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