Clinical Research Coordinators The Research Navigator was created specifically to assist Research Teams in navigating through the entire study cycle, from IRB application to study close-out. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Clinical Research Coordinator is typically considered the "heart" of the clinical trial - an integral part of the research team. As such, the Office of Human Research Affairs is committed in our efforts to support our CRCs with the resources you need to ensure that your study is being conducted in compliance with the study protocol as well as the federal, state, and institutional guidelines and regulations applicable to the study. OHRA, in partnership with the Office of Clinical Trials (OCT), promotes CRC efforts by helping to develop educational programs and establish a coordinator network to provide you with a community with whom you can share your experiences and pick up some tips to make your day run a little smoother. We view education as ongoing and dynamic, but we also know that everyone needs initial training to get them started. All new CRCs must complete the required trainings listed below within the timeline set by their supervisors to ensure compliance with institutional policies and regulatory requirements. New Clinical Research Coordinator Training Checklist Required Training Where to Find It New Hire Orientation (MMC-Einstein) Human Resources Montefiore associates: eLearning assigned by manager - New Associate Orientation (NAO) #6560 Einstein associates: Discuss with hiring manager HIPAA training (for Einstein associates only) Montefiore eLearning - Self assign Course "HIPAA Refresher Training" #1135001 Clinical Research Coordinator (CRC) Foundations www.citiprogram.org Register for the CRC Foundations course and the CRC Advanced course Guidelines for Conduct of Clinical Research at Montefiore Einstein Clinical Research Guidelines Good Clinical Practice (GCP)* www.citiprogram.org Register for initial GCP course or refresher Human Subjects Research (HSR)* www.citiprogram.org Register for HSR course Departmental Research Training (Policies and SOPs) Department Manager or Administrator Comprehensive Epic/Velos Research Training Submit an IT Self-Service Portal Ticket Review training schedule prior to issuing ticket Epic Media Training for scanning consents and other research documents Montefiore eLearning - Self assign Course: EPIC - REQ - Scanning #499001 iRIS Training (Einstein IRB application system) System Guidance available; or contact iris-support@einsteinmed.org IRB Manager Training (BRANY IRB system) BRANY IRB Services info@BRANY.com or 516-470-6900 BRANY SMART (CTMS) Training Oncology studies: Jill Filipelli (jfilipelli@brany.com) non-Oncology studies: Eileen Summers (esummers@brany.com) Greenphire ClinCard Subject Reimbursement System Training Montefiore studies: Carmen Rodriguez, Greenphire Administrator (carmrod@montefiore.org) Einstein studies: Celia D'Armetta-Hughes, Assistant Director Finance (cdarmettah@montefiore.org) As Applicable Training Where to Find It Regulated Biological Material (hazardous goods) Training* www.citiprogram.org Register for the CITI - Shipping and Transport of Regulated Biological Materials course, which meets the IATA and DOT requirements Laboratory Safety Training for associates who collect and process biological samples (including centrifugation, aliquotation, freezing, pipetting, etc.) Montefiore eLearning - Self assign Course: Biosafety #606001 Protocol Training Conducted by Study Sponsor Acuvia eRegulatory Binder System Training Carmen Rodriguez, OCT, Acuvia Administrator (carmrod@montefiore.org) Electronic Data Capture (EDC) Training Conducted by Study Sponsor Montefiore Einstein teams can use REDCap for Investigator-Initiated projects Cayuse - grant submission portal Regina Janicki (regina.janicki@einsteinmed.org) or Chanonjoy C. Saha (dhanonjoy@saha@einsteinmed.org) ATLAS - defining and exporting health system data for cohort assessment Training manual if you need help: atlas-help@montefiore.org *CITI Profiles must list Albert Einstein College of Medicine as the affiliated Institution. All CITI courses noted above are free of charge. Please refer to the OHRA CITI Training Support Page for instructions on how to access your courses and obtain a copy of your training certification for your files. Compliance: Organizing Study Records A key component of a Clinical Research Coordinator’s job is to maintain accurate and up-to-date study records. Study binders are your protection against non-compliance and potential harm. The documents below have been prepared for you by the Montefiore Einstein Research Compliance Group, who is available to answer any research compliance questions you might have (e.g., how to set up and maintain your regulatory or subject binder, recording/reporting protocol deviations or clinical adverse events, etc.). Regulatory Binder Required Document Checklist Enrollment Log Template Note to File Template Delegation of Authority and Signature Log Template Training Log Template Specimen Tracking Log Template Subject Binder Required Document Checklist Informed Consent Note Template Inclusion Exclusion Checklist Template Adverse Event Log Protocol Deviation Log Template Audit Preparation Research is subject to audit and inspection by regulatory agencies, including the Food and Drug Administration ("FDA") and Office for Human Research Protections ("OHRP"). Here are some materials to familiarize you with what an audit might entail. Einstein IRB Audit and Inspection Guidelines FDA Inspection of Clinical Investigators Information Sheet FDA Bioresearch Monitoring (BIMO) Checklist Commercial Certification and Education Society of Clinical Research Associates (SoCRA) Association of Clinical Research Professionals Comparison of SoCRA and ACRP Certification Barnett Educational Services