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临床研究协调员Clinical Research Coordinator(CRC) 始达(上海)医药科技有限公司 上海-浦东新区 6-8千/月 04-26

学历要求:中专|工作经验:无工作|公司性质:合资|公司规模:少于50人

Position objective:The Study Coordinator has the authority to run the protocol on a day-to-day basis. The Study Coordinator will have sufficient education, training, and resources available enabling them to perform in this role.Major responsibilities:1. Responsible for implementation as well as completion of protocol specific requirements.2. Provide accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements.3. Assist in the maintenance of all study related Case Report Forms, whether paper or electronic as well as know status of completion.4. Understand and abide by the ethical issues involved in human subjects research, adhering to the Federal Regulations governing research.5. Continuous monitoring of progress in terms of the status of the protocol, reporting back to assigned personnel, updating management staff as well, via weekly and / or other required reports.6. Monitor the overall day-to-day conduct of assigned protocols in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.7. Creates as well as utilizes charts, spreadsheets, and /or any other appropriate tools enabling the continued, accurate, up to date management of protocol related tasks.8. Responsible for all protocol specific closeout activities in conjunction with the Clinical Research Assistant assigned to the specific study.9. To participate in the recruitment and screening of research patients10. To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse eventsCompetency/Quality Requirement:1. Nursing Graduate or equivalent, preferably with nursing experience2. Strong project management skills, ability to manage project activities effectively3. Preferably with patient care working experiences with attention to details4. Excellent communication skills5. Willingness to take on new challenges and think with flexibility主要职责:1. 负责临床研究按方案要求实施;2. 在研究过程中,向团队成员提供准确、及时的信息;3. 协助维护所有与研究有关的CRF;4. 按照方案要求监察项目进展,并向相关人员报告;5. 参与受试者的招募和筛选;6. 与申办方保持密切的联系,参与患者入组、用药、实验室检查异常结果和不良事件报告等。任职要求:1. 护理学、医学、生命科学或相关专业中专以上学历;2. 良好的沟通技巧和独立工作能力;3. 熟悉上海三甲医院工作流程者优先。Position objective:The Study Coordinator has the authority to run the protocol on a day-to-day basis. The Study Coordinator will have sufficient education, training, and resources available enabling them to perform in this role.Major responsibilities:1. Responsible for implementation as well as completion of protocol specific requirements.2. Provide accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements.3. Assist in the maintenance of all study related Case Report Forms, whether paper or electronic as well as know status of completion.4. Understand and abide by the ethical issues involved in human subjects research, adhering to the Federal Regulations governing research.5. Continuous monitoring of progress in terms of the status of the protocol, reporting back to assigned personnel, updating management staff as well, via weekly and / or other required reports.6. Monitor the overall day-to-day conduct of assigned protocols in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.7. Creates as well as utilizes charts, spreadsheets, and /or any other appropriate tools enabling the continued, accurate, up to date management of protocol related tasks.8. Responsible for all protocol specific closeout activities in conjunction with the Clinical Research Assistant assigned to the specific study.9. To participate in the recruitment and screening of research patients10. To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse eventsCompetency/Quality Requirement:1. Medical School Graduate or equivalent with clinical research experience, preferably with oncology training2. Strong project management skills, ability to manage project activities effectively3. Preferably with 2 years clinical research or patient care working experiences with attention to details4. Good spoken and written English capabilities with excellent communication skills5. Willingness to take on new challenges and think with flexibility

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高级临床应用/临床应用经理 德记巴迪泰(上海)贸易有限公司 上海-虹口区 1-1.5万/月 04-26

