Clinical Research Staff Handbook Checklist Employee Name: Hire Date: Goal Date: Supervisor Name: 1 - Administrative Tasks Security and Access Obtain PennCard Obtain PennKey Obtain Hospital Identification Badge (ID) (see Supervisor) Obtain Medical School Perimeter Black Key – Penn only Establish Email Account Obtain Telephone #/Voicemail/page/cell Obtain access to Departmental Shared Drive Department Specific Items Online maps (UPENN/SCOM and UPHS) 2 - Mandatory Access and Training Knowledgelink Penn Profiler CITI - Protection of Human Subjects HIPAA - Entity Specific UPHS - Annual Mandatory Education (AME) University Orientation/UPHS Orientation Perelman School of Med Orientation (PSoM only) Penn CRC Certification: Clinical Research Staff Portal and Registry Clinical Research Foundations Course Human Subjects ERA (HS-ERA) Grant Management (Penn ERA) UPHS Electronic Systems: Epic EMR and/or APM SunRise OnBase (formally EWebhealth ChartOne) MedView Other Electronic Access 3 - Additional Access and Training Nurse Practitioners, Physician assistants, RNs, LPNs, Medical Assistants Environmental Health & Radiation Safety (EHRS) Phlebotomy Training Human Subjects Research Workshops Software/Computer Training (Excel, Word, Outlook, Power Point) Professional Research Associations (i.e. SoCRA, ACRP) Clinical Research Staff Handbook Checklist Version Date: 9/16/ 2013 Handbook Page # Date Completed Reviewed By Comments Date Completed Reviewed By Comments Date Completed Reviewed By Comments 4 4 4 5 5 5 6 6 6 Handbook Page # 6 7 7 7 8 8 8 8 8 9 10 10 10 11 11 11 12 Handbook Page # 12 12 12 13 13 13 1 of 2 Clinical Research Staff Handbook Checklist Employee Name: 4 - Society of Clinical Research Coordination and Management (SCRCM) Overview 5 - Self Study Research Training: Research Ethics, Regulations & GCP Overview Belmont Report ICH E6: Guideline for Good Clinical Practice Research Regulations: Federally Funded Human Research: 45 CFR 46 Regulations Drug & Device Research: 21 CFR 6 - Research Administration Overview The Institutional Review Board (IRB) Conflict of Interest Standing Committee (CISC) Office of Research Services (ORS) Center for Technology Transfer (CTT) Environmental Health & Radiation Safety (EHRS) Institutional Bio-Safety Committee (IBC) Radiation Research Safety Committee (RRSC) Radioactive Drug Research Committee (RDRC) 7 - Penn Medicine Offices Overview Office of Research Support Services (ORSS) Office of Clinical Research (OCR) Clinical & Translational Research Center (CTRC) Investigational Drug Services (IDS) Radiology Regulatory & Technology Committees CAMRIS (MRI research) CACTIS (CT research) PET Center Committee Abramson Cancer Center Cancer Center Clinical Trials Scientific Review (CTSRMC) Data and Safety Monitoring Committee (DSMC) Pathology & Laboratory Medicine Research Support Services (P&LM) Hospital Perioperative Services 8 - Contacts Overview Supervisor Signature Clinical Research Staff Handbook Checklist Version Date: 12/7/15 Handbook Page # 13 Handbook Page # 14 14 14 Date Completed Reviewed By Comments Date Completed Reviewed By Comments Date Completed Reviewed By Comments Date Completed Reviewed By Comments Date Completed Reviewed By Comments 15 15 Handbook Page # 15 16 16 16 17 17 17 17 18 Handbook Page # 19 19 19 20 20 20 20 21 21 21 21 21 22 22 Handbook Page # 23 Date 2 of 2