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Research Support Models to Strengthen and Enhance
Your OrganizationSRA International
2017
1
Presenter: Eleni RyalsCorporate Director, Partners HealthCare, Somerville, MA
1. Understand how a fee‐for‐service support model was developed and if it could work for your institution
2. Explore an integrated research administration model that can be adapted to your organization
3. Learn how these models can offer professional development opportunities for staff and meet the organizational, compliance and service needs of your organization
2
Learning Objectives
• Eleni Ryals has 19 years of broad experience in the Research Administration field and is currently Corporate Director in Research Management at Partners Healthcare. She developed the newest division within Research Management, Research Support Services, aimed at providing short‐ and long‐term research administration expertise to investigators and departments across the Partners HealthCare enterprise as well as institutions across the local Boston area.
• Her responsibilities also include oversight of the Award Management team for Massachusetts General Hospital, Brigham & Women’s Hospital and McLean Hospital.
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Eleni Ryals
Partners HealthCare
• Partners institutions maintain a total research budget of approximately $1.6 billion
• Partners hospitals are amongst the largest private hospital recipients of National Institutes of Health funding in the nation• Massachusetts General Hospital
and Brigham and Women’s Hospital are the 2 largest
• McLean Hospital is amongst the top 20
• Spaulding in the top 50.
Partners HealthCare is a not‐for‐profit, integrated health care system founded by Brigham and Women’s Hospital and Massachusetts General Hospital Includes community and specialty hospitals, a physician network, community
health centers, home care and other health related services
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Research at Partner’s Healthcare Systems
Partners Research Support Offices
• Research Management (RM) • Clinical Trials Office • Innovation• IRB• Research Computing • Research Applications
Hospitals
• Mass General Hospital • Brigham and Women
Hospital• McLean Hospital • Spaulding
Rehabilitation Hospital
• Research activities• Scientific direction • Initiate transactions • Space Management
• Operational support • Standard policies and processes• Analytical support • Facilitate communication and collaboration across hospitals
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• Many research departments at Partners and other research entities have had challenges when faced with gaps in personnel qualified to administer their research portfolios
• These gaps can lead to missed funding opportunities, reactive financial oversight, compliance issues, over‐stretched staff, and poor service to investigators
• Research Support Services (RSS) at Partners was created in 2014 to help fill these gaps by:• Offering a fee for service model comprised of a dedicated team that
can be deployed to meet the short or long term needs of investigators and research units
• Leveraging the resources created within are own central Research Management office
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Background
• Phase 1: Structured Moonlighting:• Senior staff offered the chance to work with different groups
while earning extra money• PIs and Departments found the assistance of great value even with a fee involved
• Phase 2: Short‐Term Pilot• Central RM Post‐Award Administrator re‐positioned for 6
months to fill a gap at a Partners department• Allowed us to really “test” the temporary support model
• Phase 3: Dedicated Team• Division with the central office devoted to offering short and
longer term assistance to both internal and external groups• Able to support central RM teams during downtime, serving as
both continued training for RSS and help with central gaps
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Initial Approach
• Knowledgeable in the entire grant life cycle including proposal preparation, award management, and financial analysis
• Committed to providing high‐caliber service, whether short or long term
• Flexible to work onsite with clients, or remotely
• Current on changes within the research environment including federal proposal requirements and software systems
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The RSS Team
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The RSS Team
Francis VanessaMatt Peggy Beau
Francis served as a Grants Administrator on the Research Management Post‐Award team. Francis maintained a complex post‐award portfolio while also working on the project group to develop and implement RSS. He has amassed a wealth of grant lifecycle skills and knowledge through his various RSS experiences working with several local research institutions.
Matt has a diverse background in the healthcare industry, including research experience in the academic, public, and private health sectors. Matt played a key role as a consultant to Mass Eye and Ear to assess and develop recommendations for improving their research administration department.
Beau has worked closely with several departments and Research Management on proposals, award management, and contracts. Prior to working with Partners Research Management, Beau spent 6 years working on research projects.
Peggy has worked in research administration for 15 years. She has provided technical expertise to institutions in Uganda, training grants staff and administrators both onsite and remotely. She advises U.S.‐based administrators on foreign subcontracting in resource‐limited settings.
Vanessa has specialized in working across various types of proposal mechanisms, including but not limited to the more complex National Institutes of Health P41 and P50 mechanisms, Substance Abuse and Mental Health Services Administration solicitations, and various private foundations.
