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Clinical Research Associate

Responsibilities:

1 Conduct on-site clinical monitoring, which includes reviewing documentation, ensuring accurate data recording, verifying patient data, and ensuring that the trial protocol is in compliance with ICH-GCP guidelines and RealData's and our sponsor's SOPs.
2 Perform on-site visits, including site qualification, initiation, monitoring, and closeout visits.
3 Identify and recruit investigators.
4 Assist in the investigator meeting, including preparation, presentations, problem resolution, and follow-ups.
5 Ensure the timely submission of protocol and consent documents for EC/IRB approval.
6 Maintain all study related files and documentation.
7 Maintain regular contact with study sites to ensure protocol/GCP compliance.
8 Motivate investigators in order to achieve recruitment targets.
9 Complete study status reports accurately and on time.
10 Inform the project manager or senior CRA and other project team members of the study's progress.
11 Deal with CRF queries in a timely manner.
12 Ensure that drugs are stored properly and that they are all accounted for.
13 Participate, if requested, in the preparation and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines, and elements of the final report.
14 Ensure that files are properly archived upon completion of a study.
15 Lead projects based on the sponsor's needs.
16 Coach CRA I and the CRA assistant.

Qualifications:

1 A bachelor's degree in a medical, health, or science related area (MS degree preferred).
2 Minimum of 1 - 2 years of clinical trial management experience.
3 Knowledge of SFDA regulations and ICH-GCP guidelines.
4 General knowledge of clinical and laboratory terminology.
5 Good problem solving and analytical skills.
6 Computer literacy is desirable.
7 Strong spoken and written English communication skills.
8 Must be able to travel if required.

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