch training to project team members and promote the launch of each center according to the plan; Review all reports from project team members, maintain effective communication with all relevant personnel, and conduct routine quality control and progress reports during the project process;
8. Responsible for communicating and coordinating with the Data Management Department, Biostatistics Department, and Medical Affairs Department to complete the data management plan/report, statistical analysis plan/report, Q&A, data review meeting, summary meeting, and summary report as planned;
9. Assist in other work tasks arranged by superiors.
Job requirements:
1. Bachelor's degree or above in clinical medicine or pharmacy;
2. Fully possess at least 3 years of CRA experience, knowledge, abilities, and quality requirements; At least 2 years of work experience in the same position as a PM;
3. Proficient in using computers and office software;
4. Possess independent work ability and strong teamwork spirit; Being able to integrate into the team and contribute to the team;
5. Possess excellent written and oral communication skills, adept at active and proactive communication, able to interact with various types of clients/researchers, and establish good relationships; Possess service awareness and the potential to be customer-centric;
6. Possess excellent team organization and project management skills, such as organizing project team meetings, being able to quickly respond to problems and come up with solutions;
7. Possess excellent training and presentation skills.