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職責(zé)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.