Clinical Monitor (CRA)
Negotiable
Job Description:
Selection of suitable researchers and research centers;
2. Independent supervision of the research center, including: document verification, ensuring accurate record of test data (SDV), and ensuring that the test follows the approved plan, SOP and relevant regulations;
3. Independent on-site visits, including center evaluation, center start-up, center inspection and center closure;
4. Assist researchers in the convening of meetings, including preparation, liaison, recording of meeting minutes, tracking and solving problems;
5. Ensure that the trial protocol and informed consent and other relevant information are submitted to the ethics committee in a timely manner;
6. Assist in the negotiation of clinical trial contract;
7. Maintain all records and documentation related to the study;
8, to promote the researchers to complete the subjects into the group;
9. Communicate the progress of the project and other relevant information with the project manager or senior supervisor and other members of the project team;
10. Timely completion of research progress reports that meet the requirements;
11. Verify that the experimental drugs are supplied, stored, distributed and recycled in accordance with standard operating procedures, and make corresponding records;
12, timely assistance to researchers to solve CRF data questions;
13. Ensure that all documents are correctly filed when the test is completed;
14. Complete other tasks assigned by the project manager.
Requirements:
1. Bachelor degree or above in medicine, pharmacy, nursing and other related majors, more than one year of clinical research related work experience is preferred;
2. Familiar with CFDA regulations and ICH/GCP regulations;
3. Knowledge of medicine and drug clinical trials;
4. Proactive team work spirit;
5. Good problem solving and analytical skills;
6. Good computer office software operation ability;
7. Preliminary English communication and writing skills;
8, can travel according to work needs.
Company address: Floor 4 and Floor 5 (1) of Building 3, Phase 3.1, Wuhan Optics Valley International Biomedical Enterprise Accelerator, 388 Gaoxin 2nd Road, Donghu New Technology Development Zone, Wuhan City
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