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Training for Clinical Research Coordinators</h1> <div class="content-top"> </div> <div id="main-wrapper"> <div id="main" class="clearfix"> <div id="content" class="column"> <div class="inside"> <a id="main-content"></a> <div class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-1306" class="node node-page slider-secondary clearfix" about="/research-coordinator" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Suggested Training for Clinical Research Coordinators" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-last-revised field-type-datetime field-label-inline inline"><div class="field-label">Last revised<span class="colon">:</span> </div><div class="field-items"><div class="field-item even"><span property="dc:date" datatype="xsd:dateTime" content="2024-04-15T00:00:00-07:00" class="date-display-single">04/15/2024</span></div></div></div><div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><p>The Clinical Trials Operations (CTO) Training team conducts regular, in-person training courses for Clinical Research Coordinators (CRCs) of all levels. In particular, new CRCs are strongly encouraged to sign up for <a href="https://crs.ucsf.edu/crc-training#CRC-Bootcamp-Orientation-CRC-101-CRC-102---------------Thursday-and-Friday-November-12th-and-13th">C</a><a href="https://ctsi.ucsf.edu/programs/clinical-trials-operations/training">TO Foundations</a>, which are courses focused on basic knowledge beneficial for new staff as they start their clinical research career at UCSF. Please visit the <a href="https://ctsi.ucsf.edu/programs/clinical-trials-operations/training">CTO Training webpage</a> for course information and schedules. Register via the <a href="https://learning.ucsf.edu/">UC Learning Center</a>.</p> <p>Please review the <a href="https://ctsi.ucsf.edu/sites/g/files/tkssra3501/f/wysiwyg/Suggested%20Training%20Checklist%2029Nov2023.pdf" target="_blank">Suggested Training for Clinical Research</a> 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.</p> <p>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. </p> <p>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 <a href="https://ucsf.box.com/s/fpg8fggvuzqaogw45kfvny2cpdr7k4k7" target="_blank">Clinical Trial Study Start-Up</a>.</p> <p>Please review the recently posted<strong> </strong><a href="https://srs.ucsf.edu/hr.php/x/files?F=1&cms_id=335">Clinical Research Coordinator (CRC) Job Series</a>.</p> <table border="0" cellpadding="1" cellspacing="1" class="collapsible collapsed"> <caption><strong><a id="Course Descriptions" name="Course Descriptions"></a>Course Descriptions and Training Checklist</strong></caption> <tbody> <tr> <td> <ol> <li> <p><strong><a href="/sites/g/files/tkssra261/f/1.CRCRole_GCP and Ethical Principles.pdf">Principles of Good Clinical Practice (GCP)</a></strong><br /> Overview of the regulations that guide human subject research and what are those responsibilities.</p> </li> <li> <p><strong><a href="/sites/g/files/tkssra261/f/2.CRCRole_Study Start up.pdf">Study Start Up</a></strong><br /> Best practice considerations when opening a new study to avoid management problems</p> </li> <li> <p><strong><a href="/sites/g/files/tkssra261/f/3.CRCRole_Recruitment.pdf">Recruitment</a></strong><br /> Review of FDA and IRB guidance on recruiting subjects for research.</p> </li> <li> <p><strong>Consenting</strong><br /> <a href="/sites/g/files/tkssra261/f/4a.CRCRole_Consent-part 1.pdf">Part 1 - Overview of Belmont report</a><br /> <a href="/sites/g/files/tkssra261/f/4b.Consent-part 2.pdf">Part 2 - Methods for consent compliance when enrolling subjects</a></p> </li> <li> <p><a href="/sites/g/files/tkssra261/f/5.CRCRole_Documentation.pdf"><strong>Documentation</strong></a><br /> Discuss paper and electronic copies and the importance of investigator and coordinator documentation effecting audit outcomes</p> </li> <li> <p><a href="/sites/g/files/tkssra261/f/6. Adverse Eventsd Definitions.pdf"><strong>Safety of the Subject – Definitions</strong></a><br /> Defining the terminology needed for Adverse event documentation</p> </li> <li> <p><a href="/sites/g/files/tkssra261/f/7. Reporting Adverse Events.pdf"><strong>Reporting Adverse Events</strong></a><br /> Overview of timeliness for reporting and which agencies are involved.