1. Assist QC manager and/or project manager to develop project quality control plan to ensure clinical trials are performed in accordance with GCP, SOP and related regulatory requirements.

2. Assist QC manager to develop and update QC SOPs and instruction manual.

3. Complete the project quality control independently according to the quality control plan, and ensured the implementation of the project in accordance with relevant laws and regulations, GCP, SOP and customer requirements.

4. Record all quality control findings and discuss with relevant responsible personnel to provide solutions. Finish QC report and follow all Action until problem is solved and offer advice to CRA.

5. Participate in the training of QC, and prepared relevant training documents.

1. Major in medicine, bachelor's degree

2. At least 2 years of clinical research experience

3. Good English (writing and reading)

4. Familiar with GCP, ICH-GCP and other relevant regulations

5. Familiar with office and other skills

6. Good communication and presentation skills

1. Assist in the preparation of clinical trials;

2. Assist in contacting the ethics committee of the institution;

3. Assist investigators to explain the trial procedures to patients and obtain informed consent;

4. Communicate with investigators, sponsors or CRO companies when necessary;

5. Complete the report of SAE under the guidance;

6. Assist the investigators to fill in, input and answer CRF forms under the guidance, and complete the file management according to the project;

7. Assist investigators to screen potential patients and urge them to join the group;

8. Assist in supervision and inspection ;Prepare and provide all required documents for the sponsor.

1. Bachelor degree or above, major in clinical medicine, nursing, pharmacy, etc.

2. Over 1 year nursing experience is preferred;

3. Familiar with the working process of the hospital, have affinity and strong communication and coordination ability;

4. Self-motivated, strong sense of responsibility, proactive, careful and rigorous.

1. Develop CRA annual training plan together with training manager.

2. Conduct CRA training according to the training plan, including relevant training PPT and other documents.

3. Assist the training manager in development and implementation of training assessment methods.

1. Major in medicine, bachelor's degree

2. At least 3 years of clinical trial experience

3. Good English (reading and writing)

4. Familiar with GCP, ICH-GCP and other relevant regulations

5. Familiar with office software, especially Power Point

1. Responsible for investigation, selection and provision of relevant information of site investigators. Provide test related information in time according to test progress.

2. Organize, prepare and attend the investigators' meeting and make corresponding minutes at the meeting, responsible for the liaison and reception of site investigators.

3. Conduct comprehensive management of sites, strictly follow the GCP, SOP, and Chinese laws and regulations, and complete the selection, start-up, routine monitoring and closure of the site on time within the project plan time limit.

4. Timely complete high-quality site visit report.

5. Assist the research center in reporting AE/SAE and follow up.

6. Ensure the safety and interests of the subject by verifying the informed consent process.

7. Ensure the authenticity, accuracy and completeness of the data through the verification of original data and the management of case report/data inquiry form.

8. Manage the study materials at sites, including IPs, study documents and related test equipment.

9. Responsible for discussing with the main investigators of the sites about clinical trial agreements 

10. Coordinated the preparatory work before the inspection of the site, complete the feedback of the inspection report of the site, formulated the rectification plan, and completed the work in the rectification plan on time.

11. Provide training for investigators on protocol, GCP, CRF, etc.

12. Provide the site, local project team and management with the latest information about the trial.

13. Develop good cooperative relations with investigators.

14. Cover all other duties of the supervisor and be able to deal with emergency emergencies in a timely manner, and be the main emergency backup candidate for CRA and projects.

1. Bachelor degree or above in clinical or pharmaceutical related maojor.

2. At least 5 years of clinical trial experience in pharmaceutical enterprises or CRO.

3. Proficient in various Microsoft office software.

4. Proficient in English; able to independently consult relevant literature and materials; able to write English project progress report and QC report. Be able to communicate and communicate with the bid staff in good English.

5. Clear written and oral communication skills, good at active and active communication;

6. Good at communicating with different types of customers and able to establish good relationships;

7. Excellent team organizing ability/project management skills;

8. Strong problem solving ability and emergency plan management ability;