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Clinical Research Professional Workforce Training Program

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Join the growing, dynamic field of clinical research


Program Overview

The Clinical Research Professional (CRP) Workforce Training Program at UTHealth Houston prepares trainees for a career as a clinical research professional. The program is 100% online and open to anyone interested in expanding their career in clinical research. The 28-week program is divided into three 8-week courses, with a 2-week break between each course.

The three courses must be taken sequentially and are designed to cover an introduction to clinical research concepts, the study initiation process, and clinical research study management. The curriculum has been developed utilizing competencies based on the Core Competency Framework for the Clinical Research Professional developed by the Joint Task Force for Clinical Trial Competency. (Core Competency Framework for Clinical Research Professional)

Program content will be delivered using slide presentations, lectures, textbook and article readings, case study analysis, and guest speakers who are experts in the field. Experiential or practical components are integrated into each course. Upon completion, each trainee will be granted a certificate of completion.

Registration for this program has closed.

Course 1: Fundamentals of Clinical Research

August 19 – October 13, 2024

In this introductory course, trainees will be given a comprehensive overview of the clinical research process and related concepts, including the fascinating history of clinical research and the decisive events that shaped the standardization of research conduct and human subjects protections as we know them today. They will also explore the drug development process, types of study design, research sites, team roles, and relevant terminology. Additional topics will include the regulations and guidance governing the conduct of clinical research, the ethical issues associated with human subjects research, and the global Good Clinical Practice standards. For context and real-world application, trainees will delve into case studies to examine ethical issues related to informed consent and Institutional Review Board approval.

By the end of Course 1, trainees will be able to:

  • Explain the concept of clinical research
  • Describe the process of medical product development in the United States
  • Differentiate the types of clinical research studies
  • Examine historic events that led to standardization of clinical research conduct
  • Describe the core ethical principles, regulations, and guidelines that ensure human subjects rights and protections
  • Explain the significance of the informed consent process

Course 2: Clinical Study Management I

October 28 – December 22, 2024

In this course, trainees will be provided with the concepts and tools required to begin a clinical research study. Topics will include research protocol development, feasibility evaluation, study budget development and management, IRB and regulatory submissions, study recruitment planning, clinical study initiation visit, and maintenance of essential documents. Trainees will engage in practical applications, including a protocol-specific worksheet activity, budget development, and the recruitment plan for the assigned protocol. 

By the end of Course 2, trainees will know how to:

  • Outline the steps involved in the study initiation process
  • Evaluate a clinical research protocol
  • Develop an informed consent document
  • Apply the principles of study budget development
  • Identify essential documents for clinical research
  • Develop the steps for developing a clinical research database.

Course 3: Clinical Study Management II

January 6–March 2, 2025

In the final course, trainees will explore concepts related to the management and coordination of the initiated clinical research study. Topics will include recruitment and screening of research participants, obtaining informed consent for research, study coordination, research compliance, investigational product, reporting adverse events, data collection and management, and study oversight. Real-world application activities will include evaluation of simulated informed consent and study visits, mock eligibility screening, and adverse event evaluation.

By the end of Course 3, trainees will be able to:

  • Discuss the elements of clinical research coordination
  • Evaluate a participant for study eligibility
  • Analyze unanticipated problems and adverse events
  • Transcribe source data into electronic case report form
  • Describe and differentiate the types of study oversight and how to prepare for each
  • Conduct a simulated informed consent process visit

The curriculum is consistent with the content areas of the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) basic certification exams. Trainees with one year of clinical research experience will be eligible to sit for the SoCRA certification exam, and those with two years of clinical research experience will be eligible  to sit for the basic ACRP certification exam.

Faculty

Dr. Brandi Showalter

Brandi L. Showalter, PhD, RN, CCRP

Assistant Professor of Nursing
NTI Department of Undergraduate Studies
Cizik School of Nursing
713-500-2217
Dr. Showalter has more than 25 years of nursing experience, primarily in clinical research nursing. She has also worked in critical care, med/surg, oncology, and psychiatry. Dr. Showalter played an essential role in the development and implementation of a Research Nurse Residency for newly graduated nurses. She has authored multiple peer-reviewed publications and has presented on her doctoral research, Moral Distress in Clinical Research Nurses, and the Research Nurse Residency at several conferences.

Staff

Shwetha Pazhoor, MS, CCRP

Senior Research Compliance Specialist
Clinical Trials Resource Center
713-500-3578

Program Cost

The cost of the 2024-25 program is $4800, and must be paid in full by August 5, 2024. Payment details will be emailed upon registration. 

Financial Assistance

In many cases, employers will cover all or part of the cost of a professional development program if it is related to an employee's position. Be sure to check with your manager or HR department to find out if this program is eligible for coverage.

If your employer does not cover the cost of the program and you are having difficulty paying the entire amount, please contact us.

Registration for the Clinical Research Professional Workforce Training Program has closed.

Registration for the Clinical Research Professional Workforce Training Program has closed.

For questions regarding registration, contact Shwetha Pazhoor, MS, CCRP, Senior Research Compliance Specialist at [email protected]