Concurrent Sessions

The Spectrum Health Department of Research (SHOR) supports all of the research activity at Spectrum Health, a mid-size non-academic affiliated, not-for-profit health system that includes 14 hospitals in Western Michigan. In November 2018, SHOR launched a process improvement tool titled RiHub - Research Improvement Hub. The RiHub in SHOR was developed with two goals in mind: 1) To promote excellence in research administration by adopting cutting edge tools and smart, lean processes, and; 2) To enhance department culture by promoting team-based all-inclusive problem-solving. This presentation will tell the story of how we came to deciding to launch the RiHub, describe a few of our current projects, and summarize reactions six months in that may help you in your current academic role.

Content level: Intermediate

Learning objectives:

1. Understand how the Kaizen methodology of process improvement can be applied to administrative tasks.
2. Walk away with inspiration to consider using some of the methodology outlined in this initiative.

Prerequisites: None

Speaker(s): Shanta Layton, Director, Pediatric Research, Helen DeVos Children's Hospital/Spectrum Health

This session will share the experiences of first-time users of electronic protocol submission and review systems. We will share guidance and/or recommendations for walking through protocol review and approval using current polices and procedures.

Content level: Basic

Learning objectives:

1. Experience best practice recommendations for using an electronic protocol review system.
2. Learn how institutions can adapt electronic review to current policies and procedures.

Prerequisites: None

Speaker(s): Andrew Glenn, Compliance Specialist; Chanell Rome, eRA Business Analyst; Timothy Sparklin, MSW, Research Compliance Officer, University of Maryland, Baltimore County

The increased complexity and changing nature of research administration led us to evaluate the models we use institutionally to provide services to faculty. This session will look at Yale’s approach to regionalizing research administration services for academic and non-academic departments by raising the level of service to Principal Investigators while increasing compliance and mitigating risk. During this session, we will discuss how the current model was designed and implemented on our campus, provide the challenges and successes during the transition, and provide an opportunity to have a discussion about all aspects of this model.

Content level: Intermediate

Learning objectives:

1. Identify the types of services that can be offered and how to successfully brand.
2. Understand the benefits, challenges and successes in implementing a shared service.

Prerequisites: None

Speaker(s): Joanne Bentley, MBA, Senior Director, Yale University

This presentation will focus on the many responsibilities and duties that a department administrator’s encounter while assisting faculty members with institutional transfers. We will provide a checklist of specific duties and "best practices" that will facilitate a seamless transition and considerations for bringing on new or more senior faculty. We will discuss case studies and real-life scenarios so that participants can dialogue on "what would you do now" or "how would you handle this".

Content level: Basic

Learning objectives:

1. Better understand what is needed and what he/she needs to do when Investigators are transferring into their University.
2. Distinguish the particular challenges of on-boarding junior versus senior faculty.

Prerequisites: None

Speaker(s): William Hoffman, MAS, Research Administrator, University of Maryland, Baltimore School of Dentistry, Office of the Dean; Karen Sack, Administrator, Department of Physical Therapy & Rehabilitation Science, University of Maryland, Baltimore, School of Medicine; Janet Simons, MBA, Director, Research Policy, University of Maryland, Baltimore ORD Sponsored Programs Administration

This session will cover the important components of a Clinical Trial Agreement, identify areas where research sites and for-profit sponsors spend the most time in negotiation, as well as describe best practice concepts to improve Clinical Trial Agreement throughput while minimizing the risk of subsidizing a for-profit sponsor.

Content level: Intermediate

Learning objectives:

1. Identify 3 areas of importance within a Clinical Trial Agreement from a research site perspective.
2. Describe 3 concepts to improve negotiation outcomes.

Prerequisites: None

Speaker(s): Joe Fugitt, Manager, Research Finance, Spectrum Health

During the accreditation process, the Council for Higher Education Initiatives (CHEA) asks colleges and universities “Is the institution fulfilling its mission and achieving its goals?” The answer to this question lies within both academic and administrative units campus-wide. Goals must be related to the institution’s overall strategic plan and must be measurable. Sponsored Programs offices are no exception to this process and many research administrators are now being asked to present their yearly objectives in a strictly quantifiable manner. This is a change for many, and impacts everything from staff evaluations to application and award projections. This interactive session, for those who have and will go through this process, will provide useful tips for successfully meeting institutional needs.

Content level: Intermediate

Learning objectives:

1. Create realistic and measurable goals as you relate to the institutional strategic plan.
2. Create “unit level” strategic plans for sponsored programs offices that relate to the institutional mission.

Prerequisites: None

Speaker(s): Dominic Esposito, CRA, Director of Corporate, Government and Foundation Relations, The College of New Rochelle

Every university should have policies in place to manage all funds consistent with federal, state, and local laws, and with the specific terms and conditions of any gift, grant or contracts. This session will discuss the classification of external funding as a gift or sponsored award, including the relationship to Administrative Requirements Cost Principles and Audit Requirements for US Federal Awards. It will also help you answer the following questions: What internal controls exist for Foundations? Does our University have a gift policy? Who has the final word on gift vs sponsored funding?

Content level: Basic

Learning objectives:

1. Participants will critique real life case studies to demonstrate knowledge gained.
2. Participants will gain the ability differentiate between the terms gift and sponsored agreements.

Prerequisites: None

Speaker(s): Denise Clark, Associate Vice President for Research, University of Maryland; Ann Holmes, Assistant Dean, College of Behavioral and Social Sciences, University of Maryland

It is scientifically and ethically imperative for researchers to understand that it is a key commitment to report the results of clinical trials to research participants, so the advanced knowledge can be utilized collectively to make informed medical decisions. This session will discuss the most recent federal mandates, pertinent requirements of clinical trials disclosure and good practice. The presenters will share the approach that Rutgers, The State University of New Jersey, took to establish a robust, effective program for clinical trials registration and results reporting. Rutgers’ Human Subjects Protection Program (HSPP) has adopted a proactive plan to identify key issues and facilitate investigator to stay compliant within ClinicalTrials.gov records through the HSPP’s guidance, including a website and ongoing, customized trainings.

