Course Offerings

Coordinating Clinical Research: The Role of the Clinical Research Coordinator

Course ID: CTR-3110C3
Overview
Course Outline
Requirements
Intended Audience
More Details

The Triangle area of North Carolina is world headquarters for clinical research activities. In addition to the local pharmaceutical companies that call NC home, the area includes large operations of the world's top contract research organizations (CROs) including IQVIA, PPD, Parexel, ICON, and Syneos.

One of the principal job roles for the industry is the clinical research coordinator (CRC). CRCs work at sites conducting clinical trials. Sites include Duke University, UNC-Chapel Hill, Wake Research Associates, as well as other smaller, independently owned research sites. CRCs work with doctors and other medical staff who conduct clinical trials on behalf of pharmaceutical and medical device companies.

This course provides training on the fundamentals of coordinating clinical research studies including regulatory requirements for adverse event reporting, data management, and subject safety. CRCs are in great demand. This course provides training for those who wish to transition into this role.

Course Objectives

Examine the clinical research process and ecosystem

Discuss the principles of Good Clinical Practice (GCP)

Describe the contents of the Investigational Site File (ISF)

Cite the regulatory requirements of sites and principal investigators

Discuss the purpose and function of Institutional Review Boards (IRB)

Discuss protocol deviations

Discuss the informed consent process

Cite the informed consent requirements according to ICH E6 GCP

Describe the role of contract research organizations (CROs) in the conduct of clinical trials

List the monitoring requirements of sponsors of a clinical trial

Cite the specific components and sections of a clinical trial protocol

Apply the fundamentals of data collection

Define the principles of good data management

Perform clinical data entry

Identify fundamentals of electronic data capture and data quality

Demonstrate ability to response correctly to data queries

Prepare a research budget

Define subject recruitment

Review investigational product accountability tracking and inventory

Review lab supplies inventory

Compare and contrast site management organizations

Identify research studies that match site's capabilities

Perform patient visit exercise

Outline of Instruction

The clinical research process and ecosystem

Introduction to Good Clinical Practice

The Investigator Site File or Regulatory Binder

Staff Training and Qualifications

Working with Institutional Review Boards (IRBs)

Creating informed consent documents

Working with Contract Research Organizations (CROs)

Planning Research

Principal Investigator Oversight and Responsibilities

Data collection, management, and electronic data capture (EDC)

Source Data Verification, Medical Review, and Informed Consent

Subject Recruitment

Investigational Product and Supplies Accountability

Laboratory supplies and fulfillment

Site management - The clinical research enterprise (the business of research)

Improving and advancing in the field

Practice patient visit