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 100% online 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. All assignments are completed via Blackboard, where learning materials are available for students to complete on a computer at their own pace. There are no scheduled meeting times for classes.
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 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 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
Clinical Research Specialist Courses
Healthcare Clinical Research Specialist
Course Objectives
Define the terms associated with clinical research
Define the structure of a clinical trial
Define clinical trial roles and key players
Discuss basic regulations 21 CFR and ICH E6 and history of regulations
Discuss informed consent and financial disclosure requirements
Discuss Institutional Review Boards and essential regulatory documents
Define data management
Define clinical data and source data
Discuss the Case Report Form and how data is collected
Discuss and define data review: medical history, adverse event, concomitant medications and physical exam
Discuss and define the clinical database and edit check process
Write and answer data queries
Discuss basic statistics used in clinical research
Define and discuss scientific misconduct
Cite the requirements for successful subject recruitment
Discuss the roles and responsibilities of clinical site staff
Outline of Instruction
Introduction to Clinical Trials: Components of a Trial and Trial Roles (YouTube video lecture) Discuss syllabus, online environment and what is being studied: new drug (NME), device (nonmetabolized), Phase I-IV clinical site, PI, coordinator, lab, nurse, clinical trial office. Read: Chapter 1 of "Lessons from a Horse Named Jim," Nuremberg Code, Declaration of Helsinki, Belmont Report introductions. Find an article.
Good Clinical Practice (YouTube video lecture). FDA 21 CFR regulations ICH E6 guidelines. Read: FDA Regulations Overview - Hirschfield PowerPoint. Scan this website and the following sections of FDA Regulations related to clinical trials: 21 CFR 11 - Electronic Records, 21 CFR 50 - Protection of Human Subjects, 21 CFR 54 - Financial Disclosure, 21 CFR 56 - Institutional Review Boards, 21 CFR 312 - Investigation New Drug Application (IND), 21 CFR 314 - New Drug Application (NDA). All can be found at https://www.fda.gov/science-research/clinical-trials-and-human-subject-…. Read 21 CFR 312 - Investigational New Drug Application (IND) Subpart D - Responsibilities of Sponsors and Investigators. Scan ICH-GCP E6 Sections 2-5, pages 80-95 of the textbook. Read ICH-GCP E6, Sections 4 and 5, pages 83-93. Compare and contrast the FDA and ICH regulations.
Informed Consent Process (YouTube video lecture) Read: "Consent Issues in Human Research," pages 197-201, "Is Informed Consent Always Necessary?" pages 207-210, "Subject Interview Study," pages 213-216, "False Hopes and Best Data," pages 216-221, "Therapeutic Misconception in the Informed Consent Process," pages 221-223. Review ICF.
IRBs (YouTube video lecture). Read: "Monitoring Clinical Research," pages 425-429, 21 CFR 56 - Institutional Review Boards, Summary of Historical Documents
Responsibilities of Investigators (YouTube video lecture). Read: "Use of Human Tissues in Research," pages 311-312, "Drug-Free Research in Schizophrenia," pages 329-331, "Protecting Communities in Research," pages 340-341, "Protecting Communities in Biomedical Research," pages 342-343, "Ethical Imperialism?" pages 356-357, "Part 8: The Behavior of Clinical Investigators," pages 369-374, "Uderstanding Financial Conflicts of Interest," pages 375-377, "Finder's Fees for Research Subjects," pages 377-378, 21 CFR 54 - Financial Disclosure, "Finder's Fees - Good or Bad, Financial Disclosure - Necessary or Not.
The Clinical Site (YouTube video lecture) Read: Chapters 8, 10 and 11 of "Lessons from a Horse Named Jim. Exam 1.
Subject Recruitment (YouTube video lecture). Develop at recruitment plan and the research subject population. Read: Develop a Recruitment Plan, page 219, "Lessons from a Horse Named Jim." Discuss a recruitment strategy.
Data Management Roles and the Data Management Plan (YouTube video lecture). Discuss the history of the DMP. Discuss the topics covered the DMP - page 4. Discuss the supporting documents of the DMP and how they are used. Read: Chapter 1: The Data Management Plan and Appendix A: Data Management Plan Outline. Answer questions on the discussion board and discuss a component of the DMP.
CRF Design Entering and Reviewing Data (YouTube video lecture). Explain rules for creating CRFs. Discuss database design and the use of edit checks to clean data (Chapter 4). Review samples of CRF pages for flaws or potential errors. Read: Chapter 2: CRF Design Considerations. Discuss how data is reviewed from the CRF to the clinical database. Discuss edit checks and the edit specs document. Read: Chapter 4: Edit Checks and Chapter 6: Receiving Data on Paper. Two considerations for working with CRFs and avoiding transcription errors.
