石药集团招聘

1. 负责调研、选择、提供试验中心和研究者相关信息，根据试验进度及时提供试验相关信息；
2. 协助在项目计划时限内获得各项临床试验文件及伦理委员会批件，并对伦理委员会批件进行初步审核；
3. 组织筹备和参加研究者会议并在会上作相应的会议记录，负责本中心研究者的联络与接待工作；
4. 对所负责的研究中心进行全面管理，严格按照GCP、SOP、试验方案和中国法律、法规，并在项目计划时限内按时完成研究中心的选择、启动、常规监查和中心关闭。

任职资格
1.统招本科及以上学历，临床医学、药学、护理学、生物学等相关专业，最起码1年以上CRA或2年CRC工作经验；
2.英语CET-4及以上，熟练应用Office办公软件、良好的PPT制作能力及培训演讲能力；
3.有肿瘤项目经验者优先考虑
4.具有较强的沟通能力、组织管理能力和协调能力。

1、根据试验方案进行中心筛选、项目启动、患者入组、常规监查、中心关闭等工作；

2、根据临床试验标准确保临床数据相关文档的准确性、时效性、完整性等；

3、熟悉临床试验操作流程，及时反馈并汇报临床试验进展；

4、保持与研究单位和相关专家的良好沟通和协调，发现并及时地协调解决临床试验过程中出现的问题。

任职要求：

1、统招本科及以上学历，临床医学、药理学、临床药学等相关专业；

2、3年以上CRA经验；

3、熟悉临床试验质量管理规范（GCP）和临床工作相关法规；

4、具有良好的协调组织及沟通能力，勤奋进取，细致耐心，具有团队合作精神，适应出差工作；

5、优秀的任务管理和时间管理能力。

6、具有较强的执行力；

7、自我驱动力强，结果导向；

8、具有良好的英文水平。

恒瑞医药-上海盛迪医药有限公司

1. The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and
reported in accordance with the protocol, standard operating procedures (SOPs), ICH‐GCP, and all applicable, Regulatory requirements.

2. Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines

3. Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites

4. Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely

5. Provides regular site status information to team members, trial management, and updates trial management tools

6. Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations

7. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues

8. Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed

9. Performs essential document site file reconciliation

10. Performs source document verification and query resolution

11. Assesses IP accountability, dispensation, and compliance at the investigative sites

12. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines

13. Communicates with investigative sites

14. Updates applicable tracking systems

15. Ensures all required training is completed and documented

16. Be assigned logistical support tasks by CTM for Investigator Meetings
任职资格:

1. 2 to 4 years of local trial experience; exposure to MNC and global or Local Phase I -IV trials Clinical research experience

2. Knowledge of ICH and local regulatory authority regulations regarding drug

3. An advanced degree (e.g., M.S., M.B.A., Phar.D., etc.)

上海康德弘翼医学临床研究有限公司

1.负责根据法规及GCP、SOP、试验方案、监查计划的要求进行临床试验项目监查工作(中心筛选、试验准备与启动、实施、收尾等工作)；确保临床试验按照GCP等法规、试验方案要求实施，确保临床试验过程、数据的完整、真实和规范；

2.按照项目工作计划，参与或负责与研究中心、申办方、SMO、检测单位等合作单位及相关人员进行项目的沟通、协调及处理相关工作事宜和解决问题，保证项目按计划进展；

3.定期、如实汇报项目监查工作报告，收集试验记录文件资料；及时处理各类突发事件；

4.负责维护临床研究中心研究者、机构\伦理的良好关系；

5.协助完成项目团队中的其他工作；

6.完成上级领导安排的其它任务。

任职要求：

1.2年及以上临床监查经验，有独立全流程监查经验和技术能力；

2.具备基本的项目管理知识，并履行好项目分工职责，能够带领1-2名初级CRA完成项目；

3.善于学习，责任心强，善于沟通协调，抗压能力强；
4.能够适应高强度外派出差。

重庆恒誉康医药科技有限公司

1. 确保临床试验全过程符合方案、SOP、GCP和相关法规的要求；


2. 负责试验中心的选择，确保试验中心是具备临床试验资质的，并符合试验方案、公司的要求；


3. 负责试验中心的启动监查、常规监查、关闭中心监查，并按时提交监查报告, 确保试验数据的质量；


4. 确保试验中心药物的储存、发放、回收，并根据试验方案、SOP、ICH-GCP/中国GCP和相关法规报告有关的背离；


5. 确保试验中心按照方案和法规的时限及时报告AEs；


6. 确保与研究中心的研究人员保持良好的专业合作关系；


7. 协助项目经理进行部分相关管理的工作；


8. 参与合作方的管理。


任职要求:


1. 3年以上CRA经验；


2. 有外资或大型CRO工作经验优先；


3. 有肿瘤项目监查经验优先；


4. 有自身免疫疾病监查经验优先；


5. 具备优秀的专业知识和技能；熟悉临床试验的全过程；


6. 具有很强的团队管理能力、沟通能力、创新能力、应急管理能力及独立分析解决问题能力

神州细胞工程有限公司

及工作内容：

1.根据法规及GCP、SOP、试验方案、监查计划的要求进行临床试验项目监查工作(中心筛选、试验准备与启动、实施、收尾等工作)；确保临床试验按照GCP等法规、试验方案要求实施，确保临床试验过程、数据的完整、真实和规范；

2.按照项目工作计划，参与与研究中心、申办方、SMO、检测单位等合作单位及相关人员进行项目的沟通、协调及处理相关工作事宜和解决问题，保证项目按计划进展；

3.定期、如实汇报项目监查工作报告，收集试验记录文件资料；及时处理各类突发事件；

4.协助完成项目团队中的其他工作；

5.完成上级领导安排的其它任务。

任职要求：

1.临床医学、药学、公共卫生、护理等相关专业，本科及以上学历；

2.接受优秀应届生及转行人员；

3.善于学习，责任心强，善于沟通协调，抗压能力强；

4.掌握岗位基本法律法规，掌握基本的临床研究相关知识；

重庆恒誉康医药科技有限公司

Summarized Purpose:
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.


Key responsibilities
· Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to prove that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
· Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
· Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
· Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
· Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
· Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
· Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.
Keys to Success


Education and Experience:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Knowledge, Skills and Abilities:
· Basic medical/therapeutic area knowledge and understanding of medical terminology
· Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents.
· Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
· Good interpersonal skills.
· Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
· Good organizational and time management skills.
· Ability to remain flexible and adaptable in a wide range of scenarios.
· Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
· Ability to manage Risk Based Monitoring concepts and processes.
· Ability to work in a team or independently as required.
· Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
· Good English language and grammar skills.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

赛默飞世尔