学历要求:本科|工作经验:5-7年|公司性质:合资|公司规模:50-150人

岗位职责:一、产品使用及特殊应用场景的临床培训和技术指导。二、产品售前调机,装机调试,以及产品在使用中临床问题的技术解答及处理。三、重点客户和产品的推广会、学术会讲课,协同销售完成试剂项目开拓和维护。四、销售过程中的临床技术支持,协助完成销售指标,实现良性增长。五、收集,整理和分析客户及市场信息并在团队内进行分享;为销售工作提供建议。六、收集客户反馈,提高客户满意度,促进在线产品改进。七、代理商临床应用队伍的培养,提高区域内代理商人员临床应用水平。八、上级领导交代的其他工作。岗位要求:1、全日制专科及以上学历,硕士优先;2、医学检验或临床医学相关专业;3、5年以上POCT产品或检验科相关工作经验;4、丰富的产品相关知识储备、娴熟的操作处理问题能力、出色的推广演讲表达能力;5、具备一定的抗压能力、适应出差

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Manager of Upstream Manufacturing - B34 上海睿智化学研究有限公司 上海 1.2-2.4万/月 04-26

学历要求:本科|工作经验:|公司性质:外资(欧美)|公司规模:1000-5000人

Job Description:The upstream manufacturing manager position is available in Biologics Manufacturing Department at ChemPartner in Shanghai. As the manager of upstream manufacturing, you will report to Sr. Director, Head of Biologics Manufacturing. In this position, you will provide tactical leadership to the upstream manufacturing group and be responsible for upstream cell culture manufacturing performed in compliance with current good manufacturing practices (cGMP) required by CFDA, US FDA and EMA. You will collaborate with downstream manufacturing group, fill/finishing group, process development and other supporting departments to ensure upstream production goals are achieved according to project schedule.Qualifications:The ideal candidate will have a BS/MS degree in Biochemical Engineering, Chemical Engineering, Biochemistry or related field from an accredited college or university and a minimum of 5 years working experience in a cGMP environment. Extensive working knowledge in cell culture at pilot and/or commercial scale is required. Management experience with years of progressive experience in biologics manufacturing is a plus. The successful candidate must be a goal-oriented team player with excellent communication skills and adaptive to a quality and time-line driven work environment.The ideal candidate will also have demonstrated knowledge and qualification in:? Working knowledge of Current Good Manufacturing Practices (cGMP).? Technical knowledge of cell culture manufacturing processes, equipments, procedures and systems.? Previous experiences in cell culture scale-up, technology transfer including drafting production batch records, technology transfer and process qualification protocols etc., are highly desired? Hands-on experience in equipment, process qualifications and regulatory requirements.? Responsible for scheduling and coordinating the upstream manufacturing work to meet project timeline.? Familiar with deviation investigation, CAPA implementation and cGMP quality system.? Functioning as a team leader, coach, mentor, and managing direct reports.? Directing, supervising, coordinating, delegating and reviewing the work of assigned department personnel.? Excellent communication, organization and collaborative skills are essential. Ability to read, write and speak in English is required.

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免疫细胞高级研究员/肿瘤免疫治疗研究员 英普乐孚生物技术(上海)有限公司 上海-浦东新区 0.8-1.2万/月 04-26

学历要求:硕士|工作经验:|公司性质:民营公司|公司规模:少于50人

职责描述:1、协助技术总监完成肿瘤免疫等相关科研项目;2、从事CAR-T,DC疫苗的研发和操作;3. 阅读文献,自主设计实验路线;4. 独立的分析总结实验数据,提交简要报告并能进行会议汇报;5、撰写各类基金申请书,申请国家和地方基金资助;6、团队建设,培养后备人才。任职要求:1、免疫学或相关专业硕士或博士学历,有博士后工作经验或国外学习经验者优先;2、熟悉免疫系统关系紧密的肿瘤模型;3、熟练掌握肿瘤免疫学相关分子、细胞和动物实验技术,有病毒构建经验者优先;4、有独立思考,勇于创新并解决问题的能力;5、有团队工作精神。工作认真刻苦,对工作有强烈的责任感;6、较好的英语沟通表达能力。

