employeehandbook

HOPE CLINIC EMPLOYEE HANDBOOK May 2017

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GETTING TO KNOW US May 2017 The Hope ClinicOur Mission Our VisionThe mission of the Hope Clinic is to conduct human research stud- Our Vision is the im-ies and clinical trials for infectious diseases of public health im- provement of the healthportance; e.g., HIV/AIDS, tuberculosis, seasonal and pandemic in- of our patients and com-fluenza, diarrhea (Clostridium difficile, rotavirus, norovirus), Staphy- munities through infec-lococcus aureus, bioterror agents (anthrax, smallpox, tularemia), tious diseases research,HPV, and others. The clinical studies encompass vaccines, treat- training and education,ments, prevention, community-based research, and laboratory- and service.based translational human immunology. .The Hope Clinic of the Emory Vaccine Center (EVC) is an interna-tional Center of Excellence in clinical and translational research ininfectious diseases vaccines, treatment, and prevention.Who are the team members?http://hopeclinic.emory.edu/about/faculty-staff.htmlMore about us: http://hopeclinic.emory.edu/about/index.htmlThe Hope Clinic of Emory University 500 Irvin Court Suite 200 Decatur, GA 30030 404-712-1370 3

Follow us at: @TheHopeClinicofEmory University Meet one of the first Zika volunteers @HopeClinicEmoryA Glimpse into Our WorldAs part of your orientation it is important to under-stand exactly what we do. There are several articlesthat give insight into the exciting work being done bythe Hope Clinic. Take a few minutes to review thesearticles about the exciting work at Hope Clinic.http://www.hopeclinic.emory.edu/about/news.htmlHope Clinic Operational PracticesNow its time to become familiar with the operation-al side of things.Remember: Hope Clinic is part of Emoryand all Emory University (EU) policies apply.EMORY UNIVERSITY POLICIES http://policies.emory.edu/ 4

Helpful Acronyms Hope Clinic OperationsAKA: Clinic Slang Clinic Hours: 8AM to 5PM. Staff may choose to work 8AM- 5PM with an hour lunch or 8AM to 4:30PM with a 30 minuteCAB–COMMUNITY ADVISORY BOARD lunch. (Any other schedule must be approved by manager. Ap-CFAR-CENTER FOR AIDS RESEARCH proval is subject to clinic needs.) ALL staff are asked to leave theCRID-CLINICAL RESEARCH FOR INFEC- building by 6:30PM and entry on weekends will need manager’s approval.TIOUS DISEASES Dress Code: Business casual is appropriate attire. FridaysCTU-EMORY-CDC HIV/AIDS CLINICAL TRI- are JEAN DAY– jeans must be free of holes or tears.ALS UNIT Emory Network ID: APPENDIX CDMID–DIVISION OF MICROBIOLOGY AND Exam Rooms: Cleaned and stocked weekly by staff team members.INFECTIOUS DISEASES Hope Clinic Calendar: You must request access to the cal-EML-EMORY MEDICAL LABS endar from the Sr. Associate Director Programs. The calendar isEIDCRL-EMORY INFECTIOUS DISEASES used for scheduling staff and participant visits. You will not be able to make changes to the calendar, unless you have beenCLINICAL RESEARCH LAB granted access to edit.ERMS-EMORY RESEARCH MANGEMENT Housekeeping: M/W/F-please set trash outside of office.SYSTEMEVC-EMORY VACCINE CENTER ID Badge: click hereHPTN-HIV PREVENTION TRIALS NETWORKHVTN-HIV VACCINE TRIALS NETWORK Information Technology Support: You may email your re-OCR-OFFICE OF CLINICAL RESEARCH quests to [email protected] or call 7-7777. IT supportOSP-OFFICE OF SPONSORED PROGRAMS also provides onsite support (approximately every 2 weeks).VRC-VACCINE RESEARCH CENTERVTEU-VACCINE AND TREATMENT EVALUA- Lunch/Breaks: Will be taken according to clinic/team sched- ule. Please indicate your departure and return times, usually onTION UNIT office door. This ensures that staff is notified. Kitchen/Refrigerator: The break room is cleaned monthly by staff volunteers. Security/Keys: Obtain keys to building and office from Sr. Associate Director Programs. Staff Meetings: General Hope Clinic meetings are held every Wednesday afternoon. Clinical Staff meetings are bi-weekly (also on Wednesday afternoon). Supplies: Staff submit order requests on Tuesdays Telephone: APPENDIX A. Training: Use the link provided to access training required for all Emory employees involved with clinical research. You will be provided a list of all additional required training that is specific to your position. 5

