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.
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
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
TYPE
KNOWLEDGE LEVELS:
WHAT’S INCLUDED
ADDITIONAL WEB-BASED COURSE ADD-ONS
GCP & US FDA Regulations Refresher
Critical Thinking in Clinical Research
FAIR ShakeTM
Dealing with Difficult Sites
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
