QA for Clinical Quality Specialists

Responsibilities

1. Create, organize, and implement a quality control plan, as well as conduct quality control inspections on clinical research projects to ensure that trial protocol, standard operating procedures (SOP), and CAP-related quality system requirements are met.

2. Develop quality SOP and requirement document systems in accordance with the CAP system.

3. Train all clinical staff on Good Clinical Practice (GCP) or ICH-GCP, as well as relevant laws and regulations, on a regular basis.

4. Be familiar with and understand the national human genetic resources policy's laws and regulations on the legal requirements of human genetic resources for heritage-related samples, etc.

5. Review the results of indoor quality control and the monthly quality control review, and assist the lab director with regular verification.

6. Assist in the maintenance of CAP certification and the clinical laboratory certification system.

7. Maintain and update the system's SOPs and related systems; supervise and coordinate the management of SOPs (the processes of generation, update, review, approval, and filing) to ensure compliance with the CAP system standard procedures.

8. On a system-wide basis, manage personnel qualifications, archives, experimental records, and project-related documents and archives.

9. Be in charge of other aspects of clinical quality management.

Qualifications

1. Master's degree or above in clinical medicine, public health and preventive medicine, clinical pharmacy, medical laboratory technology, medical experimental technology, biological science, biotechnology, etc.

2. You must be fluent in English listening, speaking, reading, and writing (English CET level 6 and above), as well as be able to translate and speak English fluently.

3. You must be strict and meticulous in your pursuit of exceptional self-learning ability.