• This “central” service was adopted as RSS staff demonstrated the flexibility to be onsite with the research departments
• Advantage by being part of a respected and well organized central office with documented policies, standard operating procedures, training resources, and a collegial culture
• For some departments, RSS serves as a long‐term support option due to knowledgeable staff that are paid on a per day or per hour model
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Organizational Adoption
Pre‐Award
Post‐Award/ Contracting
Research Finance
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Research Management at Partners
HospitalsHospitals
DepartmentsDepartmentsResearch Support
Services (RSS)
Research Support
Services (RSS)
For Clients:• Proposal preparation and submission to central office• Sponsor‐specific software data entry (i.e., NIH Assist)• Just‐in‐time and progress reports• Financial management, including:
• Reconciliation, spending projections & expense allocation • Subcontract management• Clinical trial invoicing• Formal assessment of research support operations• Training
For Research Management:• Gap coverage• Backlog and peak period assistance• Special projects
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RSS Services
• The central office has consistent practices in place while research divisions often differ – even within the same department• RSS staff must be able to adapt to new ways of doing things
• A clear “scope of work” for each assignment is important to avoid taking on ancillary research responsibilities • Examples of out‐of‐scope for RSS is coordinating visas, research
space, making travel arrangements for PIs
• Understanding and transparency that RSS is about providing department support• Centralized administrative support exists and is not part of this
fee‐for‐service model
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Setting Expectations
• Processes around establishing access to needed systems, shared drives, and other tools are critical
• Badge access to the client’s site typically required for RSS staff working onsite
• Web‐based form implemented to streamline client service requests
• An efficient billing system for staff to track hours, and be used to invoice clients is essential• Internal Partners client billing done via journal entries• External clients require a more robust billing procedure and can
include incidentals outside of the hourly rate
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Logistics
Clients across the Partners entityMGH ‐ Center for Global Health BWH ‐ Centers for Nursing Excellence
MGH ‐ Dermatology BWH ‐ Endocrine
MGH ‐ Foot & Ankle Lab BWH ‐ Neurosurgery
MGH ‐ Gastroenterology BWH ‐ OB/GYN
MGH ‐ Immunology BWH ‐ Pathology
MGH ‐ Nephrology BWH ‐ Pharmacoepidemiology
MGH ‐ Neurology BWH ‐ Psychiatry
MGH ‐ Nuclear Medicine BWH ‐ Sleep Medicine
MGH ‐ Orthopedics McLean – Various PIs
MGH ‐ Pediatrics Newton‐Wellesley Hospital
MGH ‐ Pulmonary Spaulding – Central Transition
MGH ‐ Psychiatry Partners Center for Connected Health
MGH ‐ Radiology Partners Corporate
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Expansion to local external entities, primarily through word of mouth, has enabled RSS to assist in the same capacity, but also helps to build bridges across the local Boston research administration arena.
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RSS Growth
• Current department and central support structure for research administration works well for organized and/or well funded hospital groups
• However, the structure creates challenges in hiring, training and accountability across the system as there is no standardization of roles and responsibilities of department grant administrators
• Handoffs between departments and central offices can hamper what should be a collaborative and interactive team approach to managing research portfolios
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Summary
The following are potential two service options that can be leveraged by divisions and departments based on needs:
• Integrated Department Administrator• Integrated Grant Administrator
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Summary
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Service OptionsIntegrated Department Administrator
(RM position at specific department)Integrated Grants Administrator
(RM position leveraged across departments)
Summary
• RM position assigned to a specific department. Roles & Responsibilities include departmental and central functions across the lifecycle. As determined jointly by Department and RM.
• RM position focused on defined set of grant activities. Responsibilities determined by RM. Other unique department responsibilities are out of scope and need to be managed locally. Internal controls established through business process rather than Dept./Central handoff.
Service Benefits for Investigator
• Leverage RM expertise and training resulting in shorter turnaround times on transactions because of reduced handoffs, standardized knowledge base
• Leverage RM expertise and training resulting in shorter turnaround times on transactions because of reduced handoffs, standardized knowledge base
Institutional Efficiencies
• Efficiency gained by eliminating handoffs for multiple grants related transactions by leveraging collective RM expertise and centralized approval authority.
• Limited ability to provide coverage beyond the assigned department
• Salary decisions made locally/independently thus minimized cost savings from equity across larger position pool
• Minimize handoffs and rework. Pool of staffing resources, that can be repositioned to meet volume and demand across departments.
