The Association of Clinical Research Professionals

CRA Core Competency Foundations™

For organizations seeking to onboard new Clinical Research Associates (CRAs) and establish consistency in foundational knowledge across study teams, ACRP’s CRA Core Competency Foundations™ training program delivers practical, hands-on learning based on real-world protocol execution.

Cost-effective, customizable, and scalable across a broad range of clinical research settings, this program provides an ideal solution for onboarding new CRAs and accelerating their path to competency.

Program Format

This blended learning program combines live instructor-led training with independent learning activities. Participants complete activities between live sessions, allowing classroom time to focus on discussion, problem-solving, and the practical application of core clinical research concepts. The program can be customized to align with organizational goals, priorities, and workforce needs. The training may be delivered virtually or in person.

Prerequisites

Basic foundational knowledge about clinical trials and drug/device development processes, protocol designs, and Good Clinical Practice.

Learning Objectives

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

  • Describe CRA monitoring responsibilities, competency expectations, and the role of monitoring in clinical-trial conduct. 
  • Explain CRA responsibilities for participant protection, recruitment and retention oversight, eligibility verification, informed consent, and safety management. 
  • Verify investigational product management, data review, source-document verification, and essential-record management activities. 
  • Identify protocol, GCP, safety, and investigator-oversight compliance issues and appropriate CRA follow-up actions. 
  • Apply site qualification, site training, relationship-management, and communication practices that support effective monitoring. 
  • Summarize risk-based quality management and monitoring practices aligned with applicable GCP ICH E6(R3) expectations.

Program Features

  • Facilitated by dedicated ACRP subject matter experts
  • Delivered through a combination of independent learning and instructor-led training
  • Designed to engage participants through multiple instructional methods, including text, audio, and hands-on learning activities
  • Cohort-based learning designed to promote collaboration and an engaging learning environment
  • Flexible delivery options including in-person and virtual formats
  • Flexible timelines that help professionals balance training with day-to-day responsibilities
  • Concludes with an assessment to measure achievement of learning outcomes
  • Learners earn ACRP contact hours to support ACRP certification maintenance (if applicable)

Topics Covered

  • CRA Role, Responsibilities, and Monitoring Principles
  • Participant Recruitment and Retention
  • Informed Consent Process
  • Participant Safety Management and Reporting
  • Investigational Product Management
  • Data and Records Management: Submissions, Investigator Reports, and Essential Records
  • Monitoring of Clinical Trial Data: Source Data Review and Verification
  • Protocol Adherence and Noncompliance Management
  • Assessment of Investigator Oversight and Delegated Activities
  • Investigator and Site Qualification
  • Site Training and Relationship Management
  • Quality Management and Risk-Based Monitoring
  • Monitoring Processes: Pulling It All Together
  • Monitoring Medical Device Trials: Unique Considerations