Location:

Beijing, Shanghai, Guangzhou, Chengdu, Wuhan

Description:

The CRC often handles the bulk of the daily study activities and plays a key role in the study conduct and management. The CRC is frequently responsible for organizing the documentation and files pertaining to a study and for coordinating the activities of the investigators and the study participants.

The responsibilities of the CRC may include:

• To initiate, monitor and close-out clinical trials in accordance with all relevant GCP standards and regulations;
• To record and archive properly all clinical trial related activities;
• To complete and review Case Report Forms (CRF) and ensure their validity, accuracy and integrity;
• To assist in the management of clinical trial product and related documents.

Requirements

• Bachelors degree or higher in medical, pharmaceutical, nursing or related field, preferably with 1 year working experience in hospital;
• Knowledge of medical terminology and clinical patient management;
• Good oral and written skills in English;
• Excellent computer knowledge of Windows operation system, MS Office software and Internet applications;
• Good interpersonal and organizational skills;
• Ability to work both independently and work within a team;
• Knowledge of ICH-GCP, and/or CRA experience is a plus.

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Location:

Frequent travel required

Description:

Support clinical trials in the role of Clinical Research Monitor (Clinical Trial Monitor) to include, but not limited to, the following responsibilities:

• Coordinate effective communication between Investigative sites, as well as study Management teams;
• Manage multiple investigational sites across China;
• Ensure that investigational sites maintain requisite regulatory and study specific documentation and are aware of their obligations;
• Ongoing supervision of investigative sites to assess compliance with protocol, sponsor, GCP and regulatory requirements in order to ensure the safety of subjects and accuracy of data;
• Conduct pre-study, site initiation, interim monitoring, and study closeout visits and complete associated reporting requirements in accordance with SOPs;
• Review Case Report Forms (CRF), including electronic data capture (EDC), and verify completeness and accuracy via source document verification activities;
• Review patient recruitment strategies and enrollment plans;
• Prepare study reports (e.g. Severe Adverse Event, protocol deviation reports, etc.);
• Audit all study related documents to ensure regulatory compliance;
• Provide study status reports in an accurate and timely manner to the study management team.

Requirements

• Minimally must completed four year college degree in nursing/medical science, with at least 2-3 years of working experience in a related field;
• Dependable, stong work ethic, willing to work overtime, willingness to travel up to 80%, ability to work independently and make decisions as necessary;
• Well-organized, able to multi-task and handle large volume studies; detail oriented; work efficiently;
• Good interpersonal/communication skills-ability to work with strong personalities;
• Good listener;
• Working knowledge of medical science (cancer preferred) and laboratory sciences; understand hospital setting and structure; ability to work with different departments within the hospital (laboratory, radiology department, ECG department, pharmacy, medical record, pathology lab, etc);
• Basic understanding of clinical trial designs and statistic analysis;
• Excellent computer skills (Word, Excel, Internet);
• Good command of oral and written English;
• Ability to grasp new skills quickly; problem solver.

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