The Site Owner Academy

This 5 week, fast-paced course is designed to take a research naive clinician through the entire process of running their own research clinic, or being an Investigator at another clinic. The first course starts the week of November 4, 2024. The cost of the course is $5,000 USD.

Week 1: General Responsibilities of Principal Investigators

  • GCP

  • FDA

  • Protocol

  • SOP

  • IRB

  • PI Oversight

  • Source documentation

  • Adverse Event reporting

  • Regulatory

Week 2: Research Staff, Training, and Office Layout

  • PI

  • Sub I

  • Research Coordinators

  • Site Monitors

  • Patient Recruiters

  • Staff workload

  • Contracts and Budgets

  • Clinic set ups

  • Equipment

Week 3: SOPs, Regulatory & Source

  • What are SOP

  • What are regulatory documents

  • What are source documents

  • Inclusion/exclusion criteria

Week 4: Monitoring Visits and Quality Assurance

  • Site selection

  • Site initiation

  • Interim monitoring

  • Close out

  • Audits

  • Quality control/assurance

Week 5: Contracts and Budgets/Patient Recruitment

  • What is included in a contract

  • How to negotiate a budget

  • Fair market value

  • Pre screening

  • Database mining

  • Retention

Meet the Team

  • Dan Sfera

  • Chris Sauber

  • Monica Cuitiva

  • Ashley Margo

  • Judy Galindo

  • Dashan Kulkarni

Have one of our staff reach out!