MH/AE/CM/PE Entering Data onto CRF Pages (YouTube video lecture). Lots of discrepancies live in these pages. Discuss the relationship between these three types of log pages. Read: Chapter 11: Collecting Adverse Event Data. Enter CRF data exercise. Why is collecting AEs important?
Cleaning Data Query Writing and Resolution (YouTube video lecture) Discuss: Data discrepancies, different types of queries. Read: Chapter 8: Cleaning Data. Write and resolve query examples, learn importance of query writing and resolution.
CDMS Coding Dictionaries (YouTube video lecture) Discuss: CDMS systems. Read: Chapter 19: Clinical Data Management Systems. Discuss: EDC Systems. Read: Chapter 20: EDC Systems. Discuss: Different coding dictionaries, such as MedDRA, WHODrug, etc. Read: Chapter 26: Coding Dictionaries and Systems.
In your words, what is the principal reason why the use of coding dictionaries is important in clinical trials?
DM Standards and Statistics (YouTube video lecture). Discuss CDISC and CDASH. Read: Krishnankutty, B., Bellary, S., Kumar, N. B., & Moodahadu, L. S. (2012). "Data management in clinical research: An overview." Indian Journal of Pharmacology, 44(2), 168-172. Introduction to Medical Statistics (https://www.youtube.com/watch?v=x8one-B_Y1w).
Go back to your article from Week 1 and determine which statistical assessments would be used to come up with the conclusions. Search online for statistics sites for help. Post your response on discussion board. Exam 2
Ethics of Trial Design (YouTube video lecture) Read: Placebo Controlled Trials, pages 137-140, The Ethics of Placebo-Controlled Trials, pages 140-144, The Changing Landscape of Human Experimentation, pages 146-151, Why Use Women and Minorities in Clinical Trials?, pages 171-175. Is the use of placebos ethical or not?
Special Populations (YouTube video lecture) Read: Part 6 Clinical Research with Special Populations, pages 225-228, Research Involving Persons with Mental Disorders, pages 229-233, Caring about Risks, pages 237-240, Convenient and Captive Populations, pages 258-262, Reverby, S. "Ethical Failures and History Lessons: The U.S. Public Health Service and Research Studies in Tuskegee and Guatamala," 18 pages. What would be your principal concern about working with special populations?
Scientific Misconduct (YouTube video lecture, "60 Minutes" segment about Dr. Anil Potti at Duke - https://www.cbsnews.com/news/deception-at-duke-fraud-in-cancer-care) Read: Gewin, V. (2012). Research: "Uncovering Misconduct," Nature, 485(7396), pages 137-139, "Pressure to Publish and Fraud in Science," pages 393-395, "Preventing Scientific Misconduct," pages 399-402. Based on what you learned from the articles and in class, what should you be alert to with regard to scientific misconduct and how should you best respond to it?
Database Lock and Study Closeout (YouTube video lecture) Discuss database lock, what happens after database lock and data safety management boards. Read Chapter 13 (Study Database Lock) and Chapter 14 (After Database Lock). Exam 3
Wrap-up with at least two industry guest speakers discussing data management and drug development initiatives. Student reflections on getting the most out of you career in clinical research.
Contact Hours
108
CEUs
1
Industry Standard, State or National Certification
Certification
Society of Clinical Research Associates (SOCRA)
Website
Certification Learning Outcomes/Requirements
The Certified Clinical Research Professional (CCRP) exam is available for individuals who meet 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 a degree in Clinical Research from an associate, undergraduate or graduate degree program and have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a clinical research professional; hold an undergraduate or graduate certificate in Clinical Research with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) and hold an associate or bachelor's degree in a science, health science, pharmacy or related field and have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a clinical research professional.
CE or CU Articulation
No
Prerequisites
Background in science is preferred
Learning Supplies Needed
Please see class details for the required textbook and/or supplies
Clinical Site/Special Facilities
Computer with internet access
Requirements for Successful Completion
100% attendance
Full participation in each weeks' online assignments and discussion forum. Students will post weekly responses to discussion forum questions designed to assess their learning of the week's instructional content
Accreditation/Special Approval Requirements
N/A
Intended Audience
Individuals entering or progressing in a career in clinical research and students with education and training in the clinical trials field seeking professional certification offered by one or more of the skills-certifying organizations.
Specific Industry or Business Support Needs
Clinical research specialist, clinical research assistant, clinical research associate, clinical trials assistant, clinical trials specialist
Wake County Need for Industry Positions
The Triangle area is world headquarters for clinical research activities. In addition to the local pharmaceutical companies that call North Carolina home, the area includes large operations of the world's top contract research organizations, including IQVIA, PPD, Parexel, ICON and Syneos Health. These companies employ tens of thousands globally and thousands locally.
