丁香人才 > 职位招聘 >医药研发/制药生产招聘 >上海医药研发/制药生产招聘 >CRA/Senior CRA招聘

CRA/Senior CRA

西安杨森制药有限公司 2016-12-11发布 2017-02-18截止
该职位同时在广东、北京 招聘,欢迎申请。
  • 学历要求: 硕士
  • 外语要求: 不限
  • 年龄要求: 不限
  • 专业要求: 不限
  • 工作年限: 不限
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 上海市
  • 职称要求: 不限
  • 招聘人数: 1人

职位描述

Study Planning/set-up activities
·When required, assist LTM to conduct site feasibility
·conduct Pre-trial visits to assess the investigational staff and facilities
·Discuss the items listed on the PAR with the investigator and other appropriate staff
·Review the site commitment in detail with the investigator
·Develop/adapt recruitment and retention strategy for the site
·Ensure all required trial-related materials and supplies are provided to the investigational site
·Ensure that the investigators send the SUA gap pack to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
·Set up the IF and TCF
·If needed, development of site-specific ICF
·Ensure that the investigational staff are instructed on the requirements for proper informed consent
·When local Ethics Committees are used, ensure that the IEC/IRB is provided with current and complete copies of all documents that the IEC/IRB requests to fulfill its obligation and obtain a copy of the valid written IEC/IRB approval and all related required documents, including the composition of the IEC/IRB
·Obtain site related trial documents and review them for completeness and accuracy
·Negotiate investigator budgets at site level and track the status of site CTA
·Plan and conduct investigator and site-staff training
·Conduct site initiation visits
·If applicable, execute the user acceptance testing plan
·If applicable, create site specific and monitoring tools

Monitoring activities
·Notify the GTM and the Local CSC in writing, when a country and an investigational site is approved to receive clinical drug supplies
·At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (e g , temperature logs, security), and returned, accurately inventoried and documented. Inform the investigational staff of the distribution process
·Conduct monitoring visits according to the checklist of activities listed on the Monitoring Visit Report
·Report to LTM on study site status through monitoring report and meetings
·Document all study related communications
·Perform SDV to ensure accurate data is recorded based if required
·Follow up with the trial site(s) regarding completion of case report forms and data correction forms within required timeframe
·Ensure that all AEs/SAEs/PQCs are reported within reporting timelines and documented as appropriate. For AEs/SAEs ensure they are consistent with all data collected and with the information in the source documents
·Ensure that the investigators send the safety reports to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
·Arrange for the appropriate destruction of clinical drug supplies
·Ensure that the investigational staff stores the randomization codes in a limited access area that is accessible 24 hours a day and instruct them on the code-breaking procedure
·In studies where IVRS/EDC are used, ensure that the IVRS/EDC at the site work smoothly during the study.
·Track costs at site level and ensure payments are made with planned payment schedule
·Ensure TCF is maintained as required and maintain IF
·Ensure subject commitment per site is met
·Conduct site closure visit according to the checklist activities listed on the site closure report
·If applicable, remind the investigator to notify the IEC/IRB of the site closure
·Ensure the IF is complete and accurate
·Provide study report synopsis to investigators, IEC/IRBs
·Check the Site details on Appendix 1 documents and provide feedback to the LTM
·Follow up on and resolve any pending issues, including adverse events and IFDFs one year post-trial

General activities
·Represent the company and the organization adequately to the customers and other external parties
·Base all actions on Credo
·Protect the rights of others, protect privacy and company assets, particularly information as the key asset
·Conduct business in line with the HCC, company policies and procedures, including applicable SOPs, always having the ethical aspect in mind
·Maintain adequate communication with relevant parties within and outside the company
·Comply with ICH-GCP and all applicable local laws and regulations
·Actively follow trainings to ensure adequate qualification for performing job-related tasks
·Report (suspicion of) fraud or scientific/ethical misconduct as appropriate
·Regularly update information in applicable systems and templates
·Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards continuous quality improvement
·Maintain quality standards and timelines that are consistent with business needs

联系人: HR

地    址:北京市朝阳区建国路77号华贸中心写字楼

西安杨森制药有限公司成立于 1985 年,为美国强生公司在华最大的制药子公司。总部在北京,生产基地位于西安,在华员工近 3,000 人。我们一直秉承着对客户负责,对员工负责,对社会负责,对股东负责的信条,致力于引进和生产高质量的创新产品来满足不断增长的医药卫生需求。

美国强生公司创建于1886年,目前在全球60个国家建立了250多家分公司,是目前世界上最具综合性、业务分布范围最广的卫生保健产品的制造商和相关服务提供商,业务领域主要包括制药,医疗器械,和消费品。

西安杨森制药有限公司是美国强生公司在华最大的子公司,成立于1985年。公司管理中心位于北京,生产基地位于西安,在全国28个城市设有办事处,在华员工超过3000人。在过去的25年中,西安杨森保持持续稳定发展,成为了中国领先的合资制药企业。

西安杨森不断引进和生产多种创新的、高品质的药品,涉及九大领域近五十多种包装规格。其产品包括多种高质量的处方药,产品主要涉及胃肠病学、神经学、变态反应学、疼痛管理学、抗菌学、抗肿瘤和生物制剂等领域,西安杨森依托强生公司全球强大的研究开发体系 ...详情

单位概况

西安杨森制药有限公司
近两周应聘简历处理率:20%
制药/生物工程
医药企业 其他
规模不详
北京市朝阳区建国路77号华贸中心写字楼
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