Concurrent Sessions

Monday, May 8, 2017 - 9:30am to 10:45am

M102: Swimming with the Big Fish: Mid-Size Institutions Coordinating Large, Multi-Institutional Federal Grants

Central Michigan University (CMU), though a mid-size, Midwestern university, has resources and expertise that are nationally prominent in several important areas of study. CMU has bolstered its strongest programs by hiring cohorts of faculty with complimentary expertise. Often these cohorts and their staff will work collaboratively on sponsored projects, which in turn, include subcontracts with other national experts. The largest of these sponsored projects can become cumbersome to budget and document, involving the coordination of many other university offices of research, departmental administrators, and subrecipient project leaders. Racing to meet deadlines with all of these stakeholders in tow can be an antacid-requiring process, especially with a strong-minded Principal Investigator (PI) at the helm.

During this discussion-based presentation, we will provide details of a large, collaborative, federal award that included a few hiccups along the way. The presenters will share lessons learned from both the pre-award and post-award perspective, before transitioning to group discussion about opportunities and potential pitfalls of multi-institutional project agreements. Presenters will provide participants with case studies and real-world scenarios that involve multiple types of collaborators and partners (businesses, universities, government agencies). Key topics include – best practices for collaborative submissions, essential subaward documentation, and how Uniform Guidance dictates the decision-making process.

Content level: Intermediate

Learning objectives:

  1. Participants will identify the documentation commonly needed for successful collaboration on federal grants and contracts.
  2. Participants will describe and discuss best practice strategies and characterize issues of potential concern when working with multiple entities on a federal grant.

Prerequisites: None

Speaker(s):

Melinda Brakenberry, MPA, CFRA, Manager, Post Award Sponsored Projects and Deborah Clark, BS, MS, Research Officer, Central Michigan University

M104: Defense Advanced Research Projects Agency (DARPA): From Application Submission to Award Management

Applying for and managing Defense Advanced Research Projects Agency (DARPA) awards can be challenging. While DARPA awards many projects to academic institutions and for-profit companies, they are not a well-known sponsor for most research administrators. In this presentation, the speaker will give a brief overview of DARPA, discuss where to find funding opportunities, explain how to respond to DARPA's funding announcements (BAAs) and address key issues to be aware of when managing DARPA grants, cooperative agreements and contracts. The speaker will share his and colleagues' experiences on working with DARPA throughout the proposal submission process, transitioning from a "proposer" to a "performer" during the negotiating phases and working with the sponsor throughout the performance of the project.

Content level: Intermediate

Learning objectives:

  1. Effectively assist principal investigators throughout the application process by understanding the common funding announcement requirements.
  2. Identify key compliance and award management issues, including additional IRB/IACUC requirements and reporting obligations.

Prerequisites: None

Speaker(s):

William Helmrath, MSM, CRA, Grants and Contracts Coordinator, The University of Tennessee Institute of Agriculture

M106: Clinical Research - Breaking Down the Silos

Performing clinical research involves many detailed steps in order for the entire process to be successful. In many cases, there are several vital groups performing these steps who are working independently of each other within the same organization. This presentation will focus on the lifecycle of a clinical trial and the communication it requires to make that clinical trial a success. Even though every clinical trial requires the services of the same groups (i.e. Principal Investigators, Pre-award Office, Post-award Office, Clinical Trial Coordinators, Research Administration, Institutional Review Board (IRB), Quality Assurance), many times these groups have little to no communication with each other during the process, essentially working in silos. It is vital to each clinical trial that these silos are broken down and the teams learn to communicate effectively with one another. This may mean stepping out their comfort zone and learning to understand the different components to the clinical research study. The open communication will give a solid foundation to the clinical trial as everyone will be working together to do their part. During this presentation, specific focus will be given to examples of missed communication opportunities as well as how to break down the barriers and silos. The attendee will be able to use this information in order make the clinical trial process successful for their site performing the research, the sponsor funding the research, and most importantly, for the patient participating in the research.

