工作职责：

CRA1/CRA2

任职资格：

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