Day 1: Itinerary Introduction to staff Tour of facilities Review staff roles and job responsibilities Receive key and alarm code Phone/Calendar/Printer Access Review Standard Operating Pro- cedures Sign Confidentiality Agreement Meet VTEU Lead Coordinator Meet HVTN Lead Coordinator Meet QA/QI Manager Meet Regulatory Team Meet Finance Team Meet Principal Investigators (PIs)After receiving a tour of the facilities, you will then meet to discuss your re-sponsibilities and review your job description. From there, you will meet withthe Operations manager to review Standard Operating Procedures and tosign the Confidentiality Agreement.You will also meet with other staff members to get information about VTEU,HVTN, Quality Assurance and Regulatory Affairs.You will also receive an orientation email from Emory. Follow the link andcomplete as instructed. 6

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Course Course Link for TrainingHIPPA in a Hurry 210001 https://elmprod.emory.edu/HIPPA and Research 210002 https://elmprod.emory.edu/HIPPA Security 210003 https://elmprod.emory.edu/ www.citiprogram.orgCITI Human Subjects ProtectionCITI Good Clinical Practice (GCP) and www.citiprogram.orgICH www.citiprogram.orgCITI Biomedical Focus www.citiprogram.org You must enroll online at:CITI Clinical Research Coordinator https://elmprod.emory.edu/2-Day Classroom Introduction into 205037Clinical Research (if clinical re-search experience less than 5 yrs)Blood Borne Pathogens (BBP) for 240100 http://www.ehso.emory.edu/training/Research 240120 courses.html 240150Biosafety http://www.ehso.emory.edu/training/Research Laboratory Safety 205034 courses.htmlConflict of Interest (COI) 205033ERMS Training http://www.ehso.emory.edu/training/ courses.htmlAHA Basic Life Support (CPR) https://www.ecoi.emory.edu/ You must enroll online at: 8 https://elmprod.emory.edu. https://elmprod.emory.edu/

 All training courses must be completed within 30 days. Additional training for your assigned studies will be given to you. Training certifications expire and must be renewed as required. 9

Training Documentation for Regulatory What do I need to give to Regulatory? Basic Requirements: CV—dated and signed in center of page, with your Hope Clinic Ti- tle on it. You also need a revision date. Biomedical CITI Certificate Good Clinical Practice CITI Certificate Official Start Date Confidentiality Policy Hepatitis B Declination Form Coordinator Training: Emory ID Number EHSO Research Lab Safety Certificate EHSO Blood borne Pathogens Training Certificate Biosafety Training Certificate HIPAA and Research Certificate HIPAA Security Certificate HIPAA in a Hurry Certificate Introduction to Clinical Research at Emory Sponsor/Network Trainings: This is dependent upon which network you will be working with. 10

 Additionally, please give your name, credentials, position title, email and office phone number to website manager,. Complete the photo release form (Appendix D) and send it to the website manager May 2017

Emory University QUICK LINKS:Human ResourcesTime Off & HolidaysBenefitsLGTB LifeNew Hires 12

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APPENDIX A: 14

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APPENDIX B: 18

APPENDIX C:May 2017

APPENDIX D: May 2017