Certificate: CTRA 101-E

Content level: Basic

Learning objectives:

  1. Increase communication across the different workgroups performing a clinical trial.
  2. Increase the success of the clinical trial for their site, the sponsor funding the research and the patient participating in the research.

Prerequisites: None

Speaker(s):

Melissa Baker, MBA, CRA, Associate Administrator, Research, Nemours Children's Health System

M103: Subrecipient Monitoring: What Is It and When Is It Enough?

The presenter will lay the foundation of what has become known as “subrecipient monitoring” from the days of the Circulars to today having more focus and attention placed on expectations for oversight and monitoring.

Content level: Intermediate

Learning objectives:

  1. Understand the requirements, tools and methodologies associated with Subrecipient monitoring.
  2. Understand how to identify management and technical risk on subawards; Understand how to develop an effective monitoring plan.

Prerequisites: None

Speaker(s):

John Sites, CRA, Manager, Huron Consulting Group

M101: Establishing a Community of Practice to Facilitate Research Administration

This session will focus on how to establish and sustain a community of practice centered around communication and cooperation across university departments and schools to facilitate effective and informed research administration practices. This session will provide a case study example of on-going efforts to establish a community of practice in a large research university. Interactive exercises will allow for audience engagement and discussion of relevant issues. In addition, the session will discuss challenges faced by administrators given seemingly constant changes in policies, procedures, and research personnel. Having this discussion adds value to the practice of research administration because effective communication and collaboration is a growing expectation among research sponsors, researchers, and administrators. Being able to work with and across university departments is an essential practice given strained resources and demands. Single Principal Investigator (PI) projects are becoming scarce and are being replaced by multi-PI, multi-discipline, multi-site projects requiring a high degree of cooperation.

Content level: Basic

Learning objectives:

  1. Identify and describe at least three important elements needed for establishing a community of practice within their institutions.
  2. List three strategies for effective cooperation and communication across departments and schools at their institutions.

Prerequisites: None

Speaker(s):

Jose Alcaine, PhD, MBA, CRA, Research Coordinator, Virginia Commonwealth University

M105: International Case Studies in Research Misconduct

Research integrity is of paramount importance to our institutions and noncompliance with modern Responsible Conduct of Research (RCR) standards can result in severe penalties to the organization, the individual(s), and their reputations. But the modern definition of research misconduct is relatively new, having evolved from hundreds of years of social and ethical issues that have arisen in the practice of scientific research. A review of new and historic cases involving accusations of research misconduct in biology, chemistry, physics and medicine provide some insightful examples of both responsibly and irresponsibly conducted science. What may have been acceptable practice a century ago may be considered unacceptable practice by today’s standards. In this highly interactive session, participants will become familiar with an international case history of research misconduct and will engage in discussion of how these prominent cases have shaped contemporary perspectives on the responsible conduct of research. NOTE: This is a highly interactive session using a wireless audience response system to engage participants, evaluate feedback and formulate group consensus on a variety of ethical issues and questions.

Content level: Intermediate

Learning objectives:

  1. Describe a variety of international cases involving ethical issues in research and apply modern RCR standards to better assess and work through those issues.
  2. Discuss the relevant rules and regulations of modern RCR standards and the ethical principles and cases that justify current institutional compliance policies.

Prerequisites: A basic working knowledge and fundamental understanding of responsible conduct of research.

Speaker(s):

Tony Onofrietti, M.S., CRSS, Director, Research Education, The University of Utah

Monday, May 8, 2017 - 11:00am to 12:15pm

M205: Connecting the Dots of Conflict of Interest (COI) Management and Institutional Review Board (IRB) Administration in Clinical Research

While Conflict of Interest (COI) Management and Institutional Review Board (IRB) Administration may seem to be two different research administration functions, they intersect often within complex COI management plans before, during and after the review of human subject research protocols by the IRB. It is critical that the individuals and organizations with COIs and to the human subjects that participate in research that these research administration functions are closely aligned. This session will highlight the components of managing COIs related to clinical research and how the IRB utilizes this information to ensure quality reviews of protocols. The presenters will address specific concerns and evaluation strategies in managing COIs from both the COI office and the IRB perspectives. The session participants will share their experiences, via anonymous polling and open discussion, related to the management of COIs and their experiences in or with their IRBs.

