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CLINICAL RESEARCH TRAINING

CLINICAL RESEARCH ASSOCIATES: THE LEAD CLINICAL RESEARCH ASSOCIATE (TEAM LEAD)

COURSE DESCRIPTION:

This one day course prepares you to successfully lead your team through effective communication, use of best practices, critical and risk-based thinking, all while focusing on compliance. The course topics focus on strengthening and refining your people and communication skills, while developing strategies for successful team performance and management of the project.

LEARNING OBJECTIVES:

  • Demonstrate effective communication skills

  • Examine best practices for effective leading of projects/CRA teams by exploring ways to enhance time management and communication skills

  • Understand the concept of and how to implement risk-based thinking throughout monitoring of a clinical study

  • Identify methods to improve site compliance through implementation of CAPAs

COURSE OUTLINE

AGENDA: 8:30 am - 4:30 pm

  • Lead Clinical Research Associate Role and Responsibilities

  • Being an Effective Lead CRA

    • Fostering Excellent Report Writers and Ensuring Timelines Are Met

    • Protocol Deviations: Identifying, Documenting, Managing and Reporting

    • Leading Teams: Managing Different Personalities and Having Challenging Conversations

    • Time Management: Strategies for Leads and the CRAs on their Team

  • Corrective and Preventative Action Plans: Identifying, Documenting, and Implementing to Improve Site Compliance

  • Risk-Based Thinking

    • Risk-Based Monitoring Throughout a Study: Best Practices & Methods

    • Monitoring with an Auditing Perspective

ADDITIONAL WEB-BASED COURSE ADD-ONS

  • GCP & US FDA Regulations Refresher

  • Critical Thinking in Clinical Research

  • FAIR ShakeTM

  • Dealing with Difficult Sites

Training Solutions For These Roles

  • Lead CRAs, Team Leaders, Project Managers, Clinical Project Coordinators, and/or those responsible for managing a project with a team of CRAs

  • Experienced CRAs who are becoming involved in managing projects/teams

  • Managers of Lead CRAs, Team Leaders, Project Managers, Clinical Project Coordinators


TYPE

In Person Training – At IMARC or Your Location


CEUs

7.0 hours (0.7 CEUs)


KNOWLEDGE LEVELS:

Intermediate
Advanced


WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References (Whitepapers and Infographics)
  • Certificate of Completion
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