Content level: Intermediate

Learning objectives:

1. Describe why clinical trials disclosure matters and List resources and tools to assist investigators and organizations in maintaining compliance for clinical trials disclosure.
2. Identify key elements to establish a system in your organization to facilitate and monitor clinical trials registration and results reporting.

Prerequisites: None

Speaker(s): Cheryl Forst, RN, BSN, CCRP, Director, Human Subjects Protection Senior Analysts Rutgers, The State University of New Jersey; Rebecca Niem-Tzu Chen, MS, MEd, CCRP, Human Subjects Protection Senior Analyst, Rutgers, The State University of New Jersey A collection of great CSS tools and resources can be found at html-css-js.com: code beautifier, cheat sheet, style generators, useful links and more.

Research teams are passionate about all of their studies, yet research organizations are responsible for conducting only high-quality research and doing so with limited resources. This presentation will discuss the use of a review and selection process, known as Research Administrative Preauthorization (RAP), used at Aurora Health Care (AHC) to screen studies for merit, compliance, resource needs, and other variables important to a research organization. All research proposals at AHC must be vetted through RAP, thereby allowing the institution to maximize the amount and quality of research conducted by the institution, while also providing oversight by research leadership, guidance from research support teams, and feedback from other researchers. This presentation will provide an overview of the preauthorization process and its purpose, support required for effective administration, lessons learned, and system-wide implementation processes.

Content level: Advanced

Learning objectives:

1. Determine whether research preauthorization would be useful to their organization.
2. Develop a research preauthorization process that is quick and effective.

Prerequisites: None

Speaker(s): Nina Garlie, PhD, Director of Patient-Centered Research for Neuroscience and Emerging Areas; Mindy Waite, PhD, Manager, Research Grants & Projects, Aurora Health Care

The revised Common Rule, released by the U.S. Department of Health and Human Services (DHHS), is the first major change to that set of regulations in more than 25 years. Human research protection professionals will be subject to following the revised Common Rule provisions starting on its effective and compliance date, January 21, 2019. This session will review the major changes and highlight specific changes with examples of implementation approaches and considerations. This session will also provide an overview of considerations for working with both sets of regulations (pre-2018 and 2018) and transitioning studies.

Content level: Intermediate

Learning objectives:

1. List the major changes in the revised Common Rule and implementation examples.
2. Identify best practices when working within both sets of rules.

Prerequisites: None

Speaker(s): Philip Cola, PhD, Associate Professor Design & Innovation Organizational Behavior Associate Director, Academic Affairs Doctor of Management Programs Weatherhead School of Management, Case Western Reserve University; Madeleine Williams, MA, Senior Consultant, Huron Consulting Group

This interactive session will compare and describe the general organization of universities with Veterans Affairs (VA) Medical Centers, discuss various differences the structure provides, present what is needed for the VA in order to make working with the VA smoother. This will be an interactive presentation

Content level: Basic

Learning objectives:

1. Describe how the VA is organized.
2. Identify the contact people within the VA.

Prerequisites: None

Speaker(s): Rene Hearns, MPA, CRA, Assistant Director 'IIRECC'/Study Coordinator/Budget Analyst, Louis Stokes Cleveland VA Medical Center

This session will address the following topics for research administrators that are involved in clinical trial activity related to biorepositories: discussion of various repository models, ideas for repository management considerations, review of multiple regulatory considerations (HHS, FDA, and HIPAA), impact on informed consent, implications from the revised Common Rule NPRM discussion, biospecimen research scenarios for both current and future regulatory considerations.

Content level: Intermediate

Learning objectives:

1. Identify different biorepository approaches and models for clinical research.
2. Understand the impact of different regulations on biospecimen clinical research.

Prerequisites: None

Speaker(s): Philip Cola, PhD, Associate Professor Design & Innovation Organizational Behavior Associate Director, Academic Affairs Doctor of Management Programs Weatherhead School of Management, Case Western Reserve University; Madeleine Williams, MA, Senior Consultant, Huron Consulting Group

Almost every research institution must engage in the process of negotiating federal indirect rates. Non-profits face unique challenges under the Uniform Guidance in preparing, submitting and negotiating indirect rates. As we go through this process, many of us often wonder if we have done everything we can do within the constraints of federal regulations in order to maximize our institution’s negotiated indirect rate and resulting indirect cost recovery. In this session, we will discuss strategies that may be employed to maximize indirect cost recovery, both in the preparation of your indirect rate proposal as well as during the subsequent rate negotiation and budgeting of indirect costs on grants and contracts. Participants will be encouraged to share their experiences concerning the indirect rate process.

Content level: Basic

Learning objectives:

1. Identify what an indirect cost rate is, its importance and the various types of costs recovered through the indirect rate.
2. Explore different types of rates and how they impact recovery and understand the process for preparing, submitting and negotiating the rate under the Uniform Guidance.

Prerequisites: None

Speaker(s): Alex Weekes, CPA, Principal, ML Weekes & Company, PC

Organizations around the world are adopting the Lean and Six Sigma methodologies, and this includes the Leader Standard Work sheet. The purpose of the Leader Standard Work sheet is to build a framework around your position, improve processes, and to help you become a better leader. If done correctly, you should be able to hand this piece of paper to someone brand new and they would have instant knowledge of what you do. Unfortunately, the usual template that comes out of the box from your employer usually doesn’t fit the life of a Research Administrator. We have a different sort of daily work that, at times, is inconsistent and 90% variable from day to day. But do not despair, with only a few changes we can turn the standard Leader Standard Work sheet into a useful tool for the world of research leadership.

