Study Start Up and Regulatory Specialist  

Role and Responsibilities

The candidate in the role will be responsible for the following key tasks:

• Ability to track startup of newly awarded studies
• Ability to complete all required paperwork for study startup including regulatory paperwork
• Ability to submit IRB paperwork
• Work with recruitment team and contract team to create compensation language for each upcoming study
• Ability to build e-source study templates (training will be provided)
• Maintain and update CVs, training certificates
• Interact with vendors to ensure all needed study startup forms are completed and submitted to CRO/Sponsor contacts
• Design study process flows and staff workstations
• Conduct and maintain production meetings for new studies
• Interact with marketing and ensure all marketing materials for studies are built and implemented
• Ensure study staff have completed all required trainings, fully comprehended protocols, and have all required system access
• Schedule and coordinate staff travel for Investigator Meetings
• Schedule and coordinate Pre-Site Selection Visits, Site Initiation Visits
• Other miscellaneous tasks assigned by the Company
• Create pre-screening questionnaire and ensure it is entered within CRIO in a timely manner
• Ensure you have reviewed and are knowledgeable on all active and upcoming protocols
• QC daily visits and create queries within the CRIO system
• Send weekly unresolved query report to site manager
• Ability to track and maintain monitor visits
• 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
• Proficient with Microsoft Office
• Must be a graduate of any medical field, preferably, a Registered Nurse, Medical Technology, or Pharmacy
• Willing to work on night shift, and holidays
• Willing to work at Mandaluyong City