Content level: Intermediate

Learning objectives:

  1. Identify key overlapping risk factors relative to conflicts of interests and human subjects research.
  2. Analyze organizational approaches to conflict of interest management and IRB administration as two key research administration functions.

Prerequisites: None

Speaker(s):

Adrienne Dumke, MBA, Research Integrity Specialist, University of Louisville and Philip A. Cola, Ph.D., Vice President for Research and Technology Management, University Hospitals Case Medical Center

M203: Recruitment the Money Ball Way: Hiring and Retaining "Diamonds in the Rough"

Vying for the obvious candidate – with flawless grades, glittering resume, and perfectly impeccable appearance – can sometimes lead to frustrations as they are scooped up by competing employers, or worse, accept a position in your office only to (a) receive and accept a “better" offer shortly thereafter, or (b) bring with them a sense of entitlement and unrealistic expectations of a rapid rise through the ranks. Identifying, attracting, and hiring stellar, (but less-obvious), candidates may at times be more advantageous in the long-run – creating cohesive teams and bringing loyal, engaged, and innovative people into the field of research administration. In this session, we’ll discuss recruiting tools, strategies, and approaches for getting a better return on our investment and diversifying our community. Participants will have the opportunity to discuss their experiences with recruitment challenges and share what has worked for them.

Content level: Basic

Learning objectives:

  1. Identify two or more strategies for identifying, attracting, hiring, and retaining stellar entry-level candidates.
  2. Evaluate recruitment and retention tools including interview questions and onboarding plans.

Prerequisites: None

Speaker(s):

Jessica Robins, CRA, Research Advancement Manager, Arizona State University

M201: Discover the Superhero Inside of Every Research Administrator

According to Wikipedia, in modern popular fiction, a superhero is a type of costumed heroic character who possesses supernatural or superhuman powers and who is dedicated to fighting crime, protecting the public and usually battling supervillains. Does that definition sound uncannily familiar to you? Come to this session and explore your extraordinary skills and abilities and find out why being a research administrator is a lot like being a superhero.

Content level: Intermediate

Learning objectives:

  1. Identify the traits and skills of research administrators that match those of superheroes.
  2. Understand what superpowers you should demonstrate in order to be a successful research administrator.

Prerequisites: None

Speaker(s):

Kim Carter, MPA, CRA, CPRA, CFRA, Executive Director, Office of Sponsored Projects Administration, University of Kentucky and Sean Scott, CRA, Assistant Director, University of Kentucky

M204: National Institutes of Health (NIH) Update

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 the newest 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 and procedures.  Topics include recent and upcoming changes to NIH policy, compliance requirements, and so much more!

Content level: Basic

Learning objectives:

  1. Participants will learn about NIH's budget priorities.
  2. Participants will learn about new policies and compliance initiatives.
  3. Participants will gain insight into current issues at NIH.

Prerequisites: None

Speaker(s):

Shellie Wilburn, Special Assistant to the Director, Office of Policy for Extramural Research Administration, OER, National Institutes of Health, HHS

M206: Streamlining Your Clinical Trial Contracting by Using the Accelerated Clinical Trial Agreement

Tired of spending so much time and effort negotiating clinical trial agreements (CTAs)? Join us for the ACTA session to discover a rapidly growing initiative that can eliminate the need for negotiation of Industry Sponsored, Clinical Trial Agreements as well as CTAs for federal subcontracts. Commencing in August 2012, the Master Contracts Working Group consisted of 25 CTSA institutions collaborated with industry and the University Industry Demonstration Partnership to develop a standardized clinical trial agreement - a single agreement to be used (voluntarily) by each participating institution and sponsor, to reduce contract negotiations for industry sponsored multi-site studies Clinical Trials. The ACTA has been finalized with over 275 Institutions agreeing that the ACTA terms would be acceptable to their institution. The Federal Subcontracting CTA agreement has just been finalized and is about to begin rollout.