Industry or Job Titles Related to Training Outcomes for Employment
Related Courses
Course Contact Information
Health Science Non-Degree Programs https://cehealth.waketech.edu
919-747-0140
[email protected]
| Details | Section | Date(s) | Location | Price | Seats | |
|---|---|---|---|---|---|---|
| 319098 | 02/02/26 - 06/07/26 | Online | 180.00 | 23 | Register |
If you would like to be notified when additional sections become available, please use Wake Tech's Notify Me service.
Monitoring Clinical Trials
Course Objectives
Compare and contrast types of monitoring visits
Cite ICH and FDA requirements for monitoring
Discuss the role of the monitor
List and discuss the essential documents collected at study startup
Describe the site activation process
Cite requirements for monitoring confirmation letters
Prepare a site monitoring plan
Review essential documents for regulatory compliance
Describe and discuss the informed consent process
Cite staff training requirements
Cite the requirements for safety reporting
Complete source data verification (SDV)
Compare and contrast source data verification and medical review
Assess adverse events and serious adverse events
Discuss investigational product (IP) accountability
Discuss remote monitoring fundamentals
Describe protocol deviations and reporting requirements
Discuss site communication requirements and techniques
Prepare for life on the road
Complete the practice monitoring visit
Write monitoring trip report and follow-up letter
Outline of Instruction
Introduction to Monitoring
Study Start Up
Conducting the Monitoring Visit
Reviewing the Regulatory Binder
Staff Training and Qualifications
Source Data Verification, Medical Review, and Informed Consent
Safety and Patient Protection
Investigational Product and Supplies
Principal Investigator Oversight
Remote Monitoring
Protocol Deviations and Violations
Clinical Team Structure and Communicating with Your Sites
Organizing Your Work - Your Life on the Road
Advancing Your Monitoring Skills and Training
Practice IMV visit
Contact Hours
96
CEUs
1
Industry Standard, State or National Certification
Certification
The Society of Clinical Research Associates, Inc
Website
Certification Learning Outcomes/Requirements
Certified Clinical Research Professional (CCRP) exam is available for individuals who meet 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 a degree in "Clinical Research" from an Associate, Undergraduate, or Graduate Degree Program AND Have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a Clinical Research Professional
-Hold an Undergraduate or Graduate Certificate in "Clinical Research" with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) AND Hold an Associate's or Bachelor's Degree in a science, health science, pharmacy or related field AND Have completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional.
CE or CU Articulation
No
Prerequisites
Students must have taken CTR3110A3 Healthcare Clinical Research Specialist or have one year experience working in a Clinical Research setting as an associate or assistant
Learning Supplies Needed
Please see class 'details' for required textbook and/or supplies
Clinical Site/Special Facilities
n/a
Requirements for Successful Completion
90% attendance
Students must receive a minimum score of 80 on each exam
Accreditation/Special Approval Requirements
N/A
Intended Audience
This course is designed for individuals who have been working in the Clinical Research industry or have taken CTR3110A3 Healthcare Clinical Research Specialist and would like to further their knowledge and career path into Clinical Trial Monitoring
Specific Industry or Business Support Needs
Clinical Research Monitor
Clinical Research Associate
Wake County Need for Industry Positions
Wake County (RTP) is world headquarters for clinical research. A search on NC Works shows numerous Clinical Research Associate positions
Industry or Job Titles Related to Training Outcomes for Employment
Clinical Research Monitor
Clinical Research Associate
Related Courses
Course Contact Information
Health Science Non-Degree Programs https://cehealth.waketech.edu
919-747-0140
[email protected]
| Details | Section | Date(s) | Location | Price | Seats | |
|---|---|---|---|---|---|---|
| 325626 | 01/05/26 - 04/26/26 | Online | 180.00 | 25 | Register | |
| 320433 | 01/07/26 - 04/26/26 | Online | 180.00 | 25 |
Course Cancelled
|
If you would like to be notified when additional sections become available, please use Wake Tech's Notify Me service.
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
Certification
Association of Clinical Research Professionals
Website
Certification Learning Outcomes/Requirements
Certified Clinical Research Coordinator, ACRP
CE or CU Articulation
No
Prerequisites
None
Learning 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
100% 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
Allied Health Office https://cehealth.waketech.edu
919-747-0140
[email protected]
| Details | Section | Date(s) | Location | Price | Seats | |
|---|---|---|---|---|---|---|
| 320466 | 01/12/26 - 05/03/26 | Online | 180.00 | 23 | Register |
If you would like to be notified when additional sections become available, please use Wake Tech's Notify Me service.
