登录/注册我是招聘方 免费发布职位
PPD百时益-CRA临床监查员
10-20K/月广东省-广州/本科及以上/1-3年
应洁一周前来过
赛默飞世尔科技（中国）有限公司
职位详情
岗位职责
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:
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Key responsibilities
• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to prove that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.
Keys to Success
Education and Experience:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Knowledge, Skills and Abilities:
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Good interpersonal skills.
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, 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:
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Key responsibilities
• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to prove that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.
Keys to Success
Education and Experience:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Knowledge, Skills and Abilities:
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Good interpersonal skills.
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, 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.
任职要求
无
相似职位
微信登录/注册
验证码登录/注册
公司信息
赛默飞世尔科技（中国）有限公司
- 上海
- 无
- 临床医疗服务、生物技术
- 外企
- 不需要融资
赛默飞世尔科技公司(Thermo Fisher Scientific)是全球科学服务领域的领导者（纽约证交所代码：TMO），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。