Content level: Intermediate

Learning objectives:

1. Recognize the purpose of the Leader Standard Work sheet.
2. Practice creating a personal Leader Standard Work sheet based on your current workflow.

Prerequisites: None

Speaker(s): Holly Zink, MSA, Manager of Research Project Development and Education, Children's Mercy Hospital

We (hopefully) learn from our mistakes so come and learn from my mistakes (and a few successes) in order to avoid the pitfalls in your own leadership journey. This session will cover a wide variety of leadership lessons to help managers at all levels as they deal with a changing environment. We’ll use real-life vignettes and case studies that you can apply to your own professional and personal life. The session will include dealing with issues such as: employee turnover, low morale, financial challenges, mergers and acquisitions, employee layoffs, employee terminations, communications, legal challenges, embezzlement, disasters and many more environmental changes that need to be managed. Come learn from an established leader with more than 30 years of executive management experience at a variety of levels ranging from head french fry cook to CEO.

Content level: Intermediate

Learning objectives:

1. Enhance awareness, reflective thinking and commitment towards effective leadership.
2. Gain knowledge and understanding of good leadership behaviors and models.

Prerequisites: None

Speaker(s): Kevin Titus, MBA, Business Director, Cincinnati Children's Hospital

This presentation will identify key issues impacting university-industry collaborations and how to develop an agreement that works for all stakeholders at both parties.

Content level: Intermediate

Learning objectives:

1. Identify the key issues impacting university-industry collaborations.
2. Discover how to develop an agreement that works for all stakeholders at both parties.

Prerequisites: None

Speaker(s): Carlos Braxton, Associate Director, Office of Research Administration, Johns Hopkins University School of Medicine; Gayle Mowbray Walters, MS, Director, Consortia Services, Johns Hopkins University

PHS policy allows for a subawardee or collaborator to rely upon the prime awardees Financial Conflict of Interest policy and oversight. As evidenced by the Federal Demonstration Partnership’s Risk Assessment Questionnaire, that comes with above average risk to the prime. Are you uncomfortable with increased risk for conflicts of interest associated with your subrecipients or research collaborators? This session will explore the considerations for accepting oversight compliance for subawardees, improved ways to monitor and mitigate those risks.

Content level: Intermediate

Learning objectives:

1. Recognize the responsibility and risks inherent in assuming responsibility for subawardees’ financial conflict of interest oversight.
2. Identify solutions for mitigating those risks.

Prerequisites: None

Speaker(s): Susan Sedwick, PhD, CRA, Senior Consulting Associate, Attain LLC

Each of us will at some stage be in a position where we must deal with a difficult person in our office, in our institution, or from an external partner. These interactions, if not dealt with well, can become a source of anxiety, and decreased satisfaction and job productivity. This session will examine how to recognize when we and/or others create difficult situations, strategies for dealing with difficult people and situations, dealing with aggression, and shifting the balance of power.

Content level: Advanced

Learning objectives:

1. To recognize the roles, we play as leaders, in contributing to and/or escalating office conflict situations.
2. To develop essential communication skills to deal effectively with complex personalities and situations so that we can mitigate circumstances that have a potentially detrimental impact on the research office.

Prerequisites: None

Speaker(s): Debra Schaller-Demers, MSOM, Director, Research Outreach and Compliance Tri-I RCR Course Director Administrative Member, Tri-SCI ESCRO IACUC, IBC, and Export Control Administration, Memorial Sloan Kettering Cancer Center

Large multi-site trials have unique challenges and the risk increases exponentially when dealing with remote and/or foreign sites. Training is critically important and while initial start-up training for sites sets the stage for ensuring compliance, the ability to assess situations and provide on-demand training when issues arise is essential. How do you deal with access to technology, language barriers, and differences in cultural norms? This session will address effective ways to assess compliance and conformity and proven solutions. Participants are encouraged to be willing to discuss unique challenges and be ready to share creative solutions.

Content level: Basic

Learning objectives:

1. Identify key areas for assessment in ongoing trials.
2. Understand the key elements of a good quality improvement program for clinical studies.

Prerequisites: None

Speaker(s): Susan Sedwick, PhD, CRA, Senior Consulting Associate, Attain LLC; Michele Vaughn, Senior Clinical Lead-Oncology, IQVIA

As the complexity of today's most pressing research requires collaboration and team science, grant proposals have become more complex to plan and coordinate. This session will present strategies to manage the proposal process and help investigators prepare competitive large-scale, collaborative grant proposals, which differ in many ways from individual research grants. The speaker will describe typical proposal components, provide examples of complex, large-scale proposals from many funding agencies, and consider the organizational challenges of these proposals. Other topics will include advice on organizing research teams, assigning responsibilities for developing the proposal narrative and budget, reviewing and editing proposal narratives, and submitting the final proposal package. Audience participation and questions are highly encouraged.

Content level: Intermediate

Learning objectives:

1. Describe challenges and list strategies that will enhance the development of complex, large-scale, multi-disciplinary grant proposals.
2. Define interdisciplinary research, team science and collaboration and understand the increased emphasis on team science and collaboration in grant programs.

Prerequisites: None

Speaker(s): Marjorie Piechowski, PhD, Emerita Director of Research Support, University of Wisconsin-Milwaukee

This presentation will focus on the current and future global impacts of the disease, the comprehensive funding opportunities to accomplish the research goals of the National Plan, and how your institution or organization can contribute.

Content level: Intermediate

Learning objectives:

1. Understanding research opportunities and how they are awarded, within the NIH and the NIA.
2. How to increase your organizations Success Rate? With the recent talks of a Government Shutdown, what does that mean for a biomedical research organization that runs a 24X7 operation?

