Study Startup and Regulatory Specialist
Six Solutions Inc.
- Mandaluyong, PhilippinesSheridan St, Buayang Bato, Mandaluyong, Metro Manila, PhilippinesMandaluyongMetro ManilaPhilippinesPhilippines
- 33.000,00 PHP - 35.000,00 PHP / monthPHP330003500033000MONTH
- Toàn thời gianFULL_TIME
Miêu Tả Về Công Việc
Role and Responsibilities
The candidate in the role will be responsible for the following key tasks:
1. Ability to track startup of newly awarded studies
2. Ability to complete all required paperwork for study startup including regulatory paperwork
3. Ability to submit IRB paperwork
4. Work with recruitment team and contract team to create compensation language for each upcoming study
5. Ability to build e-source study templates (training will be provided)
6. Maintain and update CVs, training certificates
7. Interact with vendors to ensure all needed study startup forms are completed and submitted to CRO/Sponsor contacts
8. Design study process flows and staff workstations
9. Conduct and maintain production meetings for new studies
10. Interact with marketing and ensure all marketing materials for studies are built and implemented
11. Ensure study staff have completed all required trainings, fully comprehended protocols, and have all required system access
12. Schedule and coordinate staff travel for Investigator Meetings
13. Schedule and coordinate Pre-Site Selection Visits, Site Initiation Visits
14. Other miscellaneous tasks assigned by the Company
15. Create pre-screening questionnaire and ensure it is entered within CRIO in a timely manner
16. Ensure you have reviewed and are knowledgeable on all active and upcoming protocols
17. QC daily visits and create queries within the CRIO system
18. Send weekly unresolved query report to site manager
19. Ability to track and maintain monitor visits
20. Review all sponsor follow up letters with the study’s Lead CRC and ensure all action items are resolved prior to the next monitoring visit.
Trình độ tối thiểu
-
Prior project management experience
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Strong written and verbal skills
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Expert at Microsoft Office, Visio, and Project
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RN, MD, or Senior Clinical Research Coordinator Experience
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Should be willing to work in graveyard shifts
Đặc quyền và lợi ích
- Company Car
- Medical / Health Insurance
- Maternity & Paternity Leave
- Life Insurance
Tóm tắt công việc
- Trình Độ Công Việc
- Mới Tốt Nghiệp/ Trình Độ Tập Sự
- Ngành Nghề
- Health and Medical
- Yêu cầu học vấn
- Tốt nghiệp Cử nhân
- Nhà tuyển dụng trả lời hồ sơ
- Sometimes
- Địa chỉ văn phòng
- Rockwell Business Center Sheridan, Sheridan St, 1554 Mandaluyong, Philippines
- Ngành nghề
- Employer on Records & Staffing
- Vị trí đang tuyển
- 1 vị trí tuyển dụng mới
- Trang web
- https://www.asiapremierbpo.com