• Salary decisions tempered by leveraging need for equity across colleagues
• Service improvements as well as efficiency gains for research areas that can be disrupted by turnover
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Service OptionsIntegrated Department Administrator
(RM position at specific department)Integrated Grants Administrator
(RM position leveraged across departments)
Location • Sits locally, attends RM meetings • Sits both locally and centrally, attends RM meetings
Reporting To: • RM/ Department • RM with dotted line to Department
Funded By: • Dept./Division/PI and RM • Institution
Training• Required RM training, and work experience in
Department or RM to become authorized approver. Local training for department responsibilities
• Required to attend current trainings, specific hands on training on systems and specific processes including proposal submissions, salary management and fund monitoring
• Structured Job Shadowing and cross training across RM and Hospital Departments
• Requirement to demonstrate competency based on training
Hiring/Staffing • Hiring jointly RM and Department • Hiring by RM
Roles & Responsibilities • Determined jointly by RM and Department
• Determined by RM. Specialized role for grants functions only. Other unique department admin responsibilities out of scope
• Merger of traditional department and central grants support into a single Research Support Team
• Creates new role of Integrated Grants Administrator (IGA) that combines departmental and central responsibilities
• Team managed and anchored centrally, but physically dispersed to be proximate to investigators as much as possible
• Internal controls established within integrated team to ensure compliance risks are mitigated
• Signing authority held by Managers, with transaction‐based authority for Senior staff
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Integrated Support Model
Central point of contact for PI
Reduced handoffs
Improved response time
Improved teamwork and better portfolio coverage
Located in proximity to PIs and research teams
Broader responsibilities and access to systems
Expanded professional development
More interactive approach and relationship with Signing Officials
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Benefits of the Integrated GA (IGA)
Depa
rtmen
t RA
• Works with PI to build administrative, compliance, and budget sections of application
Central
GA
• Reviews for adherence to sponsor guidelines, compliance and institutional risk.
• Provides RA/PI with comments prior to submission
• Submits to sponsor on behalf of the institution
26
Sample Integrated GA Responsibilities & Benefits: Proposal Submissions
DA works with PI to develop proposal
DA/PI draft proposal (and potentially create internal record)
Pre‐Award reviews draft, and creates internal record if needed
Pre‐Award provides feedback on proposal draft versions
DA/PI make necessary changes
DA/PI complete final proposal
Pre‐Award reviews final proposal and updates internal record
NIH Proposal?
YES Pre‐Award submits to eRA Commons
PI /DA or Pre‐Award submit through sponsor’s requested method
NO
GA works with PI to develop proposal
GA with signing authority submits to Sponsor; without authority to Manager for final review & submission
2 – 5 Steps, internal controls imbedded in team
< $500Kproject period, domestic, & no cost share?
Integrated
GA
• Works with PI to build all necessary components of proposal, reviewing againstsponsor and institutional guidelines and policies
• May submit directly to sponsor if holding Signing Authority, or to Manager for review and submission
Current State 8 Steps, requiring numerous handoffs across staff
Future State:
If NO, requires Manager approval
YES
Current Process Integrated GA (IGA)• Involves 3 individuals
• Central Pre Award GA – receives award, sets up fund, communicates with Department RA to begin allocating expenses
• Department RA – confirms subcontract budgets prior to fund set up
• Central Grant Accountant –initiates subcontract‐out agreement
• Integrated GA takes full ownership of award upon receipt of NOA. Confirms accuracy of budget for subcontracts as necessary. Sets up fund number and maintains records of all project information.
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Sample Integrated GA Responsibilities & BenefitsAward Set Up
Benefits for Award Set Up Process
One point of contact once award is received Ability to immediately establish fund and start work Faster execution of outgoing subcontracts
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Transaction Scope
IGA• Proposal Submission• Just‐In‐Time• Progress Reports • Award and Renewal Setup• Salary Allocations• Prior Approval Requests• Fund Management• Sponsor Contact• Incoming / Outgoing
Subcontract Modifications• Outgoing New Agreements • Federal & Non‐Federal FSRʹs • Journal Entries• Effort Reporting
Specialized• Contracting• Invoicing, including Letter of
Credit• Accounts Receivable• Cash Collections• Clinical Trial Budgeting• FFATA Reporting• Audit Coordination• Effort Reporting Oversight
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Overview of Integrated Grants Administrator
Transaction Training Needs Access Requirements Central Internal Controls
