北京招聘

Overall Job Purpose:

The Senior Clinical Research Associate (SCRA) has the responsibilities for the successful delivery of the assigned clinical research projects or tasks within his/her defined territory under the supervision of the (Associate) Clinical Research Manager (CRM) / (Associate) Clinical Research Director (CRD) or equivalence. The SCRA should work independently and would be expected to be the functional expert on the CRA role and could coach junior level CRAs. Responsibilities of SCRA include performing clinical on-site monitoring activities (including selection, initiation, monitoring, closeout of investigational sites, etc), participating in the project management and taking the lead CRA role in assigned projects.

1. Key Accountabilities
1.1 Site Management and Project Management
· Manage the assigned tasks or clinical projects in 100% compliance with ICH-
GCP, relevant SOPs, Local Regulations, other applicable laws and guidelines,
and within the agreed timeline, including but not limited to:
Ø Building relationships with investigators and site staff.
Ø Conducting study feasibility survey and site selection.
Ø Preparing required regulatory and IRB/IEC submissions.
Ø Providing training to study staff on conducting the project.
Ø Conducting local investigator meetings, study nurse/CRC training, and site Initiation.
Ø Performing monitoring visits according to the approved Monitoring Plan.
Ø Managing site Investigational Product (IP) supply management.
Ø Conducting source data/document verification (SDV) in compliance with the Monitoring Plan and data review timelines.
Ø Assisting and ensuring site staffs complete CRFs and answer data queries within the timeline defined in the Monitoring Plan.
Ø Completing monitoring visit reports and required follow-up actions.
Ø Ensuring compliance of pharmacovigilance and drug accountability.
Ø Being responsible for the completeness and quality of the on-site files.
Ø Identifying and resolving or escalating any issues to PM or (A)CRM/ (A)CRD in a timely manner.
Ø Closing out study sites on completion of the project, and ensuring no outstanding open issues.
Ø Maintaining and archiving study documentation and correspondence.
Ø Preparing and attending audit and inspection as needed.
Ø Acting as mentor and role model for other CRA team members to ensure study specific training for CRAs.
Ø Acting as a Lead CRA in assigned projects.
Ø Performing co-monitoring visits with junior CRAs or as required.

1.2 Relationship Management
· Contribute to the establishment of a strong team spirit.
· Establish and maintain effective working relationships with other internal
departments, including but not limited to: Medical Affairs, Regulatory Affairs,
etc.
· Develop working relationships with regulatory authorities and IRB/IEC personnel
within the constraints of any local guidelines and regulations.
· Support the identification of new client relationships, and further develop
existing relationships with external personnel, including but not limited to:
Ø Personnel from client companies / potential client companies.
Ø Investigators & site staff.
Ø Other institutional staff.
Ø Relevant healthcare professionals.

2. Job Requirements
2.1 Skills
· Excellent communication and presentation skills.
· Good working knowledge of relevant software such as MS-office (Excel, Word and
PowerPoint, etc).
· Strong attention to details.
· Ability to successfully work in a team environment.
· Sound problem solving skills.
· Ability to prioritize multiple tasks and achieve project timelines.
· Able to take initiative and work independently.
· Effective time management in order to meet daily metrics or team objectives.
· Can travel frequently, up to 60%.

2.2 Education
· Bachelor degree or above, majoring in medical, nursing, pharmaceutical or other
bio-science related area.

2.3 Language Skills
· Excellent written and oral skills in both English

2.4 Minimum Work Experience
· Experience of medical science related works.
· Over 2 years experience on oncology, global study experience is required.
· Demonstrating superior monitoring skills and sound independent professional
judgment.

Clinipace Clinical Research，一个基于科技的全球性全方位服务的数字化合同研究组织（dCRO）。我们开创性的开发了依靠技术创新的CRO服务模式，以满足风险投资支持的，中型的战略性制药，生物技术公司以及医疗器械公司的研发需求。

借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。

Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。

我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。

Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。

因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。

最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.

公司主页：*************************

最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com