</p> </li> <li> <p><a href="/sites/g/files/tkssra261/f/8.CRCRole_21CFR 312.pdf"><strong>Sponsor Responsiblities</strong></a><br /> Describes how sponsor monitoring is regulated for quality control and quality assurance of both investigative sites whether industry or sponsor- investigator studies</p> </li> <li> <p><a href="/sites/g/files/tkssra261/f/9.CRCRole_FDA INSPECTIONS.pdf"><strong>Preparing for an Audit</strong></a><br /> Steps to prepare for and participate in external audits and what comprises audit readiness</p> </li> </ol> <p><strong>Tools and Guidance</strong></p> <ul> <li><a href="https://hub.ucsf.edu/sites/g/files/tkssra261/f/Acronym%20List%2019jan23.pdf" target="_blank">Acronym List</a></li> <li><a href="/sites/g/files/tkssra261/f/New_Coordinator_Training_Checklist.pdf">HUB Course Description Checklist</a></li> <li><a href="https://ucsf.box.com/s/1go9xieab9t5z2as04dtej0b5s90uhin">Study Closeout Checklist</a></li> <li><a href="/sites/g/files/tkssra261/f/Sample_SOP_CRC JAN2014.doc">Sample CRC SOP</a></li> <li><a href="/sites/g/files/tkssra261/f/No-Cost SoCRA recert.pdf">No-Cost SoCRA Recertification</a></li> <li><a href="/new-coordinators">Resources for New UCSF Coordinators</a></li> <li><a href="http://irb.ucsf.edu/training">HRPP Training Opportunities</a></li> <li><a href="http://www.acrpnet.org/">Association of Clinical Research Professionals</a></li> <li><a href="http://www.socra.org/">Society of Clinical Research Associates (SoCra)</a></li> <li><a href="http://ori.hhs.gov/TheResearchClinic">Interactive Training Video (The Research Clinic)</a></li> </ul> </td> </tr> </tbody> </table> <table border="0" cellpadding="1" cellspacing="1" class="collapsible collapsed"> <caption><strong>Human Research Protection Training</strong></caption> <tbody> <tr> <td> <p><a href="/human-subjects">Human Research Protection Training </a><br /> Note: These modules can take several days to complete.</p> </td> </tr> </tbody> </table> <table border="0" cellpadding="1" cellspacing="1" class="collapsible collapsed"> <caption><strong>Good Clinical Practice (GCP) Basics</strong></caption> <tbody> <tr> <td> <p><a href="/good-clinical-practice">Good Clinical Practice (GCP) Information </a><br /> 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.</p> </td> </tr> </tbody> </table> <table border="0" cellpadding="1" cellspacing="1" class="collapsible collapsed"> <caption><strong>iRIS</strong></caption> <tbody> <tr> <td> <p><a href="/imedris-training">iRIS</a><br /> 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.</p> </td> </tr> </tbody> </table> <table border="0" cellpadding="1" cellspacing="1" class="collapsible collapsed"> <caption><strong>Clinical Research Coordinator Council and Listserv</strong></caption> <tbody> <tr> <td> <p><a href="http://irb.ucsf.edu/clinical-research-coordinators-council">Clinical Research Coordinator Council</a><br /> If you are interested in participating in a Professional Development and Best Practices Group for Clinical Research Coordinators, please find more information <a href="http://irb.ucsf.edu/clinical-research-coordinators-council">here</a>.</p> <p>All CRCs and any clinical research support staff are encourged to join the <a href="http://irb.ucsf.edu/clinical-research-coordinators-council#listserv">CRC’s listserv</a>.</p> </td> </tr> </tbody> </table> <table border="0" cellpadding="1" cellspacing="1" class="collapsible collapsed"> <caption><strong>APeX</strong></caption> <tbody> <tr> <td> <p><a href="http://myapex.ucsf.edu/" id="APEX" name="APEX"> </a><a href="/apex-stor-ucare">APeX training for Clinical Coordinators</a><br /> These modules take about 5 hours according to the APEX training staff. </p> </td> </tr> </tbody> </table> <table border="0" cellpadding="1" cellspacing="1" class="collapsible collapsed"> <caption><strong>Data Management Tools</strong></caption> <tbody> <tr> <td><a href="/data-management">Data Management Tools</a> available online include RedCap, MyResearch, & Research Data Browser. <a href="http://redcap.ucsf.edu">REDCap</a> is a secure, web-based application for building and managing online surveys and databases. To receive access, complete the <a href="https://myresearch.ucsf.edu/myresearch">MyResearch Add New Users Request Form</a>. For training information please contact Kimberly Romero or call 415-476-5768</td> </tr> </tbody> </table> <p>We