台灣樂天醫藥生技股份有限公司
English Required
In-house CRA
10/14 Updated
Full-time
Mid to Senior Level
English Required
Partially Remote
Salary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
台北市中正區
Required
Language Requirements
English
聽/中等、說/中等、讀/中等、寫/中等
Work Experience
1年以上
Job Description
Key Duties and Responsibilities
• Manage clinical studies by planning and assisting in study start-up activities such as the creation of Monitoring Plan, Laboratory Manual, Pharmacy Manual, Site Initiation Presentations, CRF Completion Guidelines and various forms and study tracking and management documents.
• Assist with oversight and management of CRO, including project tracking of subject and site information.
• Assist with the development of site tools and clinical trial start up activities.
• Establish and maintain the documents within electronic and/or paper Trial Master File with minimal supervision.
• Receive and review all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required.
• Review site study documents (e.g., informed consent template and study tools/worksheets).
• Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations.
• Assist clinical operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF.
• Handle incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and vendors, as needed.
• Provide assistance in confirming and verifying vendor or site contracts, as well as reviewing associated invoice expenditures for accuracy and compliance.
• Assist with all aspects of initial study drug/device shipment release including regulatory packet review and study-drug release.
• Assist clinical study team with the planning, preparation, and on-site support of investigators’ meetings.
• Perform or oversee CRO pre-site selection and site initiation, as well as interim, close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements, to assure good site performance, and evaluate CRO CRA performance.
• Communicate directly with sites, Contract Research Organizations (CROs) and CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities.
• Review and manage monitoring report review and follow-up within project-specific timelines.
• Assist with tracking of clinical trial progress including status update reports, as requested.
• Comply with company regulatory, safety and compliance procedures and practices.
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
生物學相關、護理助產相關
Work Schedule
日班
Leave Policy
週休二日
Job Skills
New Drug Research and Experiment Planning and Execution
新藥研發實驗規劃執行
Job Category
Pharmaceutical Research and Development Staff
台北市中正區
其他專業／科學及技術業
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.
