Major Responsibilities and Duties:

1. Participates in the development of clinical trial documents in collaboration with the project manager.

2. Identifies and selects investigators/sites in collaboration with the project manager.

3. Prepares / collects all documents needed prior to study initiation.

4. Performs study feasibility visits in the investigational sites.

5. Organizes / participates in study site initiation visit in which are provided scientific and technical knowledge concerning the study procedures and its organisation.

6. Ensures monitoring follow up:

1) Maintain the relationship with the investigational site.

2) Follow up of trial progress and quality control of data (source document check).

3) Documentation of protocol violations, adverse events and premature treatment cessation.

4) Identification and resolution of all problems: logistical, methodological, human technical, which occur during the trial.

5) Management of the local trial files.

6) Management of the investigator’s trial file.

7) Management of trial related logistics.

8) Detection and reporting of deviations, finding and implementing corrective measures.

7. Provides timely monitoring reports for all visits / contacts in appropriate reports.

8. Performs study close out visits to close investigational site.

9. Prepares, organizes and participates in investigator’s meetings.

10. Manage study TMF filing and archiving.

11. Participates in internal & external education and training.

Qualifications：

1. Bachelor’s degree and above.

2. Major in clinical medicine, pharmacy and biology or relevant.

3. Have 1-2 years of relevant monitoring experience in clinical trial, and have knowledge reserve of clinical trial management specification (GCP).

4. Strong communication and coordination skills with internal /external clients.

5. strong team spirit, sense of responsibility, proactive, careful and meticulous.

6. Good computer skills, including proficiency in Microsoft Word, Excel and PowerPoint.

7. Good oral and written communication skills.

8. Good organization and problem-solving skills.

9. Have a talent with effective time management.