Job Description:
1. Responsible for the monitoring of clinical trials, ensuring that all trials are carried out in strict accordance with clinical trial protocols, standard operating procedures/internal operating procedures and relevant national industry regulations; 2. Assist the project manager to manage the contract research organization, carry out comprehensive quality control and management of the research project in charge, complete the full start-up, execution and center closure of clinical trials in China on time, and communicate and coordinate with other departments related to the project in a timely and efficient manner; 3. Collaborate with other functions and suppliers to implement patient recruitment strategies and contingency plans Responsible for timely communication with superiors, selecting test centers and researchers and formulating trial budgets; 4. Responsible for assisting in filling in relevant reports and test records to ensure the accuracy, validity and completeness of data collected at the test site; Ensure that all adverse events (AEs) / serious adverse events (SAEs) / product quality complaints are reported and properly documented within the prescribed reporting time frame. For AEs/SAEs, ensure that they are consistent with all data collected and information in source documents; 5. Responsible for feedback on problems in the monitoring process to ensure that researchers complete data entry and answer questions within the expected time; 6. Work closely with contract research organizations to ensure that quality issues identified during routine monitoring visits, QA audit visits and other types of visits are addressed and that relevant corrective and preventive actions (CAPAs) are completed; 7. Responsible for the allocation of relevant documents, materials and drugs of the project, and communicate with the project manager in a timely manner about safety, materials, time and financial budget; 8. As the external representative of the company and customers, timely transmit important information of the company and customers to researchers, cultivate and maintain good relations with researchers; Good at coordinating the relationship and conflict between various projects; 9. Check the integrity of research documents to ensure that document preservation requirements are met, including keeping them in a safe place at all times; Review and sign all routine visit reports and other TMF documents for the project;
Job requirements: 1. Bachelor degree or above in clinical medicine, pharmacy or related majors, and academic qualifications with systematic professional training can be relaxed; 2. 2-1 years of clinical monitoring experience in oncology drugs, familiar with the workflow of I and II clinical trials; 3. Have the ability to discover various problems in the process of drug clinical trials, rigorous and standardized drug clinical trial monitoring and promotion capabilities; 4. Excellent communication and coordination skills, good communication with researchers, contract research organizations, laboratories, suppliers; 5. Meticulous work, responsible, patient, able to carefully consult relevant information, with certain writing skills; 6. CET-6 or above, with written language ability, proficient in operating the professional system of English interface.
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