临床研究员Insourced CRA for top 5 pharma
丘以思（上海）医药信息咨询有限公司
- 公司规模：50-150人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-03-07
- 工作地点：北京-朝阳区
- 招聘人数：1人
- 工作经验：1年经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：8000-15000/月
- 职位类别：临床研究员
职位描述
职位描述：
Job Description
? Provides support to Project Team and Clinical Operations Team.
? Maintains working knowledge of protocols and Monitoring Plans for assigned projects.
? Demonstrates strong written and verbal communication skills.
? Serves as primary contact for assigned research sites.
? Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
? Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
? Ensures assigned sites are conducting studies according to protocol requirements and applicable regulations and guidelines.
? Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
? Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
? Verifies that written informed consent was obtained before each subject’s participation in the trial.
? Verifies that the investigator is enrolling only eligible subjects.
? Performs verification of source document s against Case Report Form/Electronic Data Capture entries to assure accurate and complete data. Ensures that any corrections are appropriately documented by authorized site staff.
? Issues and ensures timely resolution of all data queries.
? Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
? Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
? Ensures that sites have sufficient project specific supplies.
? Manages and motivates sites to meet study goals.
? Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
? Delivers quality written trip reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans.
? Attends and participates in team teleconferences and training.
? Attends investigator meetings.
? Participates in site audits, as requested.
? Makes recommendations for improvement in processes.
? May conduct site and study feasibility assessments.
? May be involved in the development of monitoring guideline and tools.
? Provides input into study documentation and monitoring worksheets.
? Uphold the confidentiality agreements with all clients and colleagues outside Clinipace Worldwide (CPWW).
? Work according to the CPWW Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.
? Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the CPWW time allocation system.
? Demonstrates flexibility and adaptability.
? Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
? Other duties as assigned by Lead Clinical Research Associate/Clinical Trial Manager/Project Manager and per project-specific requirements.
? May participate in delivering Clinical Monitoring portion of a bid defense presentation.
Requirement:
? At least 2 years CRA working experience in multinational pharmaceutical company or CRO
? Have global Phase III clinical trials experience.
? Familiar with clinical trail system.
? Good English skills, willing to learn, hard working.
? Candidate should be major in clinical medicine or pharmacy.
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Job Description
? Provides support to Project Team and Clinical Operations Team.
? Maintains working knowledge of protocols and Monitoring Plans for assigned projects.
? Demonstrates strong written and verbal communication skills.
? Serves as primary contact for assigned research sites.
? Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
? Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
? Ensures assigned sites are conducting studies according to protocol requirements and applicable regulations and guidelines.
? Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
? Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
? Verifies that written informed consent was obtained before each subject’s participation in the trial.
? Verifies that the investigator is enrolling only eligible subjects.
? Performs verification of source document s against Case Report Form/Electronic Data Capture entries to assure accurate and complete data. Ensures that any corrections are appropriately documented by authorized site staff.
? Issues and ensures timely resolution of all data queries.
? Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
? Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
? Ensures that sites have sufficient project specific supplies.
? Manages and motivates sites to meet study goals.
? Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
? Delivers quality written trip reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans.
? Attends and participates in team teleconferences and training.
? Attends investigator meetings.
? Participates in site audits, as requested.
? Makes recommendations for improvement in processes.
? May conduct site and study feasibility assessments.
? May be involved in the development of monitoring guideline and tools.
? Provides input into study documentation and monitoring worksheets.
? Uphold the confidentiality agreements with all clients and colleagues outside Clinipace Worldwide (CPWW).
? Work according to the CPWW Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.
? Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the CPWW time allocation system.
? Demonstrates flexibility and adaptability.
? Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
? Other duties as assigned by Lead Clinical Research Associate/Clinical Trial Manager/Project Manager and per project-specific requirements.
? May participate in delivering Clinical Monitoring portion of a bid defense presentation.
Requirement:
? At least 2 years CRA working experience in multinational pharmaceutical company or CRO
? Have global Phase III clinical trials experience.
? Familiar with clinical trail system.
? Good English skills, willing to learn, hard working.
? Candidate should be major in clinical medicine or pharmacy.
职能类别： 临床研究员
关键字： CRA Clinical Research Associate 临床研究员 临床检查员
公司介绍
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
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
联系方式
- Email：kding@clinipace.com
- 公司地址：地址：span广州