Prerequisites: None

Speaker(s): Patrick Shirdon, B.A. Economics and Finance, M.S. in Business Management, Director of Management for the National Institute on Aging, National Institute of Health

Where do you start if your department is awarded $3M/year to internally fund a specific area of research? Do you have a budget template ready to go? Will the submission be electronic? Who is even invited to submit? How is cost-share collected? What does the accounting look like? These are just a few of the questions that ultimately come up when a department is asked to effectively manage an internal call for proposals, whether the funding be internal, state, industry or federal. We will discuss a cradle to grave process to ensure that all aspects of the program have been managed, whether it is writing an RFP (request for proposal), communicating the terms and conditions to your audience, developing an internal submission process, tracking cost-share or just managing it on a daily basis. Come with your own processes too! I hope to learn from you as well.

Content level: Basic

Learning objectives:

1. Understand how to put together an internal call at a departmental level.
2. Understand programmatic intricacies of this type of award.

Prerequisites: None

Speaker(s): Rhonda Moyer, MPM, Director, Finance & Administration, Carnegie Mellon University, College of Engineering

Managing a research administration office can be a challenging but highly rewarding experience. No matter the size of your office, significant departmental efficiencies can be realized by developing a vibrant team of research administrators that enhance your organization’s goals and culture. Drawing upon their individual experiences, this discussion group, led by seasoned research managers, will give insight into setting up a cohesive research administration office and how to hire the right team for the job at hand. We will share tips for setting team culture for your staff, discussions of unique ways of managing your team, and pitfalls experienced along the way. Attendees will be encouraged to provide examples from their own experiences to enrich the discussion.

Content level: Intermediate

Learning objectives:

1. Recognize how to create the right team for a research administration enterprise no matter the discipline.
2. Identify qualities and traits that will foster a culture of teamwork in your overall team environment and how to manage your team environment through conflicting personalities and priorities.

Prerequisites: None

Speaker(s): Melissa Karby, Director of Research Administration, School of Dentistry; Teresa Herrick, MS, CRA, Research Process Manager, School for Environment and Sustainability; Nicholas Prieur, Research Process Senior Manager, SRC - Youth and Social Issues, University of Michigan Access the premium HTML editor and use the features like the tag manager, code cleaner, color picker.

Colleges and universities receiving direct federal awards are typically required to have a federally negotiated facilities and administrative (“F&A”) cost rate in order to receive reimbursement for indirect costs. For most people, however, the process of preparing, submitting, and negotiating the F&A rate proposal under the Uniform Guidance can appear overly technical and painfully detailed. This session is intended for anyone who is new to the F&A process or would simply like to better understand the basic requirements, inputs and objectives that make up this calculation. The discussion will include a high-level perspective regarding how the regulations, financial and other data inputs, and submission and negotiation processes work together and will provide practical insight into the application of the F&A rate to the organization’s awards. Participants are encouraged to share their role in as well as their experience with the indirect rate process at their institution.

Learning objectives:

1. Identify what an F&A rate is, its importance and the various types of costs recovered through the F&A rate.
2. Explore different types of rates and how they impact recovery and understand the process for preparing, submitting and negotiating the rate under the Uniform Guidance.

Prerequisites: None

Speaker(s): Alex Weekes, CPA, Principal, ML Weekes & Company, PC

This session will examine the importance of having appropriate protections for research data in sponsored agreements. Among the topics covered in this session will be ownership rights in data, data sharing polices of NIH and other sponsors, issues involving clinical data, data use agreements, disclosures of Protected Health Information/Personally Identifiable Information, and potential implications of General Data Protection Regulation.

Content level: Intermediate

Learning objectives:

1. Identify and understand the issues that arise for research universities surrounding the protection of data
2. Develop strategies for mitigating risk when negotiating data provisions in sponsored agreements

Prerequisites: None

Speaker(s): Tom Burns, JD, MBA, Director, ORA, Johns Hopkins University School of Medicine

There are many times through our communications when we wonder if the PI doesn't understand our role as Research Administrators and vice-versa. This session will provide insight on how to communicate effectively to a PI as well as how we can train our PI's to communicate so that we can support them.

Content level: Basic

Learning objectives:

1. Decode the science language and how to effectively communicate to their PIs.
2. Provide a basis of support to effectively work with each other.

Prerequisites: None

Speaker(s): Jason Claes, MBA, MSM, GRCRA, Assistant Director, Research Accounting, University of Cincinnati

Almost all sponsors, and NSF in particular, consider the potential of a project to benefit society or advance desired societal outcomes as part of their merit review process. Researchers frequently struggle with how to convey this information in an impactful way in their proposals, and often turn to us as Research Administrators to provide guidance in writing this section. This session will provide an historical framework for Broader Impacts; strategies for creating an effective Broader Impact Plan; and some tools and resources you can bring back to your home institution to use with your PIs.

Content level: Intermediate

Learning objectives:

1. Identify the key components of successful proposal development and submission.
2. Provide information on how to develop skills to effectively communicate and collaborate with faculty during the proposal process.

Prerequisites: None

Speaker(s): Anne Schauer, MA, CRA, Director of Research and Sponsored Programs, Miami University

Succession planning helps organizations to ensure there are capable and experienced candidates to fill vacancies especially at the leadership level but is most successful when it is incorporated into a more holistic career ladder approach to retain high potential employees. Let’s face it: if you think they are worth keeping, someone else will think they are worth recruiting. So how do you identify high potential candidates, invest in their professional development, and mentor them to be able to hit the ground running when the opportunity arises. This session will focus on: WHO you identify, WHAT professional development opportunities do you afford them, WHEN do you assign greater responsibility, WHERE do you find them and HOW do you keep them for the long term.

Content level: Advanced

Learning objectives:

1. Identify high potential talent in your organization or even elsewhere that can be mentored.
2. Develop a succession plan that allows for gradual increases in responsibility during the mentoring period.