recommend that Coordinators who are new to UCSF visit <a href="/new-coordinators">Resources for New Coordinators</a> for general institutional information. </p> </div></div></div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-menu-block-2" class="block block-menu-block"> <h3><a href="/training" class="active-trail">Training</a></h3> <div class="content"> <div class="menu-block-wrapper menu-block-2 menu-name-main-menu parent-mlid-0 menu-level-2"> <ul class="menu"><li class="first leaf menu-mlid-2156"><a href="/apex-stor-ucare">APeX / STOR & other</a></li> <li class="expanded active-trail active menu-mlid-2211"><a href="/research-coordinator" class="active-trail active">Clinical Research Coordinators</a><ul class="menu"><li class="first last leaf menu-mlid-2401"><a href="/new-coordinators">Resources for New Coordinators</a></li> </ul></li> <li class="leaf menu-mlid-2431"><a href="/human-subjects">Human Subjects</a></li> <li class="leaf menu-mlid-2376"><a href="/imedris-training">iRIS / IRB Submissions</a></li> <li class="leaf menu-mlid-2476"><a href="/investigator-education">Investigator Education</a></li> <li class="leaf menu-mlid-22256"><a href="/oncore">OnCore</a></li> <li class="leaf menu-mlid-2466"><a href="/safety">Safety Courses</a></li> <li class="last leaf menu-mlid-2596"><a href="/glossaries">Glossaries</a></li> </ul></div> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="region region-footer"> <div id="block-block-6" class="block block-block"> <div class="content"> <style type="text/css"> <![CDATA[/* ><!]]>*/ </style> <div class="quickref"> <h2 style="color:#000;font-size:22px;margin:0;padding: 0 0 6px;">Quick Reference</h2> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first"> <ul> <li><a href="http://policies.ucsf.edu/" target="_blank">Campus Policies</a></li> <li><a href="http://cancer.ucsf.edu/" target="_blank">Cancer Center (HDFCCC)</a></li> <li><a href="http://accelerate.ucsf.edu/research/crs" target="_blank">Clinical Research Services</a></li> <li><a href="http://ctsi.ucsf.edu" target="_blank">Clinical & Translational Science Institute (CTSI)</a></li> </ul> </div> <div class="wysiwyg_threecols--second"> <ul> <li><a href="http://coi.ucsf.edu/" target="_blank">Conflicts of Interest (COI)</a></li> <li><a href="http://accelerate.ucsf.edu/consult" target="_blank">Consultation Services</a></li> <li><a href="http://accelerate.ucsf.edu/cores/" target="_blank">Cores Search</a></li> <li><a href="https://ehs.ucsf.edu/" target="_blank">Environment, Health and Safety</a></li> <li><a href="http://compliance.ucsf.edu/" target="_blank">Ethics & Compliance</a></li> </ul> </div> <div class="wysiwyg_threecols--third"> <ul> <li><a href="http://globalhealthsciences.ucsf.edu/" target="_blank">Global Health Sciences</a></li> <li><a href="http://ita.ucsf.edu/" target="_blank">Innovation, Technology & Alliances</a></li> <li><a href="http://irb.ucsf.edu" target="_blank">IRB / Human Research Protection Program</a></li> <li><a href="https://osr.ucsf.edu/" target="_blank">Office of Sponsored Research</a></li> <li><a href="http://profiles.ucsf.edu" target="_blank">UCSF Profiles</a></li> </ul> </div> </div> </div> <p style="float: right; margin: 1.2em 30px -1.5em; text-align: right; width: 6em;"><a href="/cdn-cgi/l/email-protection#e3abb6a1a396809085cd868796" style="color:#FFF"><span class="__cf_email__" data-cfemail="efa7baadaf9a8c9c89c18a8b9a">[email protected]</span></a></p> </div> </div> </div> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#99d1ccdbd9ecfaeaffb7fcfdec">Contact Us</a></li> <li><a href="https://www.ucsf.edu/accessibility-resources">Accessibility</a></li> <li><a href="https://www.ucsf.edu/website-privacy-policy">Privacy Policy</a></li> <li><a href="https://websites.ucsf.edu/website-terms-use">Terms of Use </a></li> <li><a href="https://websites.ucsf.edu/azlist">A-Z Website List</a></li> </ul> </nav> <div class="footer--copyright"> <p>© 2024 The Regents of the University of California</p> </div> </div> </div> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="text/javascript"> /*<![CDATA[*/ (function() { var sz = document.createElement('script'); sz.type = 'text/javascript'; sz.async = true; sz.src = '//siteimproveanalytics.com/js/siteanalyze_8343.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(sz, s); })(); /*]]>*/ </script> </body> </html>