Certificate: CTRA 201-E

Content level: Intermediate

Learning objectives:

  1. Be more fully informed of the challenges regarding the Clinical Trial contracting processes.
  2. Have an understanding of the development of and process for using the Accelerated Clinical Trial Agreement.

Prerequisites: None

Speaker(s):

Libby Salberg, Director of the Office of Contracts Management, Vanderbilt and Nickie Bruce, Director, Legal Contract Administration, Mayo Clinic

 

M202: Research Administrator’s Forum Eliminates Barriers and Builds Institutional Capacity

Are you ready to forever change the culture and communication between the central sponsored programs and the departmental/college research administrator’s offices? If so, then this is the session for you. Join us as we share a proven methodology that has worked at three educational institutions. We are all faced with daily challenges to meet deadlines and assist faculty with proposal submissions. The central sponsored programs offices and the department/college units have similar challenges. However, we often have competing priorities, and different roles and responsibilities. Frequently, these offices do not see eye-to-eye and this can contribute to research administration dysfunction. In this session, we will discuss a proven format that bridges the communication gap and competing priorities while ensuring that we all stay connected working towards one common goal. The best part is that we accomplish the goal of building research administration capacity and we have FUN in the process!

Content level: Intermediate

Learning objectives:

  1. Learn how a Research Administrator’s Forum Facilitates Communications.
  2. Build institutional capacity through these increased networks and knowledge base.

Prerequisites: None

Speaker(s):

Lynn Asseff, CRA, Director of Operations, College of Engineering & Computer Science; Miriam Campo, Director, Sponsored Programs, Florida Atlantic University; Amber Hardie, CRA, Grants and Contracts Manager, The University of Tennessee, Knoxville and Beth Eslick, Assistant Director, Liberal Arts and Sciences, University of Florida

Monday, May 8, 2017 - 2:15pm to 3:30pm

M306: Letters of Intent, White Papers, Preproposals, Logic Models and Abstracts

Many grant agencies are beginning to require a short preliminary paper before a full proposal can be submitted. These documents serve multiple purposes in funding agencies but sometimes have little detail on how to prepare them. This session will provide definitions of these types of papers, their multiple purposes, and which funding agencies require them. The speaker will offer effective strategies to increase chances of funding success with well-developed short papers that meet agency needs. Agency-specific formats will be illustrated and a template will be provided for use with agencies that do not offer specific instructions.  

Content level: Intermediate

Learning objectives:

  1. List many of the U.S. funding agencies that require these short papers and the multiple purposes they serve in the grant process.
  2. Describe qualities of successful short papers and apply knowledge of these qualities and strategies to help ensure a successful grant.

Prerequisites: None

Speaker(s):

Marjorie Piechowski, PhD, Emerita Director of Research Support, University of Wisconsin-Milwaukee

M302: Doing More with Less

Departmental administrator, what’s that? In the Predominantly Undergraduate Institution (PUI) world departmental administrators are a luxury and often the sponsored projects office acts as the departmental administrator to get the application submitted timely and closed out properly. How does this dual role impact Sponsored Projects Office (SPO) and what can you do? This session will explore options to facilitate pre and post award functions in the PUI environment of “doing more with less.” Are there useful tools to determine how offices should be structured? This session will also explore the pros and cons of having departmental administrators working with a central research administration office. Central Administration: Pre and Post Award together or apart; what are the strengths and weaknesses? Perspectives will include pre -, post- award and departmental administrators.

Content level: Intermediate

Learning objectives:

  1. Strategies to get buy-in from departmental assistants and promote involvement with the SPO; useful tools to assist in structuring an office.
  2. How to develop an infrastructure in a PUI that facilitates pre and post process and identify strategies to evaluate effectiveness.

