长沙招聘

Responsibility Areas and Authority

1. Carry out regular internal quality assurance checks concerning the following:
？ Patient Files: general QA checks such as GCP compliance, compliance with the CCBR SOPs, use of the correct CCBR patient file pages
Audits to check if the protocol procedures are followed and if subject safety and data integrity is taken into account.
？ Investigator Files
？ Site facilities e.g. DXA, X-ray, Medication storage room, Laboratory, Height & Weight, general use of the Booking System, etc.

2. Work closely with sponsor representatives. Ensure that monitoring issues are addressed in a timely fashion.

3. In case of sponsor audits or regulatory inspections, assist the study staff in preparation; be present during audit or inspection and follow-up/corrective action as proposed during the audit or inspection.

4. Carry out internal quality assurance checks for ad-hoc quality aspects communicated by Director of QA

5. Ensure that new staff are trained (CCBR Basic training, job-function training, GCP training and study-specific training) within the appropriate time-lines.

6. Ensure that already-employed staff are re-trained on an ongoing basis when needed, either by carrying out the training herself (e.g. GCP training) or facilitating colleague-to-colleague training at CCBR Beijing or by arranging training with Director of QA where necessary.

7. Ensure that all staff are trained and updated in PharmaReady.

8. Ensure that User Authentification is updated for all employees.

9. Ensure that administrative documents are in place and updated if necessary, e.g. Organisation charts, employee contracts, job descriptions, CVs, medical licences/authorizations, certificates etc.

10. Provide general day-to-day QA support to the clinic staff, with support from the Director of QA

11. Provide regular, ongoing feedback to the Director of QA on ongoing QA activities carried out. In connection with this, audit reports, follow-up/corrective action plan, when needed are to be made and sent to the Director of QA as well as Managing Director of CRC, CCBR Beijing.

CCBR—全球***大SMO集团，于1992年在丹麦成立，在全球17个国家有40多个临床研究中心。CCBR一贯秉承质量为本的理念，提供一流的科学专业知识服务。
西斯比亚（北京）医药技术研究有限责任公司是CCBR在中国区的子公司，创办于2005年9月。西斯比亚（北京）是国际临床研究中心协会（SCRS）董事会成员、中国GCP联盟合作成员及中国SMO协作组***届理事会成员。
目前西斯比亚（北京）在中国拥有600多名CRC，覆盖全国近120个主要城市。

新候选人的隐私声明

当您提交信息以查询或申请临床与基础研究中心（北京）有限公司的职位空缺时，（地址：中国北京市昌平区生命园路 29 号中关村生命科学园生物科技创新大厦 C 座 1 楼，邮编：102206）（以下简称“CCBR”）我们将确保您的数据得到安全且保密的处理。
您的信息最初将由 CCBR 在中国的人力资源部同事以纸质和/或电子形式处理，以评估和管理您对本公司工作岗位的咨询或申请。我们不会将您的个人信息传输至中国境外地区。
如果您申请成功，则您的数据会作为新的任职记录的一部分保留下来；如果不成功，则您的信息会依照 CCBR 保留政策的要求保留 2 年，以备出现其他职位空缺。 此后，您的信息将被安全销毁。
所处理的关于您的个人信息包括名字、姓氏、地址和联系方式、出生地点和日期、年龄、性别、教育程度、工作经历、语言技能。
您有权要求 CCBR 以准确、最新且不具误导性的方式处理您的个人信息。此外，您有权访问并更正您的数据，请求删除，限制您的信息处理的各个方面，或要求以数字形式向您或第三方提供您的信息的副本。您可以通过向以下地址发送电子邮件来行使您的权利或要求进一步了解我们如何处理您的个人信息： AES_CCBR_HR_China@globalaes.com