临床试验助理
赛默飞世尔科技(中国)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:多元化业务集团公司
职位信息
- 发布日期:2024-05-11
- 工作地点:上海·黄浦区
- 工作经验:1年
- 学历要求:本科
- 职位月薪:6-9千·13薪
- 职位类别:临床研究员
职位描述
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Summarized Purpose:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document. Supports training of new staff and participates in departmental initiatives to support process improvements/enhancements.
Discover Impactful Work:
Clinical Research Group is dedicated in improving health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our dedicated, forward-thinking and upbeat teams.
Key responsibilities:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned.
Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers.
Provides system support (i.e. GoBalto & eTMF).
Supports RBM activities.
Performs administrative tasks including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
Supports scheduling of client and/or internal meetings with completion of related meeting minutes.
Reviews and tracks local regulatory documents.
Transmits documents to client and centralized IRB/IEC.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Maintains vendor trackers.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
May attend Kick off meeting and take notes when required.
Keys to Success:
Education
Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities
Responsible for adhering to Good Clinical Practices, country specific regulations, CRG services /Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
Ability to work in a team or independently as required
Ability to handle multiple tasks efficiently
Ability to analyze project-specific data/systems to ensure accuracy and efficiency
With flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
Ability to attain and maintain a good understanding of applicable Country Regulations, ICH and organization/Client SOPs and WPDs and closeout
Strong English language and grammar skills and proficient local language skills as needed
Strong IT skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Ability to complete CRG clinical training program
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, ***, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Summarized Purpose:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document. Supports training of new staff and participates in departmental initiatives to support process improvements/enhancements.
Discover Impactful Work:
Clinical Research Group is dedicated in improving health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our dedicated, forward-thinking and upbeat teams.
Key responsibilities:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned.
Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers.
Provides system support (i.e. GoBalto & eTMF).
Supports RBM activities.
Performs administrative tasks including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
Supports scheduling of client and/or internal meetings with completion of related meeting minutes.
Reviews and tracks local regulatory documents.
Transmits documents to client and centralized IRB/IEC.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Maintains vendor trackers.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
May attend Kick off meeting and take notes when required.
Keys to Success:
Education
Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities
Responsible for adhering to Good Clinical Practices, country specific regulations, CRG services /Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
Ability to work in a team or independently as required
Ability to handle multiple tasks efficiently
Ability to analyze project-specific data/systems to ensure accuracy and efficiency
With flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
Ability to attain and maintain a good understanding of applicable Country Regulations, ICH and organization/Client SOPs and WPDs and closeout
Strong English language and grammar skills and proficient local language skills as needed
Strong IT skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Ability to complete CRG clinical training program
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, ***, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
公司介绍
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
About Thermo Fisher Scientific China
Thermo Fisher Scientific (China) Co., Ltd has been operating in China for over 35 years. Headquartered in Shanghai, Thermo Fisher Scientific China has branch offices in Beijing, Guangzhou, Hong Kong, Chengdu, Shenyang, Xi’an, Nanjing, Wuhan, Jinan, and Dongguan with around 5,000 employees. Our products mainly include analytical instruments, laboratory equipment, chemical reagents, consumables, software and more; providing comprehensive laboratory solutions and serving customers across various industries.
In order to meet the local needs in China, we have established 8 manufacturing sites in Shanghai, Beijing, Suzhou and Guangzhou respectively. We also have 6 application centers and demo labs across the country which bring world-class technology and products with application development and training services to local customers. Lastly, we have the China Innovation Center in Shanghai and Suzhou, with over 100 scientists & engineers and more than 100 patents. China Innovation Center focuses on research and development supporting key vertical markets and develops products according to local demands with global advanced technologies. We have a nationwide maintenance network and China service training team, including over 2,800 professionals directly providing services for customers.
We are committed to enabling our customers to make the world healthier, cleaner and safer.