Prerequisites: None

Speaker(s):

Beverly Morehouse, MBA, Grant and Contract Specialist, Stephen F. Austin State University; Denise Burgan, Research Administrator, Office of Research & Scholarship University of South Florida, USF College of Arts & Sciences and Karen D. Mitchell, MBA, Senior Director, Temple University

M304: Office of Naval Research Agency Update

Overview of the Office of Naval Research (ONR) and current information on awards administered by the ONR Regional Offices.

Content level: Basic

Learning objectives:

TBD

Prerequisites: None

Speaker(s):

Susan B. Kiddoo, Director Office of Naval Research, Atlanta Region

M305: Research Clinical Trial Compliance

This session will explore clinical trial compliance from a good business, financial and clinical practice. We will distinguish what the risks are associated with clinical trials and how to implement process improvement.

Certificate: CTRA 201-R

Content level: Advanced

Learning objectives:

  1. Identify good business, financial and clinical practice goals.
  2. Implementation opportunities for process improvement.

Prerequisites: None

Speaker(s):

Kelly Willenberg, DBA, MBA, BSN, CHRC, CCRP, CHC, Manager, Kelly Willenberg, LLC

M301: Women Leaders in Research Administration: Breaking the Glass Ceiling II (Panel Discussion)

Women who hold senior-level research administration positions can offer their expertise and experiences to those in entry-level or junior leadership roles. Panelist will relay stories of their career journey, along with lessons learned about the importance of strategic career planning, networking, education, and professional development. This session will be highly interactive, in order for the panelists to be able to focus on issues that are most salient to the participants.

Content level: Basic

Learning objectives:

  1. To glean advice from the experience of successful women research administrators and apply the concepts to their own careers.
  2. To challenge themselves to examine their own career priorities and create a plan for the future.

Prerequisites: None

Speaker(s):

Tammy Good, MSM, CRA, CPRA, Associate Director of Finance, CTSI at Indiana University and Sikirat Tijani, MRA, CRA, Associate Director, Grants and Contracts Ann & Robert H. Lurie Children's Hospital of Chicago

M303: Gray is the New Black: Negotiating Uncertainty in Gift vs. Grant Determinations

We all get to collaborate with different departments/offices on campus for the greater good of our research programs. At UNC Charlotte, the sponsored research office met in the middle with the advancement office to work through some of the black and white traditional classifications of gifts vs. grants to establish a working gray model that is not always cut and dry. Together they established the Foundation Proposal Committee and developed a checklist to evaluate each foundation and corporate proposal and turn those gray areas into opportunities to think outside the box.Appalachian State University is starting down this path and opening up discussions with their advancement office to explore new opportunities for collaboration between the two sides of the gift vs. grant debate.We will share real examples from our campuses through case studies and discussion.

Content level: Intermediate

Learning objectives:

  1. Understand one model of how the Advancement Office and Sponsored Research Office collaborate for the good of the University.
  2. Through case studies, learn how to work through the gray areas with the aid of a checklist.

Prerequisites: None

Speaker(s):

Ellen Zavala, Director of Research Services and Outreach, University of North Carolina at Charlotte and Charna K. Howson, Director, Appalachian State University

Monday, May 8, 2017 - 3:45pm to 5:00pm

M403: Anatomy and Psychology of Sponsored Awards

This session is an introduction to award instruments used in sponsored projects and will cover the components of grants, contracts, and cooperative agreements, as well as distinguishing between gifts and awards. Various types of funding sources and methods of awards will be discussed including federal, industry, non-profit and State and local government.

Content level: Basic

Learning objectives:

  1. Determine if funding is a gift or a grant.
  2. Identify the various parts of a grant or contract.

Prerequisites: None

Speaker(s):

Tammy Good, MSM, CRA, CPRA, Assoc Director of Finance, CTSI at Indiana University

M404: Successful Negotiation with Foreign Sponsors: Exploring the Benefits and Understanding the Challenges

This presentation explores how to have a successful negotiation with foreign sponsors. Pulling from 10 years of sponsored project experience, including 4 high volume foreign collaborations, the presenter shares a case study but also dives into exploring the benefits and helps understand the challenges.