Prerequisites: None

Speaker(s): Susan Sedwick, PhD, CRA, Senior Consulting Associate, Attain LLC; Marianne Woods, PhD, JD, Faculty and Program Director Master of Science in Research Administration Krieger School of Arts and Sciences Advanced Academic Programs, Johns Hopkins University

This presentation is an interactive session to discuss patient recruitment for clinical research studies sponsored by pharmaceutical companies. It will engage the audience requesting them to comment on their current perspective and comparing it to the current practices of a top performing pharmaceutical company. We will first review how a pharmaceutical recruitment strategy is developed, the site selection process, the different media forms which include the shift of paper to electronic advertising, site and patient matching, media, retention, and the vast amount of resources it takes to execute a recruiting strategy. Next we will examine how the recruitment packages are delivered to the institutions gathered audience feedback. Patient engagement comments are welcomed as well. Lastly, we will look at how we can improve the communications for all parties involved.

Content level: Intermediate

Learning objectives:

1. Identify high potential talent in your organization or even elsewhere that can be mentored.
2. Develop a succession plan that allows for gradual increases in responsibility during the mentoring period.

Prerequisites: None

Speaker(s): Michele Sawicki, MBA, Senior Manager, Abbvie

The Clinical Trial Agreement (CTA) is often thought of primarily as a legal document, but it is equally important for the parties to use the CTA terms and conditions to set operational expectations of one another. This presentation will explore the operational implications of various CTA provisions and offer tips and strategies for negotiating contract language that does not conflict with site operations.

Content level: Basic

Learning objectives:

1. Identify CTA provisions that may negatively impact or conflict with site operations.
2. Negotiate CTA provisions with regard to time frames, notice, and access that harmonize with site operations.

Prerequisites: None

Speaker(s): Kristine Martens-Ackeret, JD, Associate Director, Office of Sponsored Programs, Ann & Robert H. Lurie Children's Hosptal of Chicago; Allison Teresa Siebold-Guzman, JD, Contracts Officer, Office of Sponsored Research, Northwestern University

Positive delegation skills are one of the most effective ways for research management leaders to enhance their organizational position. However, leaders frequently find themselves at odds when it comes to delegating; after all, what made them a leader was their ability to get the job done and giving their strength away seems counter-intuitive to success. This session will teach you some of the important aspects of effective delegation that will make your office more successful and effective in the research management workplace.

Content level: Intermediate

Learning objectives:

1. To recognize when it is appropriate to delegate tasks to others.
2. To explore, assess, and adapt various methods of delegation to meet your research office needs.

Prerequisites: None

Speaker(s): Debra Schaller-Demers, MSOM, Director, Research Outreach and Compliance Tri-I RCR Course Director Administrative Member, Tri-SCI ESCRO IACUC, IBC, and Export Control Administration, Memorial Sloan Kettering Cancer Center

In this session, we’ll describe the review process to submit a proposal from initiating PI meeting through portal submission. You’ll receive FAQs, resources, and best practices to put on track for a successful submission!

Content level: Basic

Learning objectives:

1. List RFA/PA requirements and how to prepare for initial proposal meeting.
2. Identify tips and tools for effective time management.

Prerequisites: None

Speaker(s): Hilah Zia, (MPA) Master of Public Administration, Research Business Manager, Children's National Medical System

Successful teams hinge on clear roles, responsibilities, and expectations. Without these rules in place, important tasks may be missed or duplicated, team members may feel uncertain of their value or purpose, and, ultimately, the project may fail. To avoid this terrible end, all projects should begin with a clear definition of roles and responsibilities. The RASIC matrix is a helpful management tool to establish roles and responsibilities on a project or in your office workflow. “RASIC” is an acronym which stands for “Responsible”, “Approving”, “Supporting”, “Informed” and “Consulted”.

You can use these designations to define your relationship to other employees for different roles as you work on a shared project. Why use it: RASIC is particularly useful in matrix managed organizations, in which multiple business units work together on a project, as RASIC can be used to clarify ambiguities and establish clear roles, responsibility and accountability for each party. Where to use it: RASIC charts can be used at any level, where clarity of responsibility and accountability is required.

The RASIC chart is a flexible tool that can be tailored and constructed to fit the needs of different industries, individual programs and activities. When to use it: To clarify roles, responsibility, and accountability between parties working together on a common outcome. How to use it: The RASIC chart illustrates who is responsible and accountable for each step and who is involved in a expert or supportive role. Experience with the RASIC Chart shows that repetition is your friend — meaning that using the same type of roles, and the same processes for communication, coordination and collaboration, allows your team to flow more smoothly from new project to new project in future.

Content level: Intermediate

Learning objectives:

1. Define the RASIC Matrix acronym.
2. Create a RASIC matrix to establish roles and responsibilities with your project team.

Prerequisites: None

Speaker(s): Holly Zink, MSA, Manager of Research Project Development and Education, Children's Mercy Hospital

Research teams are passionate about all of their studies, yet research organizations are responsible for conducting only high-quality research and doing so with limited resources. This presentation will discuss the use of a review and selection process, known as Research Administrative Preauthorization (RAP), used at Aurora Health Care (AHC) to screen studies for merit, compliance, resource needs, and other variables important to a research organization. All research proposals at AHC must be vetted through RAP, thereby allowing the institution to maximize the amount and quality of research conducted by the institution, while also providing oversight by research leadership, guidance from research support teams, and feedback from other researchers. This presentation will provide an overview of the preauthorization process and its purpose, support required for effective administration, lessons learned, and system-wide implementation processes.

Content level: Advanced

Learning objectives:

1. Determine whether research preauthorization would be useful to their organization.
2. Develop a research preauthorization process that is quick and effective.

