南京招聘

Overall Job Purpose/Function:

To perform clinical monitoring activities of designated projects and ensure sites conduct clinical procedure in accordance with the WuXiapptec. SOPs (or the Sponsor’s SOPs as appropriate) ,and the ICH GCP guidelines.

Pricipal Accountabilities and Responsibilities:

- conducts pre-study site management activities and initiate the site activities

？ Contributes to the site and investigator selection process for their area of responsibility by making appropriate recommendations

？ Ensures subject informed consent(s) and protocol are approved by the applicable local Ethics Committee(s) and informed consent processes at site are in place

？ Assists and provides feedback on sites issues during site contract development and negotiation process

？ Ensures all required study start-up documentation is in place and the site is able to start on time and according to plan

？ Performs required site training in a range of areas to ensure investigators and site staffs are prepared to conduct the protocol according GCP, local regulations, and Wuxiapptec criteria and processes

- Performs on site and off site monitoring activities during study conduct to ensure compliance with protocol , GCP guideline and WuXiapptec SOP.

？ Conducts on-site visits and monitoring activities in line with the monitoring plan

？ Evaluates and follows site patients recruitment at least monthly on basis of project recruitment plan during enrollment phase and ensures recruitment issues and needs adequate

？ Perform SDV during on-site monitoring visits according to the protocol SDV plan

？ Verifies complete and accurate reporting of SAE/Pregnancy Forms

？ Performs site-level drug accountability and reconciliation activities to ensure proper handling, storage, administration, record-keeping and disposition of study drug(s) per GCP, local regulations, and protocol

？ Verifies storage and shipment of biological samples and other protocol specific diagnostics requirements

？ Assesses ongoing training needs of all site personnel and takes appropriate actions to ensure necessary training is performed in a timely manner

？ Verifies and collect study data to office according to CRF collection plan and resolve discrepancies according to agreed upon timelines

？ Performs off–site monitoring activities between site visits, after site visits and according to monitoring plan

？ Writes and submits timely reports/correspondence to document site management activities and findings as per monitoring plan

？ Submit essential documents to archive, reconcile documents sent/received to archives, assess study progress, review electronic data and raise/close monitor discrepancies, as appropriate, assess staff/facility changes, assess need for more study supplies, follow-up monitoring visit action items,

？ Attends site audit and executes site audit action plan

- Conducts Study Site Close-Out Activities

？ Performs final site-level drug accountability and reconciliation and ensures

？ return/destruction on local level

？ Ensures proper return and disposition of all study-related supplies and equipment

？ Performs and verifies final reconciliation of essential documents between investigator files at site and WuXiapptec archives

？ Check all receipts have been collected from site timely.

？ Ensures investigator understands requirements for archiving the investigator files and has the capability to archive for the designated period of time

Requirements for position:

- Possessing a clinical medicine/pharmacology or other bio-medical related scientific degree, which can vary from a bachelor, master and nursing qualification;

- 0-3 years of working experience as CRA;

- Working knowledge of clinical research procedures and practices including local regulatory requirements and GCP/ICH Guidelines for the conduct of clinical studies;

- Open and clear communicator;

- Confident , highly self-motivated and work independently;

- Coordination and planning of budgets, people and time management;

 十一年前，药明康德的创始人李革博士肩负着“变革新药研发、造福人类健康”的人生理想，创立了药明康德；如今，药明康德已成为在中美两国拥有5600余名员工、中国首屈一指、全球领先的医药研发外包服务供应商，在全球九大城市拥有运营实体，客户囊括全球制药巨头前二十。作为国内医药研发服务的领头羊，药明康德无疑是卓越的医药研发平台，并继续致力于打造创新型的、全方位一体化的研发服务平台。
    药明康德绝不停留于自身的卓越。药明康德的血液里一直流淌着“爱才惜才”的文化，让每一位员工“从优秀到卓越”，给每一位员工一个“精彩的人生理想舞台”，更是公司一直所追寻的企业文化和宗旨。药明康德将引领你进入世界级医药研发的殿堂，在你实现人生理想的征途上，激励护航。
    我们的人才—既有曾服务于辉瑞、礼来、默克等世界制药巨头的科学家，也有大批从校园毕业后直接进入药明康德工作并脱颖而出的优秀人才。
    我们的客户—集中于欧美国家的国际知名制药、生物制药和医疗器械公司。
    我们的设备--世界一流水平的研发生产设备设施是我们高效率、高质量、高标准的基本要求，也是确保我们的员工掌握世界最前沿技术的第一保证。
    海阔凭鱼跃，天高任鸟飞，你的才华在药明康德可以展现；你的梦想在药明康德可以实现，我们将为你铺就走向闪耀人生的成长之路！这里，是卓越的药物研发平台，更是精彩的人生理想舞台。
 
    药明康德将为您提供：
    更全面的薪酬福利体系----工作生活的最佳平衡
    更加丰富的文化升华----拉近你我心的距离
    更完善的培训机制----不断提高综合素质，帮助我们全面成长
    更多职业发展空间----竞争和挑战我们积极面对
    
    怀揣梦想，带上热情，加入药明康德，未来的篇章由你尽情书写。
 
 
近期荣誉和奖励
2011年药明康德入选"2011年中国服务外包十大领军企业"
2011年药明康德董事长兼首席执行官李革博士荣膺"2011中国服务外包杰出贡献人物”
2010年药明康德苏州毒理中心获得由国家食品药品监督管理局（SFDA）颁发的优良实验室管理规范（药物非临床研究管理规范）（GLP）证书
2010年药明康德苏州毒理学中心获得经济合作与发展组织GLP认证
2010年药明康德上海合全药业荣获由SGS颁发的ISO14001证书
2010年药明康德苏州毒理中心荣获国际实验动物评估认证管理委员会 (AAALAC) 的国际认证
2004，2005，2006，2007，2008以及2009年连续六年荣膺“德勤亚太地区高科技高成长500强”
2005，2006，2007，2008以及2009年连续五年荣膺“德勤中国高科技高成长50强”
2009年荣获“第七届中国大学生医药行业十佳最佳雇主”
2009年荣获“中国十大服务外包领军企业”
2009年荣列《快速杂志》“世界最具创新力企业年度50强”