职位描述
药品临床监查肿瘤药Ⅲ期Ⅰ期Ⅱ期GCP认证
工作职责:
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. 1 to 3 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.)
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. 1 to 3 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.)
职位福利：五险一金、绩效奖金、年底双薪、弹性工作、节日福利、周末双休
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工作地点
上城*********
公司信息
公司介绍
亚太地区全球临床研究组织以科学为驱动力，以卓越为准则 Emerald Clinical Trials是临床研究领域的全球优选合作伙伴，与160余家生物技术公司以及世界前20制药公司中的15家建立了合作伙伴关系。公司总部位于新加坡，融合深厚的科研实力与卓越的运营能力，提供覆盖药物研各试验阶段的端到端临床试验解决方案，包括I至IV期临床试验及真实世界研究。 凭借逾25年的行业经验，以及在全球享有盛誉的肾脏病研究专长，Emerald Clinical依托深厚的科学洞察力、精准无误的执行力以及对质量的坚定承诺，持续推动医学上的重大突破。专业实力与加速发展的交汇点 立足亚太基地，我们整合中国、欧洲中东非洲及美洲的全球团队，携手顶尖研究者与关键意见领袖网络，在肾脏病、肿瘤学、心血管代谢疾病及早期研究领域推动更快速、更智能的研发进程。不仅仅是CRO——真正的科学合作伙伴 我们不仅执行研究，更引领研究。Emerald Clinical Trials将复杂研究转化为切实成果，推动创新发展，助力为全球患者提供改变生命的疗法。
工商信息
企业名称 上海世和弘翼医学临床研究有限公司
企业类型 有限责任公司(外商投资企业法人独资)
法人代表 么卉园
经营状态 在营（开业）
成立时间 2011-09-23
注册资本 9632.3529万元
认证资质
营业执照信息
