- Career Level Staff
- Offerd Salary ¥4 - ¥6 Million
- Experience Fresh
- Number of employee 1 Person
- Gender Required Both
- INDUSTRY Insurance
- Qualification Associate Degree
- Working Hour 9 to 17:30
- Trial Period 3 months
[Characteristics of position]
1. new facilities develop in cooperation with the public relations department, to help the pioneer-infrastructure of the new implementation medical institution.
2. Proposal consultation / facility selection / clinical trial requester (pharmaceutical manufacturer) consults for a new clinical trial, confirms whether it can be implemented by a medical institution, and provides necessary information to the clinical trial sponsor The
・ If the sponsor requests an interview with the investigator, the schedule will be adjusted and they will be present at the interview.
3. Study implementation decision / protocol agreement The protocol is a study plan that describes the purpose, design, method, statistical considerations and organization of the study. The investigator and the sponsor should document the protocol. I agree.
4. Holding the first IRB (Clinical Trial Review Board), preparing and submitting the materials necessary for deliberation, and supporting the management by attending the IRB
* The clinical trial that led to the agreement of the protocol is the ethical and scientific point of view at the first IRB. Will discuss the appropriateness of the implementation.
5. Conclusion of the contract
After the approval of the clinical trial is approved by IRB, the clinical trial contract is concluded. Supports billing management and billing support for clinical trial costs at medical institutions.
6. Start of clinical trials-End of clinical trials As a contact point for clinical trial sponsors, we support the schedule and management of IRB screening and reporting. In addition, we will take action if SDV or audit occurs.
* SDV: (Source Document Verification / Source Date Verification) Browsing the original material and verifying the content against the original material
* Qualification is not required
Experience in the medical industry
Primary interview + PC skill check (typing, Excel)