Clinical Research Specialist
The Research Triangle region is a global hub for clinical research activities. Become part of this vibrant industry by preparing to work as a clinical research monitor or clinical trials associate. The program covers the fundamentals of monitoring clinical trials, including the regulatory requirements for monitoring, how to conduct site visits and how to report findings to sponsors.
The program is online, and all hours will be completed via Blackboard, where assignments and learning materials will be available for students to complete from their computer at their own pace. There are no scheduled meeting times for classes.
Students should be proficient in keyboarding, have a basic understanding of a word-processing computer program (Microsoft Word recommended) and have a command of English grammar and punctuation. A science background is recommended, but not required.
The Certified Clinical Research Professional exam, offered through the Society of Clinical Research Associates, is available for individuals who meet any of the following criteria:
- Have two years of experience as a full-time clinical research professional (or have 3,500 hours part-time) during the last five years
- Hold an associate, undergraduate or graduate degree in clinical research and have at least one year of full-time experience (or 1,750 hours part-time) as a clinical research professional during the past two years
- Hold an undergraduate or graduate certificate in clinical research with at least 12 credit hours of study, or a total of at least 144 credit hours, from a community college, college or university and hold an associate or bachelor's degree in a science, health science, pharmacy or related field and have at least one year of full-time experience (or 1,750 hours part-time) as a clinical research professional during the past two years
Industry-recognized credential: Society of Clinical Research Associates
Complete in: Six months or less
Financial assistance available
Workforce Development offers financial assistance for many workforce training programs through the Propel program and other resources. Email [email protected] for more information.
Clinical Research Specialist Courses
Coordinating Clinical Research: The Role of the Clinical Research Coordinator
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
Contact Hours
96
CEUs
1
Industry Standard, State or National Certification
Association of Clinical Research Professionals
CE or CU Articulation
No
Prerequisites
None
Text and Supplies Needed
-The CRC's Guide to Coordinating Clinical Research, 4th Edition, by Sandra "SAM" Sather
-Computer with internet access
Clinical Site/Special Facilities
None
Requirements for Successful Completion
attendance"Complete weekly learning objectives and complete three exams in Blackboard."
Accreditation/Special Approval Requirements
N/A
Intended Audience
Those who wish to work in the role of a clinical research coordinator.
Specific Industry or Business Support Needs
Clinical Research Coordinator, Research Assistant
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to training Outcomes for Employment
Clinical Research Coordinator
Research Assistant
Related Courses
CTR-3110A3
CTR-3110B3
Course Contact Information
Samantha Bray
919-532-5844
[email protected]
| Details | Section | Date(s) | Location | Price | Seats | 311361 | 05/26/25 - 09/14/25 | Online | 180.00 | 15 | Register |
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