(Sr.) Clinical Research Associate- (Sr ) CRA / (Study Operations Specialist)
Role Description
职位描述
- Investigational Site management: To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. To monitor investigator sites in compliance with Green Valley SOPs, ICH/GCP and local regulations so that site performance targets are achieved and that the company‘s image with its external customers is enhanced.
研究中心管理：跨部门合作，进行研究中心的选择和确定。按照绿谷 SOP，ICH/GCP 和当
地法规要求，对研究中心进行监查，以确保研究中心的达成目标并提高公司对外部客户的形 象
- Project Management support: For outsourced study, to sit in Project core team to support Project Manager from the study operations perspective, including CRO management, central lab management, Drug management, quality control etc.
项目管理支持：对于外包的研究，作为项目管理的核心团队中的一员，从临床操作层面支持
项目经理的工作，包括 CRO 的管理，中心实验室的管理，药品管理，和质量控制等。
Organizational Relationships:
组织关系：
*Reports to the Director of Clinical Research
汇报给临床研究总监
*Dotted line (matrix) report to Project specific Project Manager/Leader
虚线汇报给特定的项目经理/负责人
Responsibilities
岗位职责
1. Investigational site management
研究中心的管理
- Responsible for all aspects of site management from site selection to study closeout. Complete the site visit reports according to the Monitoring plan and ensure all reports are well archived according to the Green Valley SOP.
从研究中心的选择到中心关闭，负责研究中心管理的所有工作。根据监查计划完成
中心访视报告，并确保所有完成的报告符合绿谷 SOP。
- Proactively manage investigational site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met
根据工作经验，积极管理研究中心的工作量，确保研究有效的进行，满足主要研究
目的
- Identify issues that may impact on the conduct of the study, inform the PI and site staff and ensure appropriate closure of all issues in a timely manner. Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.
发现可能会影响研究的进行的问题，需及时告知 PI 和中心人员并确保所有问题合理
解决。和 PI 以及中心人员一起，制定更正和预防措施并达成一致，来解决所有发生
问题。
- Ensure the source data are recorded appropriately, Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion.
保证原始数据记录得当，进行 SDV 确保临床试验数据及时提交数据管理
- Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant regulatory requirements.
保障受试者的安全得到保护，确保所有的安全问题根据相关法规要求正确的上报
- Train site staff on the protocol, protocol amendments and study relevant processes.
给中心人员进行研究方案，方案修正案和研究相关流程方面的培训。
- Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.
充分的理解研究产品，方案和治疗领域，可以和研究团队进行合适的讨论
2. Data Quality
数据质量
- Ensure that data monitored meets target quality standards.
确保监查数据满足目标质量标准
- Ensure that data is collected in a timely manner.
确保数据及时的收集
- Ensure data queries are resolved in a timely manner according to the required timeline
确保数据疑问按照要求的时间节点及时地解决
3. Documentation
文件归档
- Ensure all the site level documents have been archived according the relevant study plans and Green Valley SOPs.
确保所有中心的文件按照相关研究计划和绿谷 SOP 进行归档
- Maintain the Site Visit log and ensure all visits have been recorded accordingly.
建立中心访视表，并确保记录所有的访视
4. Project Management Support
项目管理支持
- Sit in Project core team and contribute to the team deliverables from Operations perspective. Write and collate project team meeting minutes.
作为临床项目管理团队的一员，从操作层面给予团队支持。撰写并整理项目会议纪
要
- Contribute to the vendor management, including CRO, Central lab, IxRS vendors etc.
参与供应商的管理，包括 CRO，中心实验室，IXRS 等
- Contribute to the drug supplying and management
参与药品的供应和管理
- Quality control of investigational site management for outsourced studies
外包研究的研究中心管理的质量控制
- Contribute to the patient recruitment strategy and ensure the recruitment plan is
met.
协助制定患者入组策略并确保符合入组计划
EDUCATION and EXPERIENCE:
教育背景和经历
1. Master/Bachelor’s degree in life science (clinical medicine and pharmacy preferred) and 2+ years relevant investigational site management experience in pharmaceutical development is required
生命科学（临床医学和药学相关专业）硕士/学士学位，2 年以上药物开发领域相关的
研究中心管理经验者
2. Strong technical experience with exposure to product development in pharmaceutical, biotech industries or CRO is highly preferred
在制药、生物技术行业及 CRO 公司有丰富产品开发技术经验者优先考虑。
3. Good knowledge of ICH Good Clinical Practice, relevant international and local regulations relating to Clinical Research
熟悉临床研究 ICH（GCP）和相关国际和当地的有关临床研究的法规要求。
4. Basic knowledge of oncology and/or hematology, or experience in early clinical development preferred.
具有肿瘤/血液学，或早期临床发展经验者优先
OTHER SKILLS and CHARACTERISTICS:
其他技能和特点
1. Strong interpersonal skills
良好的人际交往能力
2. Capable of working independently as well as in a team environment
独立工作能力和团队合作能力
3. Ability to handle multiple activities; work effectively under time constraints to meet deadlines
能处理多项工作；在有限时间内高效地完成任务
4. Professional communication skills, both verbal and written coupled with attention to detail
专业的沟通技巧，包括口头和书面并关注细节
5. Demonstrated work ethic, integrity and professional conduct
良好的职业道德、正直和专业行为