Study Startup & Regulatory Specialist  

• 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.

Study Coordination

• Conduct study visits over the phone for COVID-19 studies
• Consenting subjects
• Registering subjects within the IWRS system
• Entering data within our EMR system and the sponsors EDC portal
• Uploading any test results that have been analyzed by study vendors
• Reviewing and auditing peers study visits

• Candidates should have at least 2 years related work experience in Clinical Research or as a Study Coordinator
  • College Graduate of Bachelor’s Degree in Pharmacy, Biology, or other related medical degree
  • Comprehensive knowledge of FDA, GCP, HIPAA, Confidentiality agreements, and policies
  • Familiar with EMR tools (Medidate and Rave)
  • Good Clinical Practice Certification is a huge plus!
  • Experienced with project management
  • Willing to work on a shifting schedule, night shift, weekends, and holidays
  • Willing to work onsite