study startup and Regulatory specialistAsia Premier One Source, Inc.

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.
Prior project management experience
Strong written and verbal skills
Expert at Microsoft Office, Visio, and Project
RN, MD, or Senior Clinical Research Coordinator Experience
Should be willing to work in graveyard shifts
Company Car
Medical / Health Insurance
Maternity & Paternity Leave
Life Insurance
Entry Level / Junior, Apprentice Health and Medical Business Process Outsourcing 1 opening Bachelor's degree graduate
Founded in 2007, Asia Premier One Source Inc. (APOSI) emerged in the BPO Industry. Known for having highly-trained specialists, exceptional customer services, and innovative yet cost-efficient solutions. We provide Inbound, Outbound, Non-voice and Process Solutions. Our client's success is our focus. With this in mind, the company is centered on the core values of Teamwork, Integrity, Quality, Professionalism, Respect, Innovation, Results Orientation, Entrepreneurial Spirit and Excellent Client Relationship.
Kalibrr

Mandaluyong City, Metro Manila
Permanent
Full-time