- 1年经验
- 本科
- 招2人
- 11-09 发布
职位描述
职位描述: *Job DescriptionBuild relationships with investigators and site staffParticipate in Investigator and other external or internal meetings as requiredArrange on-site visits and logistics (e.g. travel arrangements)Perform on site visits in accordance with the monitoring planConduct on-site study-specific training (if applicable)Perform site facilities inspectionMonitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violationsMonitor and maintain ICH-GCP complianceResponsible for the completeness and quality of the on-site filesRespond to site issue alerted from Clinical Monitoring Associate (i.e., non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)Collect SRP documents during QV and other visits as neededEstablish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring VisitUpdate all relevant tracking system on an ongoing basisCollaborate with CMA on site issues/actionsGenerate visit/contact report in accordance with monitoring planCode and scan Central File documents where applicableShip relevant wet-ink signature documents to the Assistant or back to the siteEscalate any issues that require immediate action to the Coordinator/GRO LeadInform responsible Coordinator of work status regularlyKeep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentorAttend audits / Regulatory Inspection if requestedMaintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedureComplete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor*Job QualificationsStrong computer and internet skills including knowledge of MS-Office products such as Excel, WordStrong regulatory knowledge including GCPExcellent interpersonal, verbal and written communication skillsSound problem solving skillsAbility to successfully work in a (`virtual) team environmentSound presentation skillsConsultative skillsClient focused approach to work with the ability to interact professionally within a client organizationAbility to prioritize multiple tasks and achieve project timelinesAble to take initiative and work independentlySense of urgency in completing assigned tasksAble to travel a minimum of 65% on averageHolds a driving license where requiredEffective time management in order to meet daily metrics or team objectivesShows commitment to and performs consistently high quality work 职能类别: 临床研究员
联系方式
上海市浦东新区银城中路488号太平金融大厦20层
公司信息
精鼎医药研究开发(上海)有限公司(PAREXEL International),成立于1982年,是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国,分支机构遍布欧、美、亚、大洋四大洲,且于亚洲13个国家和地区设立了分支机构,致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成,服务团队集合各种不同专业领域的人才。我们重视与客户的承诺,更重视人才的培育和养成,我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境,期许同仁与公司一同成长,迈向未来。 愿景(Vision): 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命(Mission): 1.争取国际大药厂委托,执行符合国际水准的跨国性临床试验。 2.协助亚太生技及制药产业建立新药开发模式,以提升产品研发能力,幷促使产品国际化。 3.以提升临床试验品质为宗旨,拓展全球市场为目标,整合计算机及通讯科技,在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4.建立一个以亚洲人种高发生率疾病的基因数据库,以提供国际性新药研发机构所须之基因信息,协助其缩短药物开发时程,幷提高研发成功率。 公司福利和人才培养计划: 保险类: 1. 社会保险(依照国家规定)及住房公积金; 2. 团体保险(包括寿险、意外暨医疗保险); 3. 补充医疗保险; 制度类: 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣,设计符合其个人之生涯规划; 2. 完整的教育训练:每年公司均针对所有员工,提供完整之教育训练; 3. 顺畅的升迁管道及可转调其它部门;如有职缺,亦可申请调至海外各子公司; 请 / 休假制度: 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定; 2. 一年可享12天不扣薪病假; 3. 员工旅游, 年度体检; 精鼎医药将以培养国际性的人才为目标,欢迎具有国际观之人才加入。 应聘方法: 1. 在线投递; 2. 请登录我们的公司网站直接投您的简历(https://jobs.parexel.com/search-jobs) 我们在收到您的简历之后,会尽快与您联系。 谢谢!
上海相关职位
-
GMP验证经理 0.8-2万/月
-
化验分析技术员 4.5-6千/月
-
OTC医药销售代表 0.4-1万/月
-
实验研究员 实习生/Intern 3-4千/月
-
Bio Principal Scientist(PI)生物分析项目负责人 1.5-2万/月
-
实验室助理-Lab Assistant 4.5-5.5千/月
-
生物分析研究员-应届生 6.5-7.5千/月
-
大分子生物分析研究员 8-9千/月
-
省区经理(上海) 3-4.5千/月
-
助理临床监察员 0.8-1万/月
-
医疗器械销售代表 3-4.5千/月
-
维修工程师 6-8千/月
-
医药医务经理/主管(临床/营养/特医/妇幼/医院推广) 15-20万/年
-
医药医务代表(医药/营养/保健/母婴/医院推广) 6-8千/月
-
渠道/OTC销售经理/主管(医药/营养/保健/母婴/快消) 1-1.5万/月