Training for Clinical Research Coordinators

Attention new CRCs!! Please join us for Bootcamp, which includes Orientation, CRC 101: Informed Consent,  and CRC 102: IRB & Safety Reporting. The courses are focused on basic knowledge that is beneficial for new staff as they start their clinical research career at UCSF. The target audience is new UCSF employees, but anyone who would like a refresher is welcome to participate.

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We highly recommend that new CRCs commit to attending both mornings for completion of all courses.

Class schedule:

• Orientation -  online, on-demand (must be completed before class on 2/5); details and a link to the course will be sent upon registration
• CRC 101: Informed Consent - in-person; Wednesday, February 5th from 8:30am - noon
• CRC 102: IRB & Safety Reporting - in-person; Thursday, February 6th from 8:30am - noon

NOTE:  you must use your UCSF email address to register; registering for Bootcamp enrolls you in Orientation, CRC 101, and CRC 102 - please do NOT also enroll in the courses individually.

This workshop is the beginning class in the series. It reviews the basic components of the CRC role at UCSF. The first section focuses on the CRC responsibilities, common tasks, and how CRCs will work with UCSF partners in their day-to-day roles. The session also introduces resources such as the HUB and IRB website. The second section explores job basics including Best Practices for Documentation, Data Security, IRB, Coverage Analysis and the concept of Study Start Up.

Audience: New CRCs under 6 months.
Prerequisites: Review the HUB including Suggested Training List, HIPAA 101 and Human Subjects via CITI.

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NOTE: there is no need to register for individual courses if you have registered for Bootcamp

Informed Consent is a critical part of the CRC role. In this interactive class we will demonstrate and practice performing an informed consent. Additional topics include the Informed Consent Process and Documentation.

Audience: New and current CRCs.
Prerequisites: HIPAA 101, Human Subjects and GCP via CITI, and Research Integrity Video

Please come ready to participate! Remember to bring your own study consents for practice (or we will provide if you don’t have one).

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NOTE: please do NOT register for individual courses if you have registered for Bootcamp; you must use your UCSF email to register

This class will review Adverse Event (AE) recording best practices, including a demonstration of a participant interview with break-out time for all to practice. The class will also discuss IRB reporting requirements including the following: AE/SAE Reporting, Post Approval Reporting and Subject Injury.

Audience: New and current CRCs.
Prerequisites: Human Subjects and GCP via CITI.

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NOTE: there is no need to register for individual courses if you have registered for Bootcamp; you must use your UCSF email to register

The pre-award section of this class covers study start-up and finance topics important to CRCs conducting interventional research studies using APeX and OnCore for billing procedures. The post-award section covers ZZ statements and research billing with a focus on coverage analysis and its impacts on the research process.

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Audience: New or current CRCs with responsibilities on interventional studies.
Prerequisites: Review the Start-Up Diagram and the APeX Job Aid on the HUB.

Effective Communications are an essential component of protecting participant privacy, confidentiality, and for developing positive relationships with your participants, supervisor, colleagues and University-wide. In this course we will discuss best practices for communicating with your participants, supervisors and partners at UCSF.

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Audience: New or current CRCs.
Prerequisites: none

This course will describe how to identify if your study requires an IND, types of INDs, and the scope of the application process. It will also discuss how to handle IND modifications, safety reports and annual reports.

Audience: New or current CRCs with responsibilities on Interventional Studies.
Prerequisites: none.

This course will describe the origin, flow and management of data through a clinical study, and the specific role of the CRC in each phase of the process from data design to analysis & reporting. The course will highlight best practices for data design, management and analysis as well as how to implement processes for quality assurance and quality control. This course will summarize resources available at UCSF.

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Audience: Current CRCs
Prerequisites: none

This course focuses on the purpose and process for monitoring and audits in clinical research. We will describe best practices and provide checklists and activities to help you prepare in the event of an audit. The target audience is advanced CRCs that have completed studies involving auditing, or those who may experience auditing activities.

Audience: CRCs with some study experience.
Prerequisites: CRC Bootcamp (Orientation, CRC 101: Informed Consent, CRC 102 IRB & Safety Reporting) is highly recommended.

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Protocol Training, MOPs & SOPs is an advanced series course that reviews protocol training fundamentals, manual of procedure (MOP) & standard operating procedure (SOP) functions and best practices for creation and maintenance thereof. This course is especially applicable for those working on NIH-sponsored Investigator-initiated clinical trials or studies where UCSF is the coordinating center.

Audience: Experienced CRCs who have been in their role for at least 1 year.
Prerequisites: CRC Bootcamp Series (recommended)

• Sign up for an OnCore account
• Get help with the new processes for Track More with OnCore

1. CRC Suggested Training Checklist
2. List of Acronyms
3. APeX Job Aid
4. Study Start-Up Diagram (Industry)
5. Study Start-Up Checklist
6. Note to File