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临床专员(临床分析) 宁波麟沣生物科技有限公司 异地招聘 0.4-1.3万/月 04-26

学历要求:本科|工作经验:1年|公司性质:民营公司|公司规模:150-500人

1.根据法律法规,进行临床试验项目的管理和质量控制,包括临床试验中心筛选、伦理报批、启动会组织、PI沟通、与CRO公司相关人员的沟通、质量控制与监督、结果统计与分析等工作;2.根据项目计划及进度表,确保项目按计划实施;3.检查并确保CRF中数据的合法性、准确性和完整性;4.及时沟通项目经理、申办者和研究者,确保临床试验符合GCP和SOP规范;5.定期总结和完成项目在各临床试验中心的相关报告任职资格:1.学历水平:医学、药学、护理学、生物学等相关专业,本科及其以上;2.技能要求:英语四级以上,具备一定的文献查询与提炼能力,掌握计算机办公软件;3.素质要求:具有优秀的沟通及团队合作能力、认知能力、学习能力、独立能力;4.其他要求:适应出差。

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临床试验项目经理 上海爱申科技发展股份有限公司 上海-浦东新区 5-8千/月 04-26

学历要求:本科|工作经验:|公司性质:民营公司|公司规模:50-150人

1.临床资料产品手册的编写与校订;2.培训资料的编写、更新和整理;3.产品注册临床方案及报告的准备;4.及时收集同类产品的、分析、汇总、建议;5.及时、准确地提供国内外最新医学信息及相关资料。任职资格1. 全日制本科以上学历,临床医学或相关专业;2. 具有医学专业基础知识,1年以上医院临床实践经验,具肿瘤治疗经验者优先;(优秀应届毕业生亦可考虑)3.了解行业特征及医院管理流程;4. 善于沟通,语言表达能力强,具有强烈的事业进取心及责任感;5.具有一定的计算机基础知识。

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生物样本/检测标本处理员 北京欧诺美医药科技有限公司 上海-金山区 4-7千/月 04-26

学历要求:大专|工作经验:|公司性质:民营公司|公司规模:50-150人

工作内容描述: 1、负责血液样本的离心和分装等前处理工作;2、负责处理样品的信息录入以及审核工作。任职要求:1、大专及以上学历,医药、生物或化学等相关专业,有一年以上实验室工作经验者优先;2、会基本电脑操作,熟悉Word和Excel文档编辑方法。3、要求工作认真、仔细,具有较强的工作责任心,能够承受较长的工作时间;4、家住金山,能接受灵活的上下班时间。

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体外诊断器械认证工程师助理 上海久顺企业管理技术服务有限公司 上海-浦东新区 0.6-1.2万/月 04-26

学历要求:大专|工作经验:2年|公司性质:民营公司|公司规模:50-150人

工资体制:专职为:具竞争力的底薪+优厚项目奖金。(1)本助理职位又名:体外诊断器械认证咨询师、体外诊断器械咨询师、体外诊断器械注册咨询师、体外诊断器械认证工程师、体外诊断器械认证咨询师、体外诊断器械注册专员。(2)本科以上学历。理工科专业背景,以生物工程,生物化学,微生物,生物医学工程,化学工程,电气、电子、机械、医疗器械等专业优先,1年以上体外诊断器械企业相关工作经验。(3)有ISO13485、CE认证咨询经验,或CFDA体外诊断器械注册经验、体系考评及生产许可证经验,或有研发经验、检验测试经验、审核经验、体系推行经验。或有ISO9001或其他体系标准认证咨询、审核经验、体系推行经验。(4)CET4级以上,CET 6级更佳。(5)勤奋,高度的工作热情,具有良好的职业操守。(6)能高效工作,学习能力强,肯花时间钻研和学习。(7)良好的口头表达能力和协调能力,良好的独立工作能力及团队合作精神。(8)良好的身体素质,有时需要出差。(9)勇于挑战高薪,和公司协同快速发展。 (10)有体外诊断器械或药品临床应用经验者优先。从2018年8月起本公司搬入新置办公室办公,地址:东方路800号宝安大厦15层,交通:地铁世纪大道站(2,4,6,9四条地铁均可直达)。

