Clinical Trials Coordination Certificate Program

Important Note About Registration

If you plan to complete this certificate program, you must notify Catherine Winslow (catherine.winslow@wright.edu) before registering for the courses.

Overview

The Clinical Trials Coordination certificate is designed to facilitate readiness for clinical trials and clinical research management and enactment. The certificate can also act as a stepping stone for enrollment into the Clinical Trials Coordination Master of Science degree program.This certificate, based on the Joint Task Force for Clinical Trial Competency (JTF) domains, provide a foundation in clinical research with the goals to protect research participants' welfare; improve global health; and coordinate academic, government, and industry research. This certificate helps students prepare for national certification through the Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP). The certificate is appropriate for post-baccalaureate and post-master's students in any academic field; e.g. business, education, engineering, liberal arts, mathematics, medicine, nursing, psychology, and sociology, among others.

Required Courses

PTX 8010 Clinical Research Roles & Responsibilities (3 credits). This required course offers a solid foundation in clinical research with the goals to protect the welfare of research participants, improve global health, and provide foundational knowledge and skills the student will need to become leaders in the field; whether working in academia, government, industry or other areas. Specifically, this course will help prepare the student to take the standardized ACRP or SoCRA Certification Exam. Emphasis on clinical trials related to drug protocol development, drug approval process, phases of clinical research investigation, U.S. Food and Drug Administration (FDA) rules and regulations, as well as business management, budgeting and marketing for clinical trials.
PTX 8140 Human Studies Research (3 credits). All research projects that involve human subjects require review and approval at the institutional level for both regulations covering human subjects research and/or regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). A well-crafted research proposal makes completion of the review process at each institution easier. In this class we will develop a petition, complete Collaborative Institutional Training Initiative (CITI) training, and engage in dialogue on the topic.

And either PTX 6003 or PTX 9200:

PTX 6003 Intro to Pharmacology (3 credits). This course provides an introduction to basic concepts in drug action. Students will become acquainted with the types of pharmacological agents, their general mechanisms for influencing cell behavior, the duration of effective action, and the vocabulary and delivery of pharmacological agents.
PTX 9200 Pharmacology Clinical Research (3 credits). This class is designed to give pharmacology and medical students supervised research involving human subjects. Students who enroll in PTX 9200 Pharmacology Clinical Research will experience mentored learning in active on-site WSU BSOM Pharmacology Translational Unit research studies. Students are required to complete 40 hours of hands-on clinic time at the PTU. Students who wish to complete PTX 9200 for their certificate must first complete and successfully pass PTX 8010 Clinical Research: Roles and Responsibilities.

Students interested in learning more about the fields of Clinical Trials & Clinical Research are encouraged to visit the following helpful links:

Association of Clinical Research Professionals

Joint Task Force for Clinical Trial Competency

Society of Clinical Research Associates

Merck Program Educates Youth on Value of Clinical Trial Careers

Admission Requirements:

To be admitted in the certificate program students need to meet Wright State School of Graduate Studies admission requirements.

How to Apply:

For more information about the certificate, please contact Dr. Terry Oroszi at terry.oroszi@wright.edu.

Last edited on 10/11/2022.