北京招聘

在远程临床研究监察中心(Centralized Clinical Operation)模式下，参与global / regional 大型临床研究，并对以下等方面提供远程支持。

 

- 对职责范围内的Site和临床试验的执行情况 进行远程集中管理和监控，主要是通过Site Pack等工具来整理汇总Site及临床试验项目的各项信息，从而能对其有全面的了解

- 结合Clinical Study的试验方案和目前的进展状况，对后续的CRA Site Visit做详细的规划和重点事项的安排

-利用QIMS所提供的系统，对临床项目中的重点数据进行及时审查和监控（AI Compliance/Missing Page/Aging Query...),如有需要（Risk alert），及时安排CRA跟进相应问题的解决

-Review clinical study相关文件，协助管理eTMF文档.

 

职位要求：

1.5年以上CRA/CRC 等临床研究领域相关工作经验，或具有相关领域知识背景，本科以上学历。

英语六级或具有第二语言特长。

良好的沟通能力

熟练使用office相关办公软件

职位特点:

- 不需要出差

- 能够参与到Global/Regional 大型临床研究项目中，有机会与国外的同事进行相互交流

- 可以提高临床研究管理和整体把控能力以及全局观的思考能力

- 全新的临床研究模式，领先的临床试验管理方式及更多的学习机会

4类

PURPOSE

Apply clinical research expertise to provide project related assistance across complex and multiple project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

RESPONSIBILITIES

Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines

Establish and maintain effective project/ site communications

Create and maintain relevant project documents// trackers

Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information

Review, evaluate and recommend modifications to designated processes

Oversee and participate in document management (creation, review, maintenance, storage, as applicable)

Participate in (study) team meetings and implement action items

Collaborate with the project lead/team members in creation/review of study documents

Act as point of contact for assigned deliverables for specific customers or projects

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 to relevant stakeholders and/or line manager.

 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements;

     i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related systems and software utilized in clinical operations.

Strong written and verbal communication skills including good command of English language

Results and detail-oriented approach to work delivery and output

Good problem solving skills

Good planning, time management and prioritization skills

Ability to handle conflicting priorities

Attention to detail and accuracy in work

Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Proven ability to work on multiple projects balancing competing priorities Good leadership skills

Ability to work across cultures and geographies with a high awareness and understanding of cultural differences

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor's degree in life sciences or related field and min 3 years with relevant clinical research experience; or equivalent combination of education, training and experience

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
If that is your passion, we have a place for you.