CAMPUS RESOURCES Click on Topic Areas Below for Detailed Content Career Development 101 for Early-Career Investigators August 15, 2016 Topic Presenter Welcome & Agenda Gretchen Caughman, PhD Executive Vice President & Provost Office of the Provost “Research at AU” Michael Diamond, MD Senior Vice President for Research, Academic Affairs Associate Dean, Medical College of Georgia Chair and Brooks Professor, Department of Obstetrics & Gynecology Institutional Review Board (IRB) Heather Wilson, CIM Regulatory Compliance Manager Augusta University IRB Office Grants & Contracts Sarah White, MED Associate Vice President, Research Administration Sponsored Program Administration Clinical Trials Office Mary Anne Park, MSN, RN, CCRC Associate Clinical Professor of Surgery & Neurology Manager, Clinical Trials Office BREAK/ Information Tables Visit Tables Library Resources Gail Kouame, MLIS Chair, Research and Education Services Media Resources Karla Leeper, PhD Executive Vice President, Strategic Communications & Chief Marketing Officer Human Resources (HR) Laurie Bush Manager, Faculty Support Services International and Postdoctoral Services Office (IPSO) L.D. Newman, JD Assistant Vice President of International Initiatives BREAK/ Information Tables Visit Tables Augusta University Faculty Development Deborah Richardson, PhD Director, Faculty Development, Academic and Faculty Affairs Teaching/ Educational Innovation Institute (EII) Ralph Gillies, PhD Associate Dean, Education Discovery Institute Promotion & Tenure (P&T) Michelle Mims Faculty Support Liaison, MCG Dean’s Office WORKING LUNCH: Networking, Mentoring Caryl Hess, PhD, MBA Director, Leadership Development; Office of Leadership Development Nita Maihle, PhD Associate Director of Education Georgia Cancer Center, Dean, Ovarian Cancer Academy Closing Lisa Middleton, PhD Director, Office of Education and Internal Communications Georgia Cancer Center
Initiating Research• Augusta University has a tripartite mission of Service,
Education and Research.• TheOfficeofSeniorVicePresidentforResearchsupportsresearchbyprovidingtraining,education,grants,infrastructureintheformofITSystems,Researchlocations,andCollaborativeOpportunitiesforresearch
Research Education & TrainingTrainingfornavigatingresearchProcessesareprovidedvia:
• Each of the Steps Identified in the Flow Chart are TRACKED in the OnCore Checklists
• Users / PI are responsible for entering dates of actions
• Offices/ Departments are responsible for entering the date of their actions
• Progress for all Pipeline studies is reviewed weekly any issues or questions can be brought to management’s attention for review and discussion at weekly meeting
• Please email [email protected] for any studies you would like reviewed at the weekly meeting
Enter Protocol CALENDAR, BUDGET, and develop electronic Case Report
Forms as applicable
Upon Entry of study into Task Management
DSPA collates and reviews budget details and verifies approvals (IRB, Ancillary, Budget, COI/Financial Disclosures)
ConflictofInterest
Declarations are submitted to Conflict of
interest Panel
COI Panel reviews and provides
recommendation to IRB Committee
IRBSubmission
Is this an Investigator
Initiated Trial?
YESNO
InternalIRB
Process
ExternalIRB
Process
Clinical Trial protocol is submitted to IRB Committee(External & Internal) for review.
AU IRB Office issues IRB Committee Approval Letter to PI.
Training&
Education
Completed Training Records
are Submitted
AdditionalApprovals
(asapplicable)
Radiation Safety
Data Management
& Storage
*Chemical Safety
MedicationManagement
Research Pharmacy Process
Non-Research Pharmacy Process
Is this Clinical Trial conducted at a
AUHealth location?
YES NO
Budget&Finances
*BudgetPreparation
andNegotiation
eSProute
AU Health Approval
Final Budget is agreed upon and approved by Internal Resources and
sponsors
Negotiated Budget Details are included in the Clinical
Trial Agreement
CONCURRENT RESEARCH INITIATION PROCESSES
Agreements(asapplicable)
DSPA ACTIVATES ACCOUNT
All Agreements are negotiated
Subject Recruitment may CommenceOR
OnCore “Opens Study to Accrual”
Data Use Agreement
(DUA)
Material Transfer
Agreement (MTA)
Clinical Trial Agreement
(CTA)
CTA is finalized and executed
*A one-time process to be completed by PI, not required at the initiation of each new research study.
