工作职责：

1. Conduct clinical site management related work according to company Standard Operation Procedures (SOP), Good Clinical Practice (GCP), and other authority laws and regulations
2. Conduct and/or assist with site for study filling, initial EC submission/ EC opinion responds, clinical study agreement negotiation and others according to protocol and company SOPs
3. Acting as the main line of communication between the sponsor and the investigator accordance with contracted scope of work
4. Conduct site selection (if applicable), site initiation, routine monitoring and close-out visits in accordance with contracted scope of work
5. If applicable, may be accountable for supporting developing project subject recruitment plan on a per site basis. Work with sites to adapt, driving and tracking subject recruitment plan in line with project needs
6. Conduct monitoring visits and site management activities for a variety of protocols, sites and therapeutic areas
7. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
8. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
9. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution, safety information submission etc.
10. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
11. Build awareness of features and opportunities of study to site
12. Collaborate and liaise with study team members for project execution support as appropriate
13. Other works which line manager or company assigned

任职资格：

Technical/skills Training • Basic GCP knowledge and International Conference on Harmonization (ICH) guidelines • Basic drug development related laws and regulations knowledge • Candidates with authority GCP training certificate was preferred Language Ability • CET-4 and above or equivalent fluent English in reading, writing and speaking Computer Literacy • Proficient with laptop • Familiar with Microsoft office software (Word, Excel, Power Point, etc.) or equivalent software familiar Others • Able to work at sites and frequently travel • Good communication skill • Good organization and problem-solving ability • Team-work spirit, ability to build and maintain efficient working relationships with colleagues, managers and customers, self-motivated was preferred