Prerequisites: None

Speaker(s): Nina Garlie, PhD, Director of Patient-Centered Research for Neuroscience and Emerging Areas, Aurora Health Care

Gene therapy studies are becoming increasingly common as the US FDA (Food and Drug Administration) and other countries have begun issuing approvals for gene therapies, particularly in the field of oncology. Gene therapy studies pose exciting advancements for clinical research but also involve additional risks and regulatory requirements. This presentation will summarize the current state of gene therapy research and the associated risks as well as the evolving regulatory environment in the U.S. Attendees will learn how to obtain the necessary regulatory approvals and prepare sites to conduct gene therapy research.

The presentation will begin by defining gene therapy and summarizing the current state of the field including previous failures, current successes and the emerging regulatory and scientific environment that are resulting in a boom in gene therapy research. The presentation will provide an introduction, intended for non-scientists, to the science of genetic engineering and gene therapy. This portion of the presentation will utilize graphics, videos and refer to major advances covered in the media to illustrate general concepts. The presentation will then detail the risks and associated regulatory hurdles for gene therapy research as well as outlining strategies for obtaining approval to perform gene therapy research at clinical research sites.

Content level: Basic

Learning objectives:

1. Understand what is gene therapy research and the associated federal requirements.
2. Understand how to request approval for gene therapy research.

Prerequisites: None

Speaker(s): Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Director of Biosafety Services, Advarra

This session will discuss real life scenarios the speakers have encountered to illustrate that confidence is a learned skill. The session will also talk about how to use storytelling techniques to develop engaging presentations.

Content level: Basic

Learning objectives:

1. Learn that confidence is a learned skill.
2. Learn storytelling techniques and how they can be applied to presentations.

Prerequisites: None

Speaker(s): Anita Mills, MA, CRA, Senior Solution Consultant, Cayuse & Sikirat A. Tijani, MRA, CRA, Associate Director, Grants and Contracts, Ann & Robert H. Lurie Children's Hospital of Chicago, Office of Sponsored Programs, Stanley Manne Children's Research Institute

Sharing information effectively is a critical skill in the research administration field. We all need to be pushed to think more critically and creatively about communication and presentation as it is necessary to be able to share ideas clearly to grow as leaders. Yet communication and presentation skills and resources are not necessarily top-of-mind when we think about our work. This discussion session will provide a forum for interested and like-minded data enthusiasts at all levels to share a variety of innovative ways to communicate and disseminate data and information to different internal and external stakeholders, curated from leaders in the field.

Content level: Intermediate

Learning objectives:

1. Demonstrate knowledge of best practices in data communication and presentation techniques.
2. Access resources and inspiration for effective communication and presentation of data and results.

Prerequisites: None

Speaker(s): Kimberly Pratt, MA, CRA, Sponsored Projects Officer, The Research Institute at Nationwide Children's Hospital

We will discuss how our institution used its enterprise reporting system, Banner, to track compliance training. By using Banner, the Research Compliance team now documents student and faculty compliance training records, which facilitates reporting of this information across teams in an efficient manner.

Content level: Basic

Learning objectives:

1. Demonstrate knowledge of best practices in data communication and presentation techniques.
2. Access resources and inspiration for effective communication and presentation of data and results.

Prerequisites: None

Speaker(s): Josh Hignight, Manager, Research Compliance; Domenica Pappas, CRA, Director, Office of Sponsored Research and Programs, Illinois Institute of Technology

This session will cover new developments at the National Science Foundation (NSF) - programs, policies, people and budgets. Senior NSF staff will provide a comprehensive review of what is new and developing at NSF.

Content level: Basic

Learning objectives:

1. Learn about the NSF Fiscal Year (FY) 2017 and 2018 budgets and administration priorities for NSF programs.
2. Understand how NSF has implemented recent changes to proposal and award policies and procedures.

Prerequisites: None

Speaker(s): Samantha Brewton Hunter, Senior Policy Specialist, Policy Office, National Science Foundation

We all know that grant awards never quite go according to plan and significant changes are often needed for a project to remain viable after the initial award is made. Some changes definitely require prior approval while others definitely do not, but in many cases the need for NIH prior approval is a definite maybe! This session will address NIH post award prior approval requirements for recipients and explain when you need to contact NIH staff. The presenter will discuss the specific actions that require prior approval and what materials recipients should provide for NIH to review and respond to the request in a timely and efficient manner.

Content level: Basic

Learning objectives:

1. Attendees will be able to identify what actions require prior approval from NIH.
2. Attendees will know what items NIH needs to review and respond to prior approval requests.

Prerequisites: None

Speaker(s): Erik Edgerton, Deputy Chief Grants Management Officer, National Institute of Arthritis and Musculoskeletal and Skin Diseases

Small research administration (RA) offices and RA offices at small institutions often have to meet the same regulatory criteria as larger, research-intensive institutions, but with fewer resources. This presentation will offer some tips and tricks from the trenches, including priority setting, flexibility, partnership with PIs and senior administration, setting boundaries, time management, and tools and other resources.

Content level: Basic

Learning objectives:

1. Participants will understand the role of a manager and learn how to improve on their people skills in the workplace.
2. Participants will learn how to handle difficult people to produce positive outcomes when managing conflict and explore successful strategies for motivating their staff.

Prerequisites: None

Speaker(s): Jane Dumsha, PhD, Chief Research Operations Officer, Philadelphia College of Osteopathic Medicine

This session will discuss issues and tricks related to managing grants from within a department; not a central office. Whether your institution has a central office or not, there are certain things that are just different when you are working on submitting and managing grants from within a department. The session will cover finding funding sources, pre-award submissions and post-award management of grants. The session will also identify additional ways to provide ongoing support for investigators; including trainees, fellows, associates, staff and faculty researchers.

Content level: Intermediate

Learning objectives:

1. Know the differences and similarities between working in a department versus a central office.
2. Learn how to support researchers within a department.

