依格斯(北京）医疗科技有限公司

Ø         Identify and recruit investigators.

Ø         Conduct on-site clinical monitoring which includes: document review, ensuring accurate data recording, verifying patient data, adherence to the protocol of a clinical trial in accordance with GCP/ICH guidelines, and Excel’s/sponsor’s SOPs.

Ø         Perform on-site visits, including site qualification, initiation, monitoring and closeout visits.

Ø         Assist investigator meeting including preparation, liaison, presentations, problem resolutions, and follow up.

Ø         Ensure timely submission of protocol / consent documents for EC/IRB approval.

Ø         Maintain all files and documentation pertaining to studies.

Ø         Motivate investigators in order to achieve recruitment targets.

Ø         Maintaining regular contact with study sites to ensure protocol/GCP compliance.

Ø         Communicate progress of study and relevant information to Project Manager/Sr. CRA and other project team members.

Ø         Complete accurate study status reports in time.

Ø         Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.

Ø         Deal with CRF queries in a timely manner.

Ø         Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.

Ø         Ensure correct archiving of files on completion of a study.

Ø         A Bachelors Degree in a medical, health, or science related area; MS degree preferred. 

Ø         Minimum of 2 years medical / science background and relevant experience; experience of clinical trial management would be preferable. 

Ø         Knowledge of SFDA regulations and ICH/GCP guidelines. 

Ø         General knowledge of clinical/ laboratory terminology. 

Ø         Good problem solving and analytical skills. 

Ø         Computer literacy desirable. 

Ø         Strong oral and written communication skills in English. 

Ø         Must be able to travel if required.