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IHCRA 上海康德弘翼医学临床研究有限公司 异地招聘 0.8-1万/月 04-26

学历要求:大专|工作经验:|公司性质:合资|公司规模:150-500人

General SummaryThe In House Clinical Research Associate I (IHCRA I) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. At the Senior level, the IHCRA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.Key Responsibilities: Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites. Utilizes the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked. Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines. Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements. Performs study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete. Documents site and Sponsor contact and study interactions in a timely and professional manner. Assists with resolution of investigational site/data queries. Liaises with project team members regarding study site issues. Provides quality review of the informed consent template. Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study. Follows up with sites for trial invoices and ensures CTMS is accurately updated to allow the timely processing of Investigator Payments. Performs other duties as assigned. Liaises with internal and external customers to meet project specific goals including participation in sponsor and project related meetings Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals Identifies, monitors, documents, and tracks out-of-scope activities.Supports Clinical Team Manager (CTM)/Country Start-Up Specialist (CSS) and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations. Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query Distribution to/from investigational sites. Proficient in the development and review of Informed Consent Form templates. May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents. Assists in the creation and maintenance of clinical project documents including, but not limited to Clinical Management Plans, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans under the guidance of the CSS/CTM. Supports the CTM/CSS/CRA to resolve internal and external clinical issues for client research projects managed by PRA. Interacts with site, clients, vendors and PRA functional areas as secondary project contact for site issues and questions. Supports CTM/CSS/CRA in the management of clinical budget and evaluation of study processes. Evaluates metric data to identify process improvements. Assists with managing and training staff.Manages time and project requirements based on study contract.Job Factors (Knowledge, Skills and Abilities)          Knowledge & Skills Demonstrates good working knowledge of PRA systems and work environment Demonstrates thorough knowledge of clinical research industry standards, practices, and regulations Exhibits good decision making skills utilizing all available resources for determining positive outcomes. Successfully interacts with both internal and external customers, representing the organization on specific projects.       Problem solving Fact Finding & Analysis Develops solutions to a variety of moderate to complex issues independently. Refers to established policies and practices for guidance.Impact  Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.Supervision Given/Received Works under only very general supervision. Work is reviewed throughout the process for soundness of judgment, accuracy, and adequacy. May be in a leadership/ mentoring role for a specific project.Qualifications             Education Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional             Experience 0 – 2 years of related experience prior experience using computerized information systems. Read, write, and speak fluent English; fluent in host country language required Minimum of 2 years of related experience Experience with PC-Windows, word processing, and electronic spreadsheets required. Knowledge of ICH and local regulatory authority drug research and development regulations required. Clinical trials support or pharmaceutical industry experience required.             Preferred Education and/or Experience            Experience leading a team in a clinical research environment preferred.

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临床监察员(CRA)---地区:上海 江苏康缘药业股份有限公司 上海 0.4-1万/月 04-26

学历要求:本科|工作经验:1年|公司性质:上市公司|公司规模:1000-5000人

岗位职责: 1、完成临床研究单位的调研筛选、协议谈判;2、召开临床试验各阶段会议,准备临床试验样品、资料等;3、负责临床试验的实施和监查,跟踪协调,确保试验按要求开展;4、及时妥善处理试验过程中发生的AE/SAE(AE是不良事件,SAE是严重不良事件);5、完成试验数据的核实及疑问答疑工作;6、跟进、处理临床试验过程中出现的问题,并及时汇报给上级领导。任职要求:1、大学本科及以上学历,医学专业、临床医学、临床药学、药学等关专业; 2、工作认真、有强烈责任心与敬业精神、能承受工作压力; 3、能接受长期出差。

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