太原招聘

职位描述：

职位描述：

岗位职责：
1.全面负责临床研究项目的质量监控和管理工作，如有需要负责重点中心的监查工作，确保试验项目严格按照方案、SOP和相关法规进行；
2.与申办方或上级主管及时沟通，进行中心筛选、主要研究者和参加研究者确定，及时完成项目的总体费用预算，提交上级审批；
3.制定项目总的进度计划表，协助各中心CRA完成各中心的进度计划表，按计划完成试验项目的全面启动、执行与结束工作，并且需要时与项目相关的其他人员进行有效的沟通与协调，如医学写作，数据与统计等；
4.按照制定的试验方案，完成相应的病例报告表、原始病历本和项目管理表格等文件资料，提交上级主管审核；提交组长单位中心伦理资料，取得中心伦理批件；
5.负责试验物资的预算与采购，包括病例报告表、知情同意书等资料的印刷、分配、运输等工作；
6.审阅各中心的临床研究合同，指导CRA与各中心完成研究合同的商谈和签署工作；
7.在项目全面启动前，对项目组成员进行启动前的培训，按计划推进各中心按计划启动；审阅项目组成员的所有报告，与所有相关人员保持有效沟通，在项目进行过程当中进行例行质量控制和进展报告；
8.全面负责本项目组成员（CRA）的带教培训及日常管理工作，协助CRA制定监查计划，同时项目经理本身制定协同监查计划有选择性的进行协同监查，保证试验的进度与质量；
9.与研究者（研究中心）培养并保持良好的合作关系；
10.负责与数据管理部、生物统计部和医学事务部沟通协调，按计划完成数据管理计划书/报告、统计分析计划书/报告、答疑、数据审核会议、总结会议和总结报告等工作；
11.协助上级领导安排的其他工作任务。

岗位要求：

1.具有优秀的团队组织能力和管理技能，如组织召开项目组会议，针对出现的问题能迅速反应并拿出解决方案；

2.临床医学、药学专业本科以上学历（非要求专业，请勿投递简历！）。
3.完全具备3年CRA经验、知识、能力和素质的要求；
4.熟练使用计算机及办公软件。
5.具有独立工作能力，同时又具有强烈的团队合作精神；能够融入团队、奉献团队；
6.具有出色的书面与口头表达能力，善于进行活跃而积极的沟通，与各种不同类型的客户/研究者进行交往，并能建立起良好关系；具备服务意识以及以客户为中心的潜能；
7.具有优秀的团队组织能力和项目管理技能，如组织召开项目组会议，针对出现的问题能迅速反应并拿出解决方案；
8.具有优秀的培训和演讲技能。

Job Description:
1. Take charge of the quality control & management of clinical study projects and the monitoring of major sites, if necessary; ensure the study process in strict accordance with the protocol, related SOP and laws & regulations;
2. Communicate with the sponsor and superior timely, take charge of selecting research sites, determining principle investigator and qualified investigators, and the overall budget-making for a study under necessary review by the superior;
3. Develop the master schedule for study projects, assist CRA in the developing detailed schedules for participating sites, and ensure the initiation, performance and closing of study projects on schedule, communicate with other personnel such as medical writers and data management & statistical analysis staff, if necessary;
4. Collect materials as CRF, original medical records, project management form in compliance with the protocol for the superior’s necessary review, and submit the ethic materials of the head site for the approval letter of Ethics Committee;
5. Take charge of the budget and purchasing of investigational materials and the printing, distribution and transport of CRF & ICF;
6. Review the clinical study contracts of each site and instruct CRA with negotiating & contracting;
7. Train the project team members prior to project initiation, ensure the initiation of each site on schedule, and review all reports from the team members, keep the efficient communication channel with all involved personnel, and take charge of the routine quality control and progress reports during study projects;
8. See to the teaching & training and routine management of team members(CRA), assist CRA with the monitoring plan, and come up with a viable plan by which to perform selective collaborative monitoring of study sites to ensure the trial schedule and trial quality;
9. Set up and cultivate a good cooperation relationship with investigators(study sites);
10. Take charge of the communication of data management dept., statistical analysis dept. and medical affairs dept.; ensure the data management plan/report, statistical analysis plan/report, and Q&A, data review meeting, closing meeting and final report done as planned;
11.Assist in other work required by the superior.

Qualifications:
1. Bachelor degree or above in clinical medicine, pharmacy( Pls don't apply the position without related specialities );
2. Quality as a CRA with 3-year-working experience;
3. Good command of computer and office software;
4. A team player with ability to work independently;
5. Excellent oral & written communication skills, proactive communication capability, good ability to socialize and establish good relationship with all kinds of clients and investigators, and strong sense of service and client focus;
6. Excellent team & project management capability such as organizing the project team meeting; ability to promptly provide solution to an emergency;
7. Outstanding training and presentation skills.

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雅伦生物科技（北京）有限公司由留美技术人员和国内天使投资共同创立，雅伦生物科技注册于中关村丰台园区，洁净厂房位于中关村生物医药基地（大兴），在美国加州及苏州设有分支机构，现有研发人员中具有博士学位的4人，具有硕士学位的5人。公司致力于医疗设备及有源、无源高值血管植入物的研发生产。

雅伦医疗核心团队成员在医疗器械行业的技术研发、质量体系管理、注册申报和市场销售等方面具有几十年的从业经验，公司本着合作和分享的理念，矢志为中国医疗器械产业的发展作出贡献。