The Association of Clinical Research Professionals

ACRP CRA Core Competency Foundations™ Training Program

For employers who need to onboard new CRAs and/or establish consistency in foundational knowledge to keep study teams working in lockstep, ACRP’s CRA Core Competency Foundations™ training program delivers practical, hands-on learning based on real-world protocol execution.

ACRP’s CRA Core Competency Foundations™ program is an ideal solution for onboarding new CRAs, accelerating time to productivity, and helping standardize CRA training organization-wide.

Learning Objectives

Upon completion of this course, participants should be able to:

  • Develop an understanding of Good Clinical Practices (GCP) and the expectations of CRA competency
  • Introduce essential duties that CRAs may perform to ensure that the sponsor’s responsibilities under ICH GCP are fulfilled
  • Introduce and review different competency areas that CRA should be familiar with to perform their trial related duties

Specs & Features

  • Facilitated by Dedicated ACRP Instructors Who Are Subject Matter Experts
  • Delivered Through Combination of Independent Learning and Facilitated Instructor-Led Training
  • Designed to Meet Various Learner Styles Through Use of Text, Audio, and Learning by Doing
  • Community-Based Learning in Cohorts to Foster a Positive, Active-Learning Environment
  • Flexible Delivery Options Including In-Person, Virtual, or Teach-to-Train
  • Flexible Timelines to Help You Balance Training Commitment with Day-to-Day Priorities*
  • Concludes with Assessment to Validate Knowledge Gain and Justify ROI
  • Learners Earn ACRP Contact Hours to Support ACRP Certification Maintenance (if applicable)**

* This program is typically 40 hours and delivered over multiple days.
**The number of Contact Hours will be determined by the final course length.

Agenda

  • Course Overview, Competency Development, and Monitoring Competencies
  • Subject Management Competencies: Subject Recruitment and Retention
  • Subject Management Competencies: Informed Consent
  • Subject Management Competencies: Safety Management
  • Investigational Product (IP) Management
  • Data and Document Management: Submissions, Investigator Reports, and Essential Document Management File
  • Data and Document Management: CRF / Source Document Verification
  • Protocol/GCP Compliance Management
  • Evaluate and Ensure Adequate Principal Investigator (PI) Oversight
  • Site / Site Relationship Management: Site Qualifications
  • Site / Site Relationship Management: Site Supplies and Training
  • Quality Management Approaches and Monitoring Practices
  • Monitoring Approach/Process: Pulling It All Together
  • Monitoring Medical Device Trials: Unique Considerations
  • Wrap-Up and Reflections