Prerequisites: None

Speaker(s): Kevin Titus, MBA, Business Director, Cincinnati Children's Hospital

The J1 VISA program has very specific expectations that must be met when a visiting scholar is invited to come to the U.S. to study. Your university is essentially inviting a houseguest to come and stay for 12 months. What processes are in place to evaluate the application? Does the hosting department know its responsibilities? What happens when you have to terminate the sponsorship of a J1 VISA? Topics will include:

1. Overview of the J1 VISA program?
2. Requirements & expectations of both the visiting scholar and the sponsoring university.
3. What happens when you have to ask a J1VISA holder to leave?
4. Example set of processes & procedures & lessons learned from terminating a sponsorship.
5. Audience discussion about practices at other institutions.

Content level: Intermediate

Learning objectives:

1. Utilize Kotter's 8-Step Model to lead change in your Department.
2. Identify core skills to build buy-in and collaboration: art of explanation to inspire others to act.

Prerequisites: None

Speaker(s): Becky Hundley, Director of Intellectual Property & Research Compliance, Wichita State University

Our session will focus on the best practices for core/service center development and management. We will start with the setup of a new core including business planning, rate development, compliance, and approval. We will then shift too the core maintenance of the financial management of a core facility. If managed properly all core/service center facilities should be managed in a consistent manner with a high level of service and compliance with the federal regulations.

Content level: Advanced

Learning objectives:

1. Utilize Kotter's 8-Step Model to lead change in your Department.
2. Identify core skills to build buy-in and collaboration: art of explanation to inspire others to act.

Prerequisites: None

Speaker(s): Alex Galea, Associate Administrator, Johns Hopkins University; Kellie Leatherman, Financial Analyst, Johns Hopkins University; Nicole Utech, Senior Financial Manager, Johns Hopkins University

Don’t miss this opportunity to hear about what is new and being developed within the National Institute of Health's (NIH) programs, policies, and budgets. In this comprehensive review, participants will learn about recent policy updates and how their respective institutions may be impacted. Upon completion of the presentation, participants will have the opportunity to ask questions about new and existing policies. Topics include recent and upcoming changes to NIH policy, compliance requirements, and so much more!

Content level: Basic

Learning objectives:

1. Utilize Kotter's 8-Step Model to lead change in your Department.
2. Identify core skills to build buy-in and collaboration: art of explanation to inspire others to act.

Prerequisites: None

Speaker(s): Coming Soon

Close-out does not need to be difficult. Review of roles and responsibilities of each key stakeholder during the close out process. Learn some effective steps to take prior to grant end date to be successful.

Content level: Basic

Learning objectives:

1. Utilize tools for a successful closeout whether they are in a department or centralized office.
2. Understand roles and responsibilities during the process of closing out a grant.

Prerequisites: None

Speaker(s): Jason Claes, MBA, MSM, GRCRA, Assistant Director, Research Accounting, University of Cincinnati

In order to meaningfully evaluate a request to share protected health information with a third party, a reviewer needs information from various sources: the Principal Investigator provides information about data elements to be shared, the human subjects compliance office provides patient authorization information, the data recipient describes how the data will be transmitted, maintained, and used by the recipient, the data security office evaluates the data safety controls, and legal counsel may review the agreement. This presentation explores one academic medical center’s efforts to streamline the process for reviewing requests to share protected health information.

Content level: Intermediate

Learning objectives:

1. Evaluate requests to share data including protected health information of research subjects.
2. Leverage technology solutions to gather information quickly and facilitate prompt evaluation.

Prerequisites: None

Speaker(s): Kristine Martens-Ackeret, JD, Associate Director, Office of Sponsored Programs, Ann & Robert H. Lurie Children's Hosptal of Chicago

This session will lend guidance on how to define allowable, allocable and reasonable costs while adhering to sponsor guidelines, federal regulations and institutional policies. Participants should come ready to discuss, their decision metrics for making the case for allowability. The facilitator and participants will highlight and discuss their own unique situations they’ve encountered in determining allowableness of costs, and discuss the current audit environment and findings as they relate to Uniform Guidance Subpart E: Cost Principles.

Content level: Intermediate

Learning objectives:

1. Describe the four steps that govern direct cost.
2. Provide overview on how to allocate expenditures to sponsored projects appropriately.

Prerequisites: None

Speaker(s): Debra Murray, Assistant Director, Sponsored Programs Accounting and Compliance, University of Maryland; Marchon Jackson, Director of Sponsored Program Accounting and Compliance, University of Maryland

Personnel costs on a grant make project management complex, both during proposal development and post award grant management. Budgeting during proposal development involves many nuances and there can be lots of moving pieces to consider during post award management. Budget execution has its own complexities. This workshop will discuss pre- and post-award methods, complexities, and management, and will include both lecture and hands-on budget development scenarios for various funders.

Content level: Basic

Learning objectives:

1. Understand the many facets of personnel budget development.
2. Identify various personnel considerations when executing the award.

Prerequisites: None

Speaker(s): Rene Hearns, MPA, CRA, Assistant Director-‘IIRECC’/Study Coordinator/Budget Analyst, Louis Stokes Cleveland Department of Veterans Affairs Medical Center; Kate McCormick, CRA, Senior Grants Administrator, Suffolk University

Based upon principles laid out in the NIH’s “Collaboration and Team Science: A Field Guide,” this session is designed for research administrators who work in teams to support research efforts – and that’s all of us! This session will enable participants to identify their strengths profile in the areas of reacting, thinking, and relating, and begin to extend that understanding to other members of the team. Through active participation, we will explore how understanding our own and others’ strengths can help to increase our personal effectiveness and ability to collaborate and strengthen team dynamics in order to meet our ultimate goals.

