Join the Thriving Clinical Trials Industry
Conducting clinical research is essential to ensure the safety and efficacy of new drugs, biologics and medical devices. Following pre-clinical development, clinical trials require careful planning and cooperation among a variety of professionals within the pharmaceutical/biotechnology industry, clinical practice, and government agencies. From phase 1 (first in humans) to phase 4 (post-marketing) and every phase in between, clinical trials professionals need both specialized expertise and universal familiarity with a variety of procedures.
By learning key concepts, guidelines, regulations, and best practices, participants in the Clinical Trials Design & Management certificate program gain the skills needed to become part of an active clinical research workforce.
*In-class options might be available for some courses.
$4,500 - $5,200
*Varies by course selection.
6 - 24 months
*Varies by student and courses taken per quarter.
What You Will Learn:
- Develop substantive knowledge about coordinating and managing a clinical trial, including the drug development process, human subjects protection, working with institutional review boards (IRBs), and application of good clinical practice regulations and guidances from both FDA and ICH perspectives.
- Learn how to set up a new clinical study; how to monitor clinical trials; as well as when, why, and how to engage clinical research organizations (CROs).
- Build or reinforce essential skills, such as data management, site and investigator recruitment, and project management.
- Discover a new understanding of oncology clinical research, from the basic science of cancer, to monitoring oncology trials.
- Gain an overview of the entire clinical research process to identify the various career paths within the industry.
- Be a part of a top-rated training program developed by leaders in the biotechnology/biomedical research industry.
Who Will Benefit:
The demand for highly trained professionals to coordinate and manage clinical trials for the local, national and global biomedical and biotech communities continues to grow rapidly.
- Managers in training and others who want to refine or update skills
- Research associates and coordinators
- Biomedical and research scientists
- Nurses and allied health professionals
- Statisticians and database administrators
- International clinical trials professionals
- Individuals with degrees in science, psychology or related areas who are entering the field
- All courses offered are approved to fulfill eligibility requirements for the Certified Clinical Research Associate (CCRA) or Certified Clinical Research Coordinator (CCRC) credentials through the Association of Clinical Research Professionals (ACRP). Visit ACRP at www.acrpnet.org.
- This certificate program has been evaluated and found to meet the current waiver requirement established by ACRP to waive 1,500 hours of hands-on experience performing the Essential Duties of the program to which the candidate has made application. (NOTE: Due to a recent change in ACRP policy, this waiver is active through December 2021. Students must have both completed the certificate program before or in 2021 and have also applied for the ACRP exam in 2021 for the waiver to apply).
- Extension’s certificate applies to Category 3 of Candidate Eligibility for the Society of Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) credential. Visit the Society of Clinical Research Associates (SOCRA) at www.socra.org.
There will be a $95 fee upon acceptance into the program