Content level: Basic

Learning objectives:

  1. Understand and identify unique challenges in foreign collaborations.
  2. Implement a best practice strategy and plan in working with foreign sponsors.

Prerequisites: None

Speaker(s):

Heather Winters, BS, Director, University of Memphis

M402: Building and Enhancing the Science, Technology, Engineering and Mathematics (STEM) Pipeline

Much recent data on enrollment of U.S. citizens in Science, Technology, Engineering and Mathematics (STEM) disciplines shows a continuing need to enroll women and underrepresented minorities at the undergraduate and graduate levels. However, to increase enrollment of these students it is necessary to have an educational pipeline that prepares highly qualified students to enter college. It is also important to offer robust programs to maintain STEM students through the undergraduate degree and prepare them for further study or to enter the STEM workforce. This session will provide both strategies and funding opportunities to build and sustain a STEM pipeline from middle school through graduate studies.    

Content level: Intermediate

Learning objectives:

  1. Identify a variety of grant opportunities that support STEM education.
  2. Describe strategies to develop a strategic STEM education pipeline at their home institution.

Prerequisites: None

Speaker(s):

Marjorie Piechowski, PhD, Emerita Director of Research Support, University of Wisconsin-Milwaukee

M401: Pre-award Preparation for Post-award Success

Winning a grant award requires preparation at many levels, as does the administration of an award. In this session attendees will learn how to guide the investigator through the in-depth planning required for a successful series of proposals. This includes both scientific and practical preparation such as researching sponsor priorities. On the organization level, preparation and management involves a wide range of compliance issues. Attendees will leave the session with resources for planning and managing proposals and awards. This session will be most useful for newcomers to research administration and administrators at smaller institutions.

Content level: Basic

Learning objectives:

  1. Knowledge of the many levels of investigator and institutional compliance.
  2. A framework for guiding investigators to successful proposal activities.

Prerequisites: None

Speaker(s):

Kathryn Watkins, Med, Assistant Vice President, Research Admin, The University of Akron and Heather Kraus, Senior Manager for Research Administration, University of Michigan

M406: Clinical Trial Budget Negotiation Challenges: It's Your Cost of Doing Business

Clinical trial budgets are always negotiable. Still, many investigators and clinical teams accept original budgets proposed by industry sponsors. The process of budgetary negotiation may seem intimidating, overwhelming, or ungrateful. In reality, negotiation allows both the sponsor and the site to arrive at a consensus which will benefit both sides. With an acceptable budget the site is more likely to fully commit to subject enrollment and site compliance by allocating proper resources and effort, which will result in producing higher quality data. Trial success can be easily compromised when budgets are negotiated poorly or accepted with no negotiation at all. Who is the right negotiator at the site level? How to muster sufficient negotiation power? When to push back and what to forgo? These and other questions will be addressed in the course of the session. The participants will discuss practical negotiation tips and techniques. Actual budget negotiation examples will be used to reveal most common stumbling blocks between sites and sponsors and the ways to circumvent them.

Certificate: CTRA 201-R

Content level: Intermediate

Learning objectives:

  1. Utilize various budget negotiation tips and techniques.
  2. Define the role of budget negotiation in trial success.

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business Operations, Clinical Trials Office and Vanessa Bryant, Sr. Budget Analyst,  Clinical Trials Office, University of Utah

M405: Food and Drug Administration (FDA) Oversight Introduction for Social, Behavioral and Educational Research (SBER) Institutional Review Boards (IRBs)

Institutional Review Boards (IRBs) who are primarily Social/Behavioral/Educational research focused sometimes find themselves reviewing research involving drugs, dietary supplements, devices, food, and apps that may require Food and Drug Administration (FDA) oversight. This presentation provide basic guidance for determining when FