Suggested Training for Clinical Research Coordinators

The Clinical Trials Operations (CTO) Training team conducts regular, in-person training courses for Clinical Research Professionals of all levels. In particular, new CRCs, are strongly encouraged to sign up for C TO Foundations, which are courses focused on basic knowledge beneficial for new staff as they start their clinical research career at UCSF. Please visit the CTO Training webpage for course information and schedules. Register via the UC Learning Center.

Please review the Suggested Training Checklist created for CRCs, PIs and other research support staff at UCSF, both for onboarding and ongoing training. The checklist includes various training materials currently available, recommended and as needed items for each type of research (behavioral, observational and interventional). The specific trainings that you require will vary based on what types of clinical research projects you are working on. While this general list is a good starting place, we recommend that you speak to your Division/Department administrator, Principal Investigator and/or supervisor to see which topics are most important.

This educational resource is designed for both new and experienced CRCs, and other clinical research staff at UCSF who are seeking training resources, including written material, classes and computer based learning modules.

CRCs are responsible for the organization, coordination, and overall integrity of a research project with humans. Principal and co-investigators provide the overall direction in a clinical study, but CRCs have significant roles in clinical study activities, including Clinical Trial Study Start-Up.

Please review the recently posted Clinical Research Coordinator (CRC) Job Series.

**Course Descriptions and Training Checklist**
Principles of Good Clinical Practice (GCP) Overview of the regulations that guide human subject research and what are those responsibilities. Study Start Up Best practice considerations when opening a new study to avoid management problems Recruitment Review of FDA and IRB guidance on recruiting subjects for research. Consenting Part 1 - Overview of Belmont report Part 2 - Methods for consent compliance when enrolling subjects Documentation Discuss paper and electronic copies and the importance of investigator and coordinator documentation effecting audit outcomes Safety of the Subject – Definitions Defining the terminology needed for Adverse event documentation Reporting Adverse Events Overview of timeliness for reporting and which agencies are involved. Sponsor Responsibilities Describes how sponsor monitoring is regulated for quality control and quality assurance of both investigative sites whether industry or sponsor- investigator studies Preparing for an Audit Steps to prepare for and participate in external audits and what comprises audit readiness Tools and Guidance Acronym List HUB Course Description Checklist Study Closeout Checklist Sample CRC SOP No-Cost SoCRA Recertification Resources for New UCSF Coordinators HRPP Training Opportunities Association of Clinical Research Professionals Society of Clinical Research Associates (SoCra) Interactive Training Video (The Research Clinic)

**Human Research Protection Training**
Human Research Protection Training Note: These modules can take several days to complete.

**Good Clinical Practice (GCP) Basics**
Good Clinical Practice (GCP) Information The CITI Good Clinical Practice (GCP) Basic Course is an overview of GCP. Some units on campus require this course, but it is optional for the HRPP. Be sure to check with your departmental GCP training requirements.

**iRIS**
iRIS IRB’s online submission and review system for research studies. The system also functions as a document repository, providing study personnel with easy access to study documents like approved consent forms.

**Clinical Research Coordinator Council and Listserv**
Clinical Research Coordinator Council If you are interested in participating in a Professional Development and Best Practices Group for Clinical Research Coordinators, please find more information here. All CRCs and any clinical research support staff are encouraged to join the CRC’s listserv.

**APeX**
APeX training for Clinical Coordinators These modules take about 5 hours according to the APEX training staff.

**Data Management Tools**
Data Management Tools available online include RedCap, MyResearch, & Research Data Browser. REDCap is a secure, web-based application for building and managing online surveys and databases. To receive access, complete the MyResearch Add New Users Request Form. For training information please contact Kimberly Romero or call 415-476-5768

We recommend that Coordinators who are new to UCSF visit Resources for New Coordinators for general institutional information.