Proposal Submission Enough to be an authorized signatory eRA Commons SO Access ; Grants.gov Access; Other Sponsor Portal Access; Pre‐Award Signatory;
Proposals over $500K; Foreign Component or Sponsor; Cost Sharing;
Just‐In‐Time Enough to be an authorized signatory eRA Commons SO Access ; Pre‐Award Signatory;
Federal Contract JIT equivalent;
Progress Reports Enough to be an authorized signatory eRA Commons SO Access ; Pre‐Award Signatory;
Greater than 25% unobligated balance; Sponsor‐imposed due dates due to scientific/milestone delays;
Award and Renewal Setup / Award Changes
NOA review and understanding of terms; Understanding of federal/foundation key guidelines & resources; IE data capture; IE/PS interface;
Central Mailbox / InfoEd / PeopleSoft Interface Access
NIH Budget to Authorized Quarterly Review; QC check on ___%;
Salary Allocations Knowledgeable in effort vs salary compliance regs; prior approval requirements;
HCM; Labor Reports; Effort Reports Over 90 days; Greater than 25% effort reduction; Mechanisms T, K, F; Over NIH Salary Cap; PI on Grant;
Prior Approval Requests Knowledgeable in federal requirements; keen to review non‐fed awards for review;
Authorized Signatory Requests to carry forward unobligated balances;
Fund Management Knowledgeable in financial analysis: burn rates, accelerated spending, deficit spending;
PeopleSoft Queries & Reports Accelerated Spending > 50%; Renewals > $50K, Future End Date Cost Xfers;
Sponsor Contact Knowledgeable in roles and authority at the Sponsor; Due diligence in PI inclusion;
Authorized Signatory Transfers; Compliance Matters;
Incoming / Outgoing Subcontract Modifications
Knowledgeable in standard contracting, in particular budget & scope change thresholds
Authorized Signatory Term and Condition Changes ; Budget changes over 10%
Outgoing New Agreements(non‐trial)
Understanding of prime award terms; Template Usage
Authorized Signatory High‐Risk Subcontractors; Non‐FDP templates;
Federal & Non‐Federal FSR's (Drafting & Approval Process)
Knowledgeable in allowable costs, IDC & FB rate application, unobligated balances, deficit recording, outgoing subcontract invoicing;
Authorized Signatory; PeopleSoft Queries & Reports
NIH P, U, T mechanisms; Awards >$1M;
Journal Entries (Creation, Review & Approval)
Knowledgeable in cost transfer regulations PeopleSoft Queries & Reports; > 90 Day Entries; over $50K;
• Approval at the executive and scientific leadership levels of both the department and central offices is necessary
• Based on size, may be suitable for smaller entities, or for specific departments within a larger institution
• Ancillary department responsibilities need to be identified and separated from research management functions• Will require buy‐in from department leadership• New job descriptions for staff required
• A cross‐training plan is key to integrating an existing DA/Central structure as both ʺDAʺ and ʺCentralʺ each have knowledge and need to be involved in training each other
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Transitioning to an Integrated Model
Specialized (Finance) Role
Centralized Integrated Grants Administrator
Scope of Responsibility
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Department Responsibilities (research)
Central Responsibilities
Space ManagementAudit operationsPurchasingClinical Research & Trial Management
Department Responsibilities (non‐research)
HR (i.e., visa, recruitment)Office/Lab AdministrationTroubleshooter/Navigator Systems access/PASTravel conference registration and reimbursement
Educate Faculty and Staff on Research Policies and ProceduresEffort ReportingProtocol Support IACUCFund/Financial ManagementSalary ManagementProposal DevelopmentJIT DocumentationProgress Reports Preparation
Proposal Review and SubmissionJIT Review and SubmissionProgress Reports Review and SubmissionFund SetupSalariesAdvance AccountsCarryforwardOther Prior Approvals (effort change, no cost extensions, etc.)Equipment RequisitionsBilling AgreementsAgreement ModificationsJournalsFinancial Reports
Billing, including LOCA/R, Cash CollectionsUG & Sponsor‐Specific AuditResidual Balance TransfersFund Inactivation
Centralized (Specialized)
Centralized Integrated Grants Administrator
Scope of Responsibility
32
Department Responsibilities (research)
Central Responsibilities
Space ManagementAudit operationsPurchasingClinical Research & Trial Management
Department Responsibilities (non‐research)
HR (i.e., visa, recruitment)Office/Lab AdministrationTroubleshooter/Navigator Systems access/PASTravel conference registration and reimbursement
Educate Faculty and Staff on Research Policies and ProceduresEffort ReportingProtocol Support IACUCFund/Financial ManagementSalary ManagementProposal DevelopmentJIT DocumentationProgress Reports Preparation
Proposal Review and SubmissionJIT Review and SubmissionProgress Reports Review and SubmissionFund SetupSalariesAdvance AccountsCarryforwardOther Prior Approvals (effort change, no cost extensions, etc.)Equipment RequisitionsBilling AgreementsAgreement ModificationsJournalsFinancial Reports
Billing, including LOCA/R, Cash CollectionsUG & Sponsor‐Specific AuditResidual Balance TransfersFund Inactivation