The following eight Core Competencies for Clinical and Translational Research, targeting principal investigators and clinical research coordinators, were developed by the Enhancing Clinical Research Professionals’ Training and Qualifications project.

  • Scientific concepts and research design
  • Ethical and participant safety considerations
  • Medicines development and regulation
  • Clinical trial operations
  • Study and site management
  • Data management and informatics
  • Leadership and professionalism
  • Communication and teamwork

ACRP (Association of Clinical Research Professionals) eLearning Module

The UC Davis CTSC offers ACRP e-learning programs recognized by (Transcelerate BioPharma), that include a wide variety of training topics on essential components of quality clinical research, plus multiple options for completing required GCP (Good Clinical Practice) training.

Clinical Research Training Classes

These modular courses are designed to enhance clinical research competencies at UC Davis. For the next Clinical Research Coordination classes offered to UC Davis employees, visit the CTSC calendar and search "CRC". When you find the class, click on the link to schedule.

  • CRC 1.0 - Introductory Course for Jr. Specialists and new CRCs (Clinical Research Coordinator)
    This foundational course is specifically designed for new staff. It combines didactic training with hands-on training experiences to provide a solid foundation in research knowledge. Key areas include IRB (Institutional Review Board), HIPAA (Health Insurance Portability and Accountability Act) Compliance, EMR (Electronic Medical Record) research functionality, and regulatory documents. Learners will have an opportunity to participate in hands-on experiences with regulatory binders and EMR technology. The course repeats several times per year to give an opportunity for new staff to attend. Eligible for a CTSC certificate of attendance.
  • CRC 2.0 - Advanced course
    Designed for investigators and staff who wish to improve their competency in the field of clinical research management. The modules provide advanced topics, such as IRB (Institutional Review Board) Reliance, Vulnerable Populations, Multicenter Studies and others. The course specifically addresses implications of regulations on performing clinical research activities at UC Davis. The CRC 2.0 modules are offered throughout the year. Each module consists of a didactic material, and a hands-on training/exercise (e.g., mock clinical trial budget analysis and serious adverse event report). Eligible for a CTSC certificate of attendance.
  • CRC 3.0 - Annual Leadership and Professionalism Conference
    Offered once a year this event features presentations from a variety of speakers on topics such as communication skills, professional growth, and team management. Crucial Conversations and Career Pathways in clinical research are examples of such topics. Presentations are followed by a dinner and awards ceremony, where outstanding clinical research staff is recognized for their achievements. Nominations are solicited from departments. Eligible for CTSC certificate of attendance.

Clinical Research Budgeting and Billing Training Program

The regulatory environment related to clinical research billing (CRB) is complex, and compliance with relevant agency guidelines is a key part of every research study. The UC Davis Health CRB training program includes the: 1) ACRP eLearning module ("Managing Billing Compliance Risk: Navigating Medicare in Clinical Trials"), and 2) UC Learning Center course #09155 ("Clinical Research Budgeting and Billing"), which builds on the principles for clinical research billing provided by the ACRP module.

By the end of this program you will be able to:

  • Identify steps of the research billing process
  • Determine what the study team must do to ensure compliance
  • Learn how others support you to ensure research billing compliance

Topics covered in the program:

  • Correctly routing charges for hospital and clinic procedures and services
  • Coverage Analysis in the Bridge
  • EMR Research Study File (RSH) in Epic
  • Association of the patient to the study
  • Association of Orders and Encounters to the study
  • Completion of Billing Review
  • Verification of charges using Reports2Web billing statements 

Questions? Contact Suzan Bruce, PRA IV at skbruce@ucdavis.edu

Mentoring

The CTSC CRC Mentoring Program is a one-on-one mentoring program for UC Davis Clinical Research Coordinators and other research staff in a CRC functional role. Priority is given to those participating in FDA-regulated clinical trials with drugs, devices or dietary supplements. The program is provided for a maximum of 10 hours of face-to-face training with a CTSC mentor. Department funding is required for the trainee to enter the program. A flat fee of $1000 is charged at the entry into the program. This service is initiated upon request from a home department.

Policies and Procedures

Clinical research SOPs (Standard Operating Procedures) are maintained by the CTSC Clinical Trials Office.

Brown Bag Series

Bi-monthly joint SOCRA (Society of Clinical Research Associates)/CTSC brown bags provide an opportunity to learn about new and exciting developments in clinical research around the world. Open to our clinical research colleagues from the Sacramento area and beyond. Attendees may be eligible for a CTSC certificate of attendance and SOCRA CEUs.

Questions? Dannelle Jimenez, Clinical Research Education Program Manager, at dijimenez@ucdavis.edu

UC Davis Clinical Research Guidebook

The UC Davis Clinical Research Guidebook is a compendium of UC Davis processes and administrative procedures available in an online format. The Guidebook follows clinical research process maps and provides step-by-step assistance in an easy-to-follow, at-a-glance format. A supplemental checklist bridges the Guidebook and process maps to serve as a tool for those who wish to track their process through a study.

Laboratory Health and Safety

A list of online training courses is provided by the Laboratory Health and Safety unit for Davis and Sacramento campuses. The Laboratory Health and Safety unit sets standards for research safety management as well as individual laboratory safety programs and activities.