临床监查员cra(广州)

7 days ago

Guangzhou, Guangdong, China 上海诺为电子科技有限公司 Full time CN¥300,000 - CN¥600,000 per year

该职位来源于猎聘 职责描述: 1、Performing site evaluation, initiation, monitoring and close-out visits, plus maintaining appropriate documentation according to a project-specific monitoring plan, ICH-GCP, and applicable regulations. 2、Supporting the development of a subject recruitment plan.

3、Establishing regular lines of communication plus administering protocol and related study training to assigned sites.

4、Evaluating the quality and integrity of site practices – escalating quality issues as appropriate. 5、Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

6、Assist of country and/or site start up activities, including but not limit to country/site ICF development, preparation of IRB submission package, site contract and budget negotiation, and regulatory documents collection. 7、Perform the tasks assigned by line manager. 任职要求: 1、ABS (Bachelor of Science) degree in Life Sciences or a related field. Advanced degree is an advantage. 2、Familiar with all clinical operation activities throughout an entire clinical trial. 3、Excellent organizational and problem-solving skills. 4、Strong written and verbal communication skills in English. 5、Good computer literacy e.g., MS word, Excel, PowerPoint, internet.

Senior CRA also need; 6、 Time and priorities manage skill 7、 Good Mentoring skill

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