Biosafety
Oth
er B
iosa
fety
Stem CellsGene
TransferRecombinant
DNASelect Agents
& Toxins
Research Infrastructure & Services to Support Research
2015 PILOT FUNDING COMMITMENTS >565kExtramural Success Awards (ESA)Pilot Study Research Program (PSRP)Bridge FundingTUPP Collaborative Proposal Preparation AwardsGraduate Research Day AwardsUGA/GRU Pilot Awards
Intermural Grant Program - Success
Intermural Grant Program - Success
$-
$2,000,000
$4,000,000
$6,000,000
$8,000,000
$10,000,000
$12,000,000
$14,000,000
$16,000,000
$18,000,000
FY2010 FY2011 FY2012 FY2013 FY2014
$851,898 $836,269 $945,919 $736,732 $525,744
$2,517,775
$13,899,576
$7,923,768
$17,506,731
$7,119,492
TotalExtramuralAwardsResultfromAllIGPAwards
AllIntramuralGrantAwards
Return on Investment (3 x return on investment)
(16.6 x return on investment)
(8.4 x return on investment)
(23.8 x return on investment)
(13.5 x return on investment)
Human Subject Research - SupportCLINICALTRIALSOFFICE
PI Portal – Future SystemsThe implementation of a PI Portal may provide opportunities to:
– Reduce faculty burden associated with the submission of grant proposals
– Improve post-award grant management – Ensure compliance with new regulatory requirements for awards.
Focus Groups are being established to gain knowledge, insight, and input that is crucial to understanding current challenges and designing future improvements to these processes.
• External:– Western IRB– NCI Central IRB (CIRB)– MOU with UGA– Utilize Central IRBs for Multi-Site research
IRBNet
• Electronic submission system• Internal and External IRBs• Quick Registration Process• IRBNet Training Available• IRBNet Resources Available
– Getting Started Checklists– Video Guides
Required Education for Researchersq All personnel involved in human subjects research
projects need CITI
q Complete the CITI certification at www.citiprogram.orgü Handout for How to Register for a CITI Account
q HIPAA - if accessing, using, or disclosing Protected Health Information (PHI)
IRB Resources
• Walk-in Wednesday: Health Sciences Campus• Departmental Training Available• Compliance Lunch-n-Learn Series• Research Academy Courses
Career Development 101 for Early-Career Investigators –Support of the Clinical Trials
Office
Mary Anne Park, RN, MSN, CCRCClinical Associate Professor of Surgery and NeurologyManager, Clinical Trials Office
What is the Clinical Trials Office?
• One-Stop Shop for Coordination of Clinical Trials
• Assistance with the clinical connection for translational research
How do I know who to call for assistance?
• CTO including Tumor Bank Specimens• Cancer Center Research Group• Sickle Cell• Neurology Movement Disorder• Psychiatry
Clinical Trials Office• Consortium of Research Nurse Clinicians, Research
Associates, and Research Assistants
• Provides Oversight and Management of Clinical Studies including– Research Study Initiation Processes– Compliance Approval Preparation– Financial Management– Conduct of Studies
• Studies that use any hospital resources must be submitted to this group to obtain hospital approval –This includes use of actual patients, hospital areas including labs, and data from medical records.
• CTO can assist in development of the materials RDS need to obtain hospital clearance.
Bottom Line • Should you need assistance in moving through any
portion of the clinical/translational research project, call the CTO for assistance.
