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. Independent 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. Assist and/or support project manager/line managers regarding study site management skills mentoring/coaching from site selection to study closeout, if applicable
14. Assist and/or support project manager regarding study team member training on the protocol, protocol amendments, study procedures and/or company processes
15. Assist and/or acting as project manager regarding project management activities under study requirements and/or company processes with appropriate guide or coaching in place
16. Participate in training and mentoring of new staff ensuring compliance with ICH/GCP, company SOPs and/or company policies, if applicable
17. Assist and/or contribute to process improvements, knowledge transfer and best practice sharing, if needed
18. Other works which line manager or company assigned

任职资格：

Education：
• Major in clinical medicine/nurse/ pharmacy/ pharmacological or other related, clinical medicine/nurse was preferred
• At least junior college education, bachelor’s degree and above was preferred. or other equivalent education background
Experience：
• At least 3 years or above clinical trial working experience in CRO/Pharmaceutical company or equivalent experience
• Candidates with clinical research experience in multinational pharmaceutical companies or multinational CROs was preferred