北京招聘

主要职责

• To assist study teams in the study conduct with powerful logistic support from CMS in accordance with JunShi written standards and ICH GCP.
• Set up country study file binder and site binders before site initiation according to Junshi and study specific requirements; Be responsible to check the validity of archiving format, category of country/site study files before they are archived to central depot.
• Remind CRAs to retrieve all essential documents from site timely; Check and track all study related documents in a timely manner to make sure document integrality;
• Act as Custodian of Filing Room, track, file and archive all clinical study documents for the ongoing and completed studies in accordance with the related SOPs.
• Clinical trial/research outsourcing services support, including supplier selection, communication, quotation and contract management etc.
• Prepare IEC submission dossier according to the requirements of study managers/CRAs before site initiation and during the study ongoing period; Coordinate CRAs to submit documents within the required timeline and follow the approval letter up. Prepare and provide the standard study index and folds for all the study sites; Copy IEC submission materials and convey them to each IEC.
• Coordinate study documents printing, copying, scanning, fax, mail or email and stamp according to the requirements of project managers/CRAs.
• Study specific facility purchasing (e.g.: fax machine, cabinet, computer etc.); Track each equipment, paper CRFs and other study supplies which provided to sites; Coordinate every shipment of specimen with Courier to make sure the study required condition is met.
• Coordinate PM for logistic arrangement of Investigator Meeting, Project Meeting including meeting budget estimation, suitable travel agency and meeting location selection to fulfill the requirements by study team and company policy; Arrange the meeting logistic things with the help from travel agency (Visa application, flight and hotel arrangement, etc.); Prepare meeting binders and other facilitate tools ; Verify the invoice against original receipt breakdown to ensure fulfilling with the company policy and code of conduct etc.
• Distribute and track SAE report to Investigators in a timely manner according to JunShi SOPs and ICH GCP requirements; Distribute particular letters, such as “Dear Investigator Letter”, newsletter to Investigators/IECs for their notification.
• Assist DM team to maintain the EDC account for Investigators and other ad hoc users.
• As a drug coordinator, provide the necessary coordination in the IMP application and distribution.
• Regularly confirm the drug batch and supply quantity with PM.
• Perform other tasks assigned by line manager and study specific tasks assigned by PM.

基本要求和优先条件

Basic Requirements:

• Bachelor’s degree. Medical major preferred.
• >2 years’ pharmaceutical industry experience with 1-2 years’ strong experience in clinical research.
• Good communication with study team, vendors. Coordination and organization skills.
• Good analytical and problem solving skill
• Prefer to have good command of English in speaking, listening, reading and writing
• Familiar with IT software e.g. Microsoft Word, Excel

Preferred Requirements

• Be familiar with finance.
• Be Familiar with Good Clinical Practice and relevant local regulations.

    上海君实生物医药科技股份有限公司（简称君实生物）成立于2012年，是一家通过源头创新开发*** (First-in-class)或同类最优(Best-in-class)药物而领先于国内创新型生物医药公司。
    君实生物致力于创新药物的发现和开发、及在全球范围内的临床研发及商业化。君实生物拥有蛋白质工程核心平台技术，身处国际大分子药物研发前沿。凭借卓越的创新药物发现能力、先进的生物技术研发、全产业链大规模生产技术和极具市场潜力的在研药品组合，在肿瘤免疫疗法、自身免疫性疾病及代谢疾病治疗方面极富潜力。
    君实生物现有员工430余人，共在全球设有三个创新研发中心，拥有上海和苏州两个生产基地，其中上海临港基地是上海市战略性新兴产业项目。公司拥有15项由在研生物产品和小分子药物组成的产品线，包括9项肿瘤免疫疗法在研产品、3项针对炎症或自身免疫性疾病在研产品、2项代谢疾病在研产品及1项治疗神经性疾病在研产品，适用于多种未满足医疗需求的适应症，有6项已进入临床I、II、III期试验阶段。其中特瑞普利单抗是国内***获批临床研究的PD-1单抗，临床研究结果表明与国际同类产品相比具有卓越的安全性和有效性。
苏州众合生物医药科技有限公司成立于2013年10月，是上海君实生物医药科技股份有限公司的全资子公司。公司主要致力于应用前沿技术进行单克隆抗体生物类似药、创新单抗的产业化，从事产品的生产服务，产品主要覆盖肿瘤、自身免疫性疾病等领域。
公司自2014年7月开始建设GMP厂房，并于2016年5月建设完工，工厂占地面积9610m2，建筑面积约12000m2。
厂区配有两个单抗原液生产车间、两个无菌制剂生产车间以及配套的公用工程、质检、仓储功能区。其中200L及500L生物反应器中试生产车间，能满足客户工艺放大及临床Ⅰ期及Ⅱ期试验产品的需求。2000L商业化生产线，基本使用进口设备并采用国内***的一次性技术，有效的避免交叉污染，无需清洁验证，减少大量运行成本，同时也提高工作效率。制剂采用博世（BOSCH）灌装线和奥普玛蒂（OPTIMA）灌装线，可以满足水针及预填充不同的装量需求，生产线稳定可靠。QC实验室配备大量检测、分析设备，可以满足单抗生产的检定。公司建立了完善的GMP体系管理文件，为公司的良好运作提供了保障。