Clinical Research Coordinator Training Program

About the CRCTP

 

• 10-week program with half day lectures and two-weeks of half-day in-person clinical shadowing sessions.
• Lectures will be a hybrid format with in-person lectures and online training modules.
• CRC Trainees will have to complete a mid-term and final exam to receive their certificate.
• Scheduled to start in Summer 2024.

 

Targeting Audience

Candidates that have successfully completed lower division courses in biology, chemistry, or the SCRC stem cell techniques course. This program will also be beneficial for new clinical research coordinators as they start their clinical research career at UCI. We hope to enroll 10-20 candidates each session.

At The tuition for this program will be $5,000 USD and need to be paid by the candidate or their clinic. Scholarships are available.

 

Program Objectives

• To develop and train clinical research coordinators in cell and gene therapy clinical trials.
• To introduce CRC job responsibilities and impart practical skills to aid in their day-to-day roles.
• To expand knowledge of clinical research coordinators including best practices for documentation, informed consent process, data management and security, IRB and IBC, and coverage analysis.

 

Curriculum

During the program, trainees will learn a wide breadth of topics related to all aspects of conducting clinical trials and the responsibilities of a CRC that will make them competitive in the high demand environment as they pursue or continue their career in clinical research.

• CRC Introduction
  • Human subjects research, Health Insurance Portability and Accountability Act (HIPPA), Good Clinical Practices
    
• Informed Consent and Data Management
  • The Informed Consent Process, Adverse Event/Serious Adverse Event Reporting, Research Shadow Chart, Electronic Data Capture, and Data Management
• Subject and Data Review, IP Accountability
  • Pre-screening and Screening Procedures, Interim Monitoring Visits, Lab and Specimen Management, IDS Pharmacy, CRC Investigational Product/Drug Handling and Accountability
• Study Start Up & Post Award
  • Study Start Up Package, Confidential Disclosure Agreement, Clinical Trail Agreement, and Budget, Overview of the OnCore Clinical Trial Management System, Sponsor initiated Protocol Amendments and Updates, Post-Award Billing, Subject Compensation, or Reimbursements
• Investigational New Drugs
  • Types of Investigational New Drugs (INDs), the Application Process, INDS Modifications, Safety Reports and Annual Reports, IND Emergency Use, Expanded Access, Exemptions, and Investigational Device Exemptions (IDEs), Investigational Statement Form 1572, Conflicts of Interests/Financial Disclosures, Training/Delegation Logs
• Clinical Research Ethics
  •  (Institutional Review Board, Institutional Biosafety Committee, Stem Cell Oversight Committee (hSCRO), Ancillary Committees, Protocol Training, Research Agreements & Standard Operating Procedures, Research Revenue Integrity
• Cell and Gene Therapies
  • Stem Cells, CAR-T Cells, Gene Therapies, Neurosurgical Approaches to Transplantation

 

Assessment Plan

There will be four categories of assessments throughout the program:

• A midterm and trainees are required to obtain a minimum score of 80% to pass.
• A cumulative final following the last lecture and trainees are required to obtain a minimum score of 80% to pass.

 

Upon completion of all assessments with passing scores, each trainee will earn a certificate from the UCI School of Medicine Division of Medical Education

 

 

Required Application Documents

1. Completed application form – Click the “Apply Now” icon below to access the online application.
2. Resume (Word or PDF preferred)
3. Curriculum Vitae (CV) (optional) (Word or PDF preferred)

 

 

 

If you have any questions about the program, please contact:
Yuna Muyshondt ( chuny@hs.uci.edu ), Mihaela Nistor ( mnistor@hs.uci.edu ), or Dr. Monique Williams ( monique.williams@uci.edu )