赛默飞世尔科技简介
赛默飞世尔科技是科学服务领域的世界领导者。公司年销售额超过300亿美元。
我们的使命是帮助客户使世界更健康、更清洁、更安全。我们帮助客户加速生命科学领域的研究、解决在分析领域所遇到的复杂问题与挑战、促进医疗诊断和治疗的发展、提高实验室生产力。
我们全球超过80,000名赛默飞员工将借助于一系列行业领先的品牌Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific、Unity Lab Services和Patheon,为客户提供领先的创新技术、便捷采购方案和全方位服务。
赛默飞世尔科技中国简介
赛默飞世尔科技进入中国发展已超过35年,在中国的总部设于上海,并在北京、广州、香港、成都、沈阳、西安、南京、武汉、济南、东莞等地设立了分公司,员工人数约为5000名。我们的产品主要包括分析仪器、实验室设备、试剂、耗材和软件等,提供实验室综合解决方案,为各行各业的客户服务。
为了满足中国市场的需求,现有8家工厂分别在上海、北京、苏州和广州等地运营。我们在全国还设立了6个应用开发中心以及示范实验室,将世界级的前沿技术和产品带给中国客户,并提供应用开发与培训等多项服务;位于上海和苏州的中国创新中心,拥有100多位专业研究人员和工程师及100多项专利。创新中心专注于垂直市场的产品研究和开发,结合中国市场的需求和国内外先进技术,研发适合中国用户的技术和产品;我们拥有遍布全国的维修服务网点和特别成立的中国技术培训团队,在全国有超过2800名专业人员直接为客户提供服务。
我们致力于帮助客户使世界更健康、更清洁、更安全。
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
About Thermo Fisher Scientific China
Thermo Fisher Scientific (China) Co., Ltd has been operating in China for over 35 years. Headquartered in Shanghai, Thermo Fisher Scientific China has branch offices in Beijing, Guangzhou, Hong Kong, Chengdu, Shenyang, Xi’an, Nanjing, Wuhan, Jinan, and Dongguan with around 5,000 employees. Our products mainly include analytical instruments, laboratory equipment, chemical reagents, consumables, software and more; providing comprehensive laboratory solutions and serving customers across various industries.
In order to meet the local needs in China, we have established 8 manufacturing sites in Shanghai, Beijing, Suzhou and Guangzhou respectively. We also have 6 application centers and demo labs across the country which bring world-class technology and products with application development and training services to local customers. Lastly, we have the China Innovation Center in Shanghai and Suzhou, with over 100 scientists & engineers and more than 100 patents. China Innovation Center focuses on research and development supporting key vertical markets and develops products according to local demands with global advanced technologies. We have a nationwide maintenance network and China service training team, including over 2,800 professionals directly providing services for customers.
We are committed to enabling our customers to make the world healthier, cleaner and safer.
赛默飞世尔科技简介
赛默飞世尔科技是科学服务领域的世界领导者。公司年销售额超过300亿美元。
我们的使命是帮助客户使世界更健康、更清洁、更安全。我们帮助客户加速生命科学领域的研究、解决在分析领域所遇到的复杂问题与挑战、促进医疗诊断和治疗的发展、提高实验室生产力。
我们全球超过80,000名赛默飞员工将借助于一系列行业领先的品牌Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific、Unity Lab Services和Patheon,为客户提供领先的创新技术、便捷采购方案和全方位服务。
赛默飞世尔科技中国简介
赛默飞世尔科技进入中国发展已超过35年,在中国的总部设于上海,并在北京、广州、香港、成都、沈阳、西安、南京、武汉、济南、东莞等地设立了分公司,员工人数约为5000名。我们的产品主要包括分析仪器、实验室设备、试剂、耗材和软件等,提供实验室综合解决方案,为各行各业的客户服务。
为了满足中国市场的需求,现有8家工厂分别在上海、北京、苏州和广州等地运营。我们在全国还设立了6个应用开发中心以及示范实验室,将世界级的前沿技术和产品带给中国客户,并提供应用开发与培训等多项服务;位于上海和苏州的中国创新中心,拥有100多位专业研究人员和工程师及100多项专利。创新中心专注于垂直市场的产品研究和开发,结合中国市场的需求和国内外先进技术,研发适合中国用户的技术和产品;我们拥有遍布全国的维修服务网点和特别成立的中国技术培训团队,在全国有超过2800名专业人员直接为客户提供服务。
我们致力于帮助客户使世界更健康、更清洁、更安全。
联系方式
- 公司地址:浦东新区新金桥路27号 (邮编:201206)
- 电话:15002183771