Content level: Basic

Learning objectives:

1. Learn how your personal strengths impact approaches to problem-solving, communication, and personal interactions.
2. Learn how to create stronger, more inclusive teams by seeking to understand the perspective of all team members.

Prerequisites: None

Speaker(s): Kimberly Pratt, MA, CRA, Sponsored Projects Officer, The Research Institute at Nationwide Children's Hospital

There are a multitude of personal and professional self-assessment tools available to help us better understand ourselves and how we interact with those around us. Increasing our level of self-awareness is critical to our ability to be effective leaders, to make progress on our career goals and improve our work performance--no matter what role we play in our institution. This session will explore some of the available tools, what they can tell us about ourselves, and how this information can be incorporated into our daily interactions to bring about the most positive result.

Content level: Basic

Learning objectives:

Participants will explore tools for assessing their behavior in conflict situations, determining their learning style, identifying their personality preferences, evaluating their emotional intelligence, discovering their influencing style, and learning.

Prerequisites: None

Speaker(s): Tabatha Lemke, Project Manager, Sanford Research; Anne Schauer, MA, CRA, Director of Research and Sponsored Programs Miami University

Accepting a job in a research lab or center can be considered a risky move for most Research Administrators. These positions are often supported by “soft money” and generally report directly to faculty, making them more challenging than traditional departmental positions. However these jobs can be extremely rewarding and are often a unique opportunity to grow your skills as an administrator and become more immersed in the research development process. In this session two senior research administrators will talk about their experiences working in a research development focused environment, including the pros and cons, how they have adapted as administrators over time and why they find these environments highly rewarding. Attendees will leave with an understanding of the different roles Research Administrators often play in these environments and how this alternative service model for structuring research programs could work for them.

Content level: Basic

Learning objectives:

1. Understanding the administrator’s role in a research focused, faculty led environment, along with overall pros and cons of this model.
2. Describe how the model can translate and be successful in a traditional departmental administrative environment.

Prerequisites: None

Speaker(s): Nicholas Prieur, BS, Research Process Senior Manager, Regents of the University of Michigan; Corey Turner, Research Process Manager, University of Michigan; Corey Turner, Research Process Manager, University of Michigan

Kirschstein grants are a large part of the NIH $37 billion dollar (FY2018) grant portfolio. Kirschstein grants provide institutional support for all career stages from undergraduate students to independent researchers preparing to compete for R01s. The purpose of the presentation is to provide a concise summary of the available Kirschstein grants by the intended recipients with a special emphasis on the institutional financial & personnel commitment required to compete for and support these programs.

Content level: Intermediate

Learning objectives:

1. Identify the Kirschstein grants that best suit your organizations available human and institutional resources.
2. Analyze your current professional development program and determine if Kirschstein grants would augment or complement it.

Prerequisites: None

Speaker(s): Beverly Savage, BS, CRA, Research Grants Administrator; Michael Zoffel, BS, CRA, Research Grants Administrator, University of Pittsburgh Learn to solve the Rubix Cube with the easiest method, memorizing only six algorithms.

How does the departmental administrator fit into the flow of research administration? Why is this position important? Join us and learn best practices for being a successful research administrator and mediator between investigators and central research offices.

Content level: Basic

Learning objectives:

1. Develop and Analyze plans for helping PI to meet various deadlines, such as: proposal submissions, monthly reporting, effort reporting, etc..
2. Identify best practices for their role playing as an intermediator between PI's and Central Offices.

Prerequisites: None

Speaker(s): Debra Sokalczuk, CRA, Grants Manager, University of Pennsylvania - SAS-Netter Center for Community Partnerships

We are so focused on large extramural grants, that we often overlook the other sources of research funding, including: philanthropy, foundation grants, research contracts and internal grants. This workshop follows the principal of diversifying your portfolio and looks at these other sources of research funding and the nuances of these opportunities. Participants will take closer looks at these other sources of funding and learn how the better position their institution to not put all their proverbial eggs in one basket. We’ll cover finding the funding, applying for, and managing these different pots of gold. We’ll also cover a variety of different internal funding mechanisms that could be started at your institution; if you don’t already have them.

Content level: Intermediate

Learning objectives:

1. Learn the unique aspects of funding from non-traditional sources.
2. How to seek, find and apply for research funding from sources other than large extramural grants.

Prerequisites: None

Speaker(s): Kevin Titus, MBA, Business Director, Cincinnati Children's Hospital

This session will bring together research administrators from different organization types to discuss how they're managing the Uniform Guidance Procurement regulations that went into effect for many institutions this past year. Speakers will share their policies and tools for implementation. Participants will be encouraged to share their institution's approach to managing these new rules and ask any questions they may have about these new and complex regulations.

Content level: Intermediate

Learning objectives:

1. Describe the procurement requirements set for under Uniform Guidance 2 CFR 200.
2. Understand different strategies for managing these requirements within your organization.

Prerequisites: None

Speaker(s): Dara Little, MPA, CRA, Assistant Vice President for Research and Sponsored Program, Northern Illinois University; Mary Beth Rudofski, Point Consulting; Mark Fehlberg, Executive Director, Procurement Services, University of Chicago

This session will bring together research administrators from different organization types to discuss how they're managing the Uniform Guidance Procurement regulations that went into effect for many institutions this past year. Speakers will share their policies and tools for implementation. Participants will be encouraged to share their institution's approach to managing these new rules and ask any questions they may have about these new and complex regulations.

Content level: Intermediate

Learning objectives:

1. Describe the procurement requirements set for under Uniform Guidance 2 CFR 200.
2. Understand different strategies for managing these requirements within your organization.

Prerequisites: None

Speaker(s): Dara Little, MPA, CRA, Assistant Vice President for Research and Sponsored Program, Northern Illinois University; Mary Beth Rudofski, Point Consulting; Mark Fehlberg, Executive Director, Procurement Services, University of Chicago