Training for Clinical Research Regulatory Affairs
Required Training for All Research Staff
Please refer to this page for descriptions of clinical research roles. Please refer to this page for required human subjects research training.
Training Resource: Regulatory Onboarding A
Frequency: For new hires: to be completed within 90-120 days of hire. For existing staff, to be completed within 365 days of assignment.
Applies to anyone who is: Designated by his or her department to serve in a Regulatory Specialist A role.
This program requires completion of the following courses: IRB 101, Investigational New Drug/Device (IND/IDE) Sponsor Training, Expanded Access Programs for Drugs and Devices, The Drug Development Process: Improving Trial Feasibility and Exploring your Growth Potential, Introduction to Clinical Trials, Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review, Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA, Key Skills for Ensuing Quality Control through Risk Based Decision Making, Inspection Readiness: Best Practices for Managing Clinical Trial Inspections, Mastering the Event Reporting Cycle: Understanding your impact on Patient Safety, Sponsor Pharmacovigilance (PV) Management, Investigator Responsibilities, FDA Form 1572: Get it Right the First Time, Investigator Initiated Trial Tips and Tricks.
Training Resource: Regulatory Onboarding B
Frequency: For new hires: to be completed within 90-120 days of hire. For existing staff, to be completed within 365 days of assignment.
Applies to anyone who is: Designated by his or her department to serve in a Regulatory Specialist B role.
This program requires completion of Clinical Research Regulatory Specialist A trainings and the following courses: Managing Project Stakeholders, Project Leadership, and Premarketing Clinical Trial Safety.
Training Resource: Regulatory Onboarding C
Frequency: For new hires: to be completed within 90-120 days of hire. For existing staff, to be completed within 365 days of assignment.
Applies to anyone who is: Designated by his or her department to serve in a Regulatory Specialist C or Supervisor role.
This program requires completion of Clinical Research Regulatory Specialist A and B trainings.
This program recommends completion of Leadership Essentials Fundamentals and Regulatory Affairs Certification.
Training Resource: Regulatory Onboarding Associate Director
Frequency: For new hires: to be completed within 90-120 days of hire. For existing staff, to be completed within 365 days of assignment.
Applies to anyone who is: Designated by his or her department to serve in a Regulatory Associate Director role.
This program requires completion of Clinical Research Regulatory Specialist A, B, and C trainings.
This program recommends completion of Leadership Essentials: Advanced. Requiring this program is at the discretion of the supervisor.
Training Resource: Regulatory Onboarding Director
Frequency: For new hires: to be completed within 90-120 days of hire. For existing staff, to be completed within 365 days of assignment.
Applies to anyone who is: Designated by his or her department to serve in a Regulatory Director role.
This program requires completion of Clinical Research Regulatory Specialist A, B, C/Supervisor, and Associate Director trainings.
This program recommends completion of Leadership Essentials Intensive. Requiring this program is at the discretion of the supervisor.
Other Recommended Trainings
FDA 101: An Overview of FDA's Regulatory Review and Research Activities
This course provides a comprehensive overview of the FDA’s regulatory review, research activities, and responsibilities for ensuring product quality and safety. It equips learners with scientific and regulatory knowledge necessary to support the FDA's public health and regulatory goals.
Veeva Vault Clinical - Electronic Trial Master File (eTMF)
This page explains the process of receiving access and training to the Veeva Vault Clinical electronic Trial Master File, a system designed for managing Sponsor and Sponsor team documents.