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CLINICAL RESEARCH TRAINING

CLINICAL PROJECT MANAGER: COMPREHENSIVE TRAINING

COURSE DESCRIPTION:

The goal of this three-day training is to provide a comprehensive overview of the project management role and responsibilities. This course will provide new or aspiring clinical research project managers with the skills as well as necessary tools and processes to successfully manage projects in clinical research settings. The course review the FDA regulations and GCP, emphasizes the differences between key roles in clinical research, and provides tools to aid in application of clinical project management concepts and principles.

LEARNING OBJECTIVES:

  • Review FDA regulations and ICH GCP E6 Guideline for Good Clinical Practice (GCP)

  • Describe project management as it applies to clinical research and in the management of clinical trials

  • Develop a monitoring plan which focuses on mitigating risks at both the program and study levels

  • Utilize effective communication and leadership skills for successful study management

COURSE OUTLINE

DAY ONE 8:30 am - 4:30 pm

  • Clinical Research Studies Refresher

    • Good Clinical Practice and U.S. FDA Regulations Refresher

    • Comparing Drug and Device Development Pathways

    • INDs vs IDEs: Comparing 21 CFR Parts 312 vs. 812

  • FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions

  • Day to Day Differences in Medical Device Studies vs Investigational Drug Studies

    • Adverse Event Reporting and Product Complaints: “Is It Reportable?”

    • Product Accountability: “Where does the Pharmacy fit?”

    • Special Considerations for Securing Compliance

  • Debate Club: Notes-to-File, Delegation Logs, Consent Notes

    • Thinking Critically about Requirements, Best Practices, and Pitfalls

  • Key Roles and Responsibilities in Clinical Research Overview

    • Project Manager, Monitor, Primary Investigator, Clinical Research Coordinator, Data Manager and Statistician

  • Risk-Based Monitoring (RBM)

    • RBM Overview: FDA Guidance and ICH GCP E6

    • Developing Monitoring Plans: Planning and Implementation

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

DAY TWO: 8:30 am - 4:30 pm

  • Clinical Research Project Management: Planning

    • Creating the Project Plans and Work Breakdown Structure

    • Assessing Risks and Developing Mitigation Strategies

    • Project Budget Considerations: Planning and Oversight

    • Assembling and Training the Sponsor Team

  • Clinical Research Clinical Project Management: Start-up

    • Vendor Selection and Management

    • Developing Study Documents and Site Files

    • Site Assessment and Selection

    • Site Start-up and Initiation

  • Research Off the Rails: Getting Your Clinical Study Back on Track

    • “What do I do when I realize there is a problem?”

 

DAY THREE: 8:30 – 4:30 pm

  • Ongoing Project Management: Documentation

    • Maintaining the Sponsor TMF

    • Documentation in Clinical Research for Sites: What is REALLY Needed

  • Ongoing Project Management: Tools, Strategies, and Effective Communication

    • Effective Metrics: Benefits for Tracking Clinical Study Details

    • Schedule and Time Management

    • How to Run Effective Meetings: 8 Steps to a Successful Meeting

    • Leading Teams: Managing Difficult Personalities and Having Challenging Conversations

  • Ongoing Project Management: Vendor Oversight and Expectations

    • What Does GREAT Monitoring Look Like?: “Take Your Team’s Monitoring from GOOD to GREAT!”

    • Excellent Monitoring Reports: What to Look For?

    • Follow-up and Follow Through: Ensuring Effective Site Management by Vendors

    • Working with Your Monitors to Ensure Timeliness, Quality, and Study/Site Compliance

  • Project Close-Out: Getting to the Finish Line

  • Project Management in Practice: 5 Things That Aren’t (Normally) Taught in PM Class

 

TYPE

  •  In Person Training – At IMARC or Your Location
  • Hybrid training: web-based courses plus in-person training
     
CONTINUING EDUCATION CONTACT HOURS (CEUs)
14.0 hours (1.4 CEUs)

KNOWLEDGE LEVELS:

  • Beginner
  • Intermediate

WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References
  • Certificate of Completion
 

Training Solutions For These Roles

  • New clinical research Project Managers

  • Experienced Project Managers without formal project management training

  • Newly hired Clinical or Project Leads who will be managing at the sponsor, CRO, or investigational site

  • Clinical Research Associates, Data Managers or other research personnel interested in transitioning into a Clinical Project Management role

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