北京招聘

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.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！）。
2.完全具备3年CRA经验、知识、能力和素质的要求；
3.熟练使用计算机及办公软件。
4.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；
5.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；
6.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；
7.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. 举报 分享

Company Overview

GCP ClinPlus Co., Ltd. (hereinafter referred to as GCP) is a combination of three well established companies: Beijing DMS Pharma Ltd., with CRO as its primary business; YiXie ZhongTai MedTech Consulting Ltd, committed to provide medical device product registration and relevant consultation; SMO unit, mainly engaged in Site Management Organization (SMO). All three companies are so mature and distinctive that they can take advantage of each other’s strengths.
GCP provides clinical research solutions which are customized and comprehensive, of international standards and making full use of various network and resources. The services of GCP, with the untiring effort of innovation and extending to new field, cover the evaluation and counseling of new drug R&D, regulatory affairs, clinical trial monitoring and management, data management, statistical analysis, medical affair and training, involving fields of pharmaceutical, biological product and medical device.
GCP is of a well trained professional team. All the operation team members have various professional backgrounds of clinical medicine, pharmacy or nursing etc. The management team is composed of group of senior people with deep knowledge of clinical medicine, pharmacy or biometrics and with rich experience of management. All of them have had over 10 years experience in various management positions in multinational pharmaceutical companies as well as famous CRO companies.
In early 2011, GCP signed the JV agreement with CMIC Co., Ltd. to enhance the capability and widen the geographic coverage. The win-win cooperation would surely enhance the core competitiveness and open a new chapter of accelerating development of GCP.


公司概况

普瑞盛（北京）医药科技开发有限公司由三家发展成熟，各具特色，优势互补的公司合并组成：以CRO业务为主体的北京迪美斯科技发展有限公司；提供全程医疗器械产品注册及咨询服务的医协众泰；以Site Management Organization (SMO) 业务为主体的博尔泰科。
普瑞盛致力于提供全方位的、符合国际标准的、充分利用人脉和地域资源的个性化临床研究解决方案。在坚持创新和拓展新领域的不懈努力下，普瑞盛的服务涵盖新药研发评估与咨询，注册事务，临床试验实施，数据管理和统计分析，医学事务及培训；业务范围涉及制药、生物技术和医疗器械等。
普瑞盛拥有一支富有拼搏精神的专业队伍，临床运营团队均具有临床医学、药学、护理学等背景；管理团队是由一批具有丰富临床医学、药学、生物统计学及管理学等经验丰富的资深人士组成，且皆拥有逾十年的跨国制药企业及著名CRO从业经历。
2011年初，普瑞盛（北京）医药科技开发有限公司引入外资，与日本希米科株式会社正式签定合资协议，成为中外合资企业。强手联合，增强了核心竞争力，揭开了快速发展的新篇章。

                                  律师声明

    近期，普瑞盛（北京）医药科技开发有限公司（以下简称“普瑞盛公司”）发现有不法分子冒用普瑞盛公司的名义，私刻人力资源部门的公函印鉴，公开发布虚假招聘、录用员工信息，给普瑞盛公司正常的人事管理工作带来了极大损害。
    北京市冠平律师事务所（以下简称“本所”）为普瑞盛（北京）医药科技开发有限公司（以下简称“普瑞盛公司”）常年法律服务支持机构，现根据普瑞盛公司的授权委托，由本所律师发表严正声明如下：
  1、任何以普瑞盛公司人事部印鉴形成的合同、入职邀请函等均为假冒侵权文件，凡持有上述文件的单位和个人，在本声明发布后，可与普瑞盛公司人力资源部门联系（电话:010-56088208），以确认相关事宜。
  2、普瑞盛公司已就上述侵权事件向属地公安机关报案，希望有关当事人立即停止侵权行为，消除不良影响。同时，郑重提醒愿望入职普瑞盛公司的个人，请直接与人力资源部门联系。
    3、本所律师已启动密切关注侵权者一切侵权行为的诉前程序，并将严格按照普瑞盛公司对事态发展的要求，保留进一步追究侵权者法律责任的权利。
  4、对任何与伪造普瑞盛公司人事部印鉴的持有者签订合同及进行业务往来的个人和单位，普瑞盛公司将不承担任何责任。受害个人和单位应直接到公安机关报案。

  特此声明！
                                                                         北京市冠平律师事务所穆华敏律师

                                                                                          2013年9月29日