The Association of Clinical Research Professionals

ACRP CRC 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

  • Overview and Roadmap
  • Clinical Research 101 Orientation
  • Clinical Research Relationships, Responsibilities, Documents, and Processes:
    • PI Responsibilities
    • Essential Documents
    • IRB/IEC Reports
  • Good Clinical Practice and Human Subject Protection Check-In: Your Questions Answered
  • Everything You Need to Know About ALCOA-C
  • Patient Recruitment and Retention 101
  • Subject Safety Management Check-In
  • IP Management and Accountability 101
  • Protocol/GCP Compliance and Monitoring Overview, and CAPAs and Root Cause Analysis (RCA) 101
  • Optimizing Study Communications: Best Practices
  • Study Feasibility and Site Selection
  • Pulling It All Together: A Day In the Life of a CRC
  • Core Competency Training Reflections and Wrap-Up