上海招聘

? Pre-Study/Start up Site Management Activities
-- Identify potential sites, investigators and site staff;
-- Establish site-level recruitment strategy/plan
-- Ensure required documents, e.g. subject informed consent(s) and protocol, are approved by the applicable local Ethics Committee(s)
-- Ensure all required study start-up documentation and supplies (drug and non-drug) is in place and the site is able to start on time and according to plan
-- Establish investigator file and submit essential documents to trial master file
-- Ensure adequate contract is signed and payment is defrayed according to contract
-- Ensure timely site initiation in line with project timeline
-- Build and maintain positive relationships with the site and investigators
-- Create site information in CTMS and project tracking tools on site level
-- Complete timely reports/correspondence to record issue, action plan and resolution

? Study conduct site monitoring activities.
-- Complete site recruitment according to recruitment strategy/plan
-- Carries out monitoring activities, on-site visits or remote communication, in line with monitoring plan, ensuring adherence to protocol and study procedure, ICH - GCP guidelines and local regulations.
-- Perform SDV during on-site monitoring visits according to the protocol SDV plan
-- Perform site-level drug accountability (ensuring proper handling, storage, administration, record-keeping and disposition) and emergency codes check
-- Verify storage and shipment of biological samples and other protocol specific diagnostics requirement
-- Maintain and update investigator file, submit essential documents to trial master file
-- Verify timely, complete and accurate reporting of SAE/Pregnancy Forms. Ensure site receives all safety information and submits these reports, as appropriate, to the local ethics committee/Health Authorities
-- Submit update study information (e.g. protocol, subject informed consent form, regular study progress report) to the applicable local Ethics Committee(s) and get approval within time frame
-- Update site information in CTMS and project tracking tools on site level
-- Complete timely reports/correspondence to record issue, action plan and resolution
-- Ensure timely and accurate payment to site according to contract and progress

?Conducts Study Site Close-Out Activities.
-- Ensure proper return and disposition of all study-related supplies and equipment
-- Notify site and EC of the completion of the study and submit study reports as requested
-- Ensure site information in CTMS and project tracking tools is complete
-- Ensure site reports and correspondence is complete
--Complete audit finding solution, if the study is registration study, CRA need to do the CFDI inspection readiness preparation and handle the site inspection activities.

? Project Management Activities (As the senior CRA)
--Partial working time could be spent on small-scale clinical trials management activities refer to CPM’s Job Responsibilities as requested under line manager’s support, as a part of achieving personal development in the CRA position.
--In one study, support PM to do the part working of project management as the lead CRA.


任职要求：
? Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse , BPharm)
? At least 1-2 years clinical operation monitor experience for senior position.
? Good knowledge in GCP for senior position
? Good command of written and verbal English
? Good communication and organization skills
? Good and proactive working attitude
? Value importance of teamwork
? Ability to work independently
? Experience in oncology study is preferred
? Travel needed

    江苏晨泰医药科技有限公司成立与2017年1月，是一家专注于研发创新疗法以满足医疗急需的临床研究阶段的公司。公司的管理团队在肿瘤治疗、临床运营、注册事务、医药营销等医学研究方面有几十年经验。目前在上海、北京设有办事处。
    2018年6月19日，晨泰医药科技有限公司（“晨泰医药”）宣布其成功完成A轮6,500万美元融资的首次交割，共计3,700万美元。这次融资由国内知名风险投资机构启明创投领投。其他几家知名的投资公司也参与了这一轮融资，其中包括泰福资本和醴泽健康产业投资基金。A轮募资将用于开展公司主要在研产品AZD3759的国际多中心II期临床试验，和进一步丰富公司的产品管线。
   为致力于全球化创新药物的临床开发。公司与国际大型制药公司合作, 确保产品的前期研发工作扎实可靠。利用公司强大的科学顾问和管理团队，制定最优化的创新药物开发策略，注重研发/市场/知识产权保护的多维布局。具体试验操作和业务开展方面与国际/国内顶尖的CRO/CMO/医院/研究院所合作，使用公司完善的项目管理体系来协调、监督项目合理有序开展。