职位描述:

主要职能：

Key Objectives/Deliverables：

1. 根据试验方案、SOP、GCP和相关的当地法规的要求进行研究中心筛选、启动、监查和关闭访视。

2. 可同时负责多个方案、研究中心和治疗领域内的研究中心监查工作。

3. 根据每个研究中心的情况制定项目受试者的招募计划。根据项目需要与研究中心合作，调整、推动和跟踪受试者招聘计划，以提高招募进度的可预见性。

4. 对所负责的研究中心进行方案和研究相关的培训，与研究中心进行定期沟通以管理项目进行中的要求和问题。

5. 评估研究中心工作的质量和完整性，确定研究中心是否是按照方案和适用的法规进行研究，确定受试者的权益受到保护。将质量问题汇报给负责的PM和/或直线经理。

6. 通过追踪注册申报和批复、招募和入选、病例报告表（CRF）完成和递交、以及数据疑问产生和解决的情况，管理所负责研究中心的进展。

7. 创建和维护与研究中心管理、监查访视的发现以及行动计划相关的文件，递交访视报告和其他所需研究文件。

8. 负责相应研究中心的研究财务管理。

9. 与其他职能部门共同合作。

10. 对于公司外包项目，协助协调CRO、研究中心和服务商，建立并保持良好的关系。

11. 完成直线经理和/或项目经理分配的其他工作。

Key Responsibilities:

1. Perform site selection, site initiation, monitoring and close out visits in accordance with protocol, SOPs, GCP and applicable local regulations.

2. Responsible for sites monitoring related works in multiple protocols, sites and therapeutics areas.

3. Accountable for supporting development of project subject recruitment plan on a per site status. Work with site to adapt, drive and track subject recruitment plan in the line with project needs to enhance predictability.

4. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

5. Evaluated 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.

6. 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 solution.

7. 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 documentations.

8. Responsible for site study financial management.

9. Collaborate and liaise with study team members for project execution support as appropriate.

10. Assistant for cooperating with CRO, site and vender to build up good relationship.

11. Complete other tasks assigned by line manager and project manager.

任职条件:

1. 良好的临床研究相关知识，了解适用的法规要求，至少一年以上肿瘤项目经验。

2. 通过公司培训掌握方案相关的知识。

3. 良好的计算机使用技能，包括应用微软Word、Excel和PowerPoint等。

4. 良好的口头和书面沟通能力。

5. 良好的组织和解决问题的能力。

6. 与同事、经理、研究中心和服务商建立工作关系的能力。

7. 能始终遵循SOP要求。

Qualifications:

1. Good knowledge of clinical research and understanding of applicable regulatory requirements，at least 1 year of oncology experience.

2. Master the protocol related knowledge required through company training.

3. Good computer skills, including proficiency in Microsoft Word, Excel and PowerPoint

4. Good verbal and written communication skills.

5. Good organization and problem solving skills.

6. Effective time management skills, ability to handle conflicting tasks at the same time.

7. Ability to establish and maintain effective working relationships with colleagues, managers, research centers, and service providers.

8. Can always follow SOP requirements. Ability to think independently and improve process.