Clinical Research Professional Courses

Program Description: Beginner/Intermediate/Advanced

1. What Do We Mean by Broadening Recruitment in Clinical Trials?
2. FDA Initiatives to Broaden Participation in Clinical Trials
3. Clinical Trials Participation: Understanding the Needs and Importance of All Populations
4. Broadening Participation in Clinical Research
5. Population on the Fringe of Clinical Trial Enrollment
6. Expanding Participant Access and Involvement in Clinical Research

Program Description: Beginner/Intermediate/Advanced - Learner Level

There are thousands of job opportunities in clinical research. For those seeking an initial career in this field or switching professions, how does one “get their foot in the door”? In this program, experts from the medical device industry and academic medical institutions will provide comprehensive insights into various clinical research fields, and necessary core competencies for professional growth and pathway advancement. At the end of this program, participants will gain perspectives and insights in various clinical research fields, and the required skill sets, background experiences, education, and resume building skills to acquire positions as a clinical research professional.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (4.25 Total Contact Hours).

Courses:

1. From Academics to Industry – A Physician Research Perspective
2. Clinical Supply Chain Management: Dude, Where’s My Patient Benefit?
3. Understanding Clinical Research Management at Academic Institutions  
4. Roads to the Human Subjects Protection Program (OPRS and IRB)
5. Knocking on HR’s Door: Do you have what it takes to be a CRP?

Program Description: Intermediate/Advanced - Learner Level

This 5-course program features industry and academic experts discussing the integral role of statistics in medical product development, specifically in clinical trial design. This program provides a foundational understanding of statistical topics related to clinical research in an interactive forum. Statistical principles such as power, multiplicity, and P-values remain critical in designing successful clinical trials. Statistical techniques determine the number of patients needed for a study to meet a pre-set clinical endpoint and to generate meaningful results. While analyses can reveal mathematically significant, this does not always equate to clinical or medical value.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (4.1 Total Contact Hours).

Courses:

1. Basic Statistical Principles: Validity and Sample Size
2. Designing Medical Devices
3. Pediatric Trials
4. CTSI Clinical Study Design Types
5. Gender, Race, and Ethnicity in Clinical Trials

Program Description: Intermediate- Learner Level

This program, comprised of five courses, features industry and academic experts discussing the role and impact of technological advancements in the medical device industry.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (5.5 Total Contact Hours).

Courses:

1. What is Digital/AI/Machine Learning? How is it Used?
2. Clinical Virtual Reality: Seven Ways that Virtual Reality Will Change the World of Mental Healthcare!
3. Regulatory Framework for the Digital World
4. Use of AI in Drug Development
5. Cybersecurity

Program Description: Intermediate/Advanced

Genomic DNA analysis provides vital insights into the etiology of diseases. Researchers in the field of regenerative medicine leverage this knowledge to develop therapies to address unmet medical needs, thereby translating scientific understanding into potential treatments for individuals.

Program Goal: This program will enhance the participants comprehension of the processes involved in developing, manufacturing, and regulating these therapeutics, ensuring their safety and efficacy.  

Courses:

1. Regulatory Aspects of Cell Therapy and Regenerative Medicine
2. Translational Approach and Use of Stem Cells for Arthritis and Cartilage Restoration
3. Cell Therapy Manufacturing
4. The Marriage of Ophthalmology and Bioengineering
5. Target Identification for Gene Therapy

Program Description: Intermediate/Advanced - Learner Level

This program is comprised of five courses featuring industry experts discussing the role of genomics in medical product development, a rapidly evolving field of science with new technologies and emerging applications.

Genomics science continues to play a major role in generating new knowledge in the basic research arena. How these learnings translate into product development involves the integration of genomics data, including pharmacogenomics and “Big Data,” and data extraction for mathematical models, such as drug-disease-trial models, into the regulatory decision-making process. This program will introduce and examine these topics in an interactive forum with an emphasis on innovation and translation. This course is designed to increase understanding of regulatory framework and policies for FDA regulated genomics products. 

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (5.75 Total Contact Hours).

Courses:

1. Genomics and Regulations
2. Genomics and Personalized Medicine
3. Pharmacogenomics Considerations for Clinical Research and Implementation
4. Big Data and Genomics
5. Applied Genomics and Target Identification

Program Description: Intermediate/Advanced - Learner Level

Approaches to testing the efficacy and safety of innovative therapies requires regulatory agencies adapt her policies for appropriate oversight. Insights on the FDA’s current regulatory interests will be provided along with an exploration of various adaptive and innovative study designs.

Program Goal:

This program will enhance the participants comprehension of regulatory trends related to components of clinical trial design including diversity, study endpoints, and more.

Courses:

1. Regulatory Trends
2. Statistical Challenges of Adaptive and Innovative Study Designs

Course Description: Beginner - Learner Level

This 4-part program builds learner knowledge and expertise in the interpretation of Clinical and Translational Research (CTR) literature using written and supplemental materials, videos, interactive graphics, and self-assessment.

• Part 1: Understanding the Translational Science Research Ecosystem
• Part 2: Basic Concepts Defining the Analytic Approach to Research
• Part 3: Elements of Clinical and Translational Research Studies
• Part 4: Clinical and Translational Research Study Design Types

Complete the 4-part program and earn a continuing education certificate. (6.0 Total Contact Hours).

Development of this program was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award number UL1TR002378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Courses/Program: 

1. Introduction to Clinical and Translational Research

Course Description: Beginner 

In this course, we will explore strategies that are effective in reaching and engaging all learners. The session provides a comprehensive, 360-degree introduction to Universal Design for Learning (UDL), a research-based framework designed to improve and optimize teaching and learning for all students. Through an in-depth exploration of UDL principles, participants will learn how to create ideal learning environments that support the widest range of learners.

Course Description: Beginner 

This course introduces learners to the HET, a free and open-source platform developed by the Satcher Health Leadership Institute at Morehouse School of Medicine. Its goal is to equip communities, policymakers, and health professionals with the tools and knowledge to better understand and act on health care access.

Key concepts such as cross-section analysis and ethical data use are emphasized to promote responsible, application of health information. Learners will also gain practical insights into how different stakeholders — including providers, community leaders, and policymakers — can engage with data in ways that align with their decision-making needs.

Course Description: Intermediate/Advanced

In this course on Interprofessional Education and Collaborative Practice we will first consider the history and background of Interprofessional Education. Then we will dive deeper into the four collaborative practice (IPECP) competencies:

Competency Domain 1: Values/Ethics for Interprofessional Practice

Competency Domain 2: Roles and Responsibilities

Competency Domain 3: Interprofessional Communication

Competency Domain 4: Teams and Teamwork

Course Description: Beginner/Intermediate

This educational module provides a foundational understanding of the complex web of factors that influence health outcomes and access to care.

Course Description: Beginner/Intermediate

In this module, we will review high-level concepts centering on health policy and health systems transformation. This module provides an overview of key terminology and frameworks in the context of health policy, while also examining strategies for policy for creating, changing, and improving health policy at any level of impact. Finally, this course will review a long-term federal program and the policy from which it is enacted to highlight the complex and dynamic nature of health policy and policy change.