Study Startup and Regulatory Specialist  

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