ØOff-Campus AccessØeBooks and eJournals: 90,000+ eJournalsØGIL Express and Document Delivery ($7.00/article)ØChat ServiceØResearch Guides (LibGuides)ØUnique Databases and ResourcesØResearch and Teaching Assistance
Off-CampusAccess
Resources from both campuses can be accessed remotely by logging in with your Net ID and password that you use for email and other campus resources
SERVICES
Image Source, (CC BY-ND 2.0)
EmbeddedLibrariansØ Reference AssistanceØ Assistance with systematic reviewsØ Literature SearchingØ Collaboration on grant fundingØ Service on college/departmental committees, including
accreditation reviewsØ Teaching, online or face-to-faceØ Consultation on research projectsØ Help with citation management, including EndNoteØ Assistance with finding journals
PublishingAssistanceLearn about Copyright Transfer Agreements or Fair Use guidelines for using materials in D2L: http://guides.augusta.edu/copyright
MeasuringResearchImpact
Assistance to determinethe impact factor ofjournals in which you publish?Or, figuring out how to measurethe impact of your researchthrough social media (altmetrics)?
CompliancewithPublicAccessPolicies
Federal public accesspolicies resulting fromthe US Office of Science and Technology Policy memorandumof February 2013
AdditionalServices
Ø Interlibrary LoanØ Special Collections and Archives research assistanceØ Review of resources for accreditation and new degree
programs Ø Library exhibits and author presentation seminarsØ Government information assistance (Federal
Depository since 1962)
ScholarlyCommons
Ø Scholarly works of Augusta UØ Publications (pre-prints/post-prints), conference
presentations, theses and dissertations, student papers, white papers, historical archives
Ø Access through Google ScholarØ Freely availableØ Enhanced visibility – globallyØ Open Access Journals
Pure(formerlySciVal)
Ø Searchable database of experts at Augusta UØ Explore the profiles, publications, and grant data of
scholars within Augusta UØ Collaboration opportunities within Augusta U and
throughout the national Pure community (Elsevier)Ø Publications and grants listed for each faculty member
reflect their expertise in affiliated department(s)
FacultyProfiles(Pure)
Questions?Peter Shipman, MLIS
Assistant Professor and Dental Medicine and Cancer Librarian – Greenblatt Library
Kim Mears, MLISAssistant Professor and Scholarly Communications Librarian – Greenblatt Library
Kathy Davies, MLSAssociate Professor and Associate Director for Research – Greenblatt Library
Gail Kouame, MLISAssociate Professor andChair, Research & Education Services – Greenblatt Library
The Division of Communications and Marketing
Karla K. Leeper, PhDEVP for Strategic Communication, CMO
The Division of Communications and Marketing develops and executes a
comprehensive communications and marketing plan for the institution and provides
support to departments and units to ensure communications are consistent and effective as we bolster the institution’s reputation and
brand.
RELATIONSHIPS RESOURCESREPUTATION
www.augusta.edu/dcm
News and Communication
q PROMOTING grants, research results, awards, areas of expertise, events
q LEADERSHIP ACADEMY TRAININGmedia appearances, crisis communication, presentations
Faculty Support ServicesLaurie Bush, MBA, BBAManager, Faculty Support Services
What is Faculty Support Services?• We are a unit with the Human Resources Division• We serve the Health Sciences Campus, the
Summerville Campus, as well as the satellite campuses throughout the state
• Our primary goal:– Deliver a more efficient institutional operation as
it relates to faculty policies, procedures and the on-going delivery of faculty information to the Augusta University campus communities, the University System of Georgia and the general public
Process we help facilitate:• Faculty Recruitment• Faculty Appointment (hiring)
– Full-Time, Part-Time, and Clinical/Adjunct (volunteer)
• Academic Affairs/Faculty Related policies• Promotion & Tenure
– Pre- and Post-Tenure Review• Administrative Posts/Distinguished Faculty Titles• Joint/Secondary Appointments• Contract Renewals and Annual Contracts• Part-Time and Clinical/Adjunct Reappointments
Where are we located?
Augusta UniversityAnnex Building
(Corner of Walton Way and 15th Street)
Office Phone: (706) 721-1072
Website: www.augusta.edu/hr/faculty-support-ser
Questions?
Introduction to International InitiativesLD Newman, Assistant Vice President of International Initiatives
International Initiatives
• Created in January 2016 • Includes three units:
– International and Postdoctoral Services Office– Confucius Institute– Study Abroad
Appointing a postdoc
Hiring a postdoc as a J-1 or H-1B
• Hosting a J-1 Exchange Visitor– http://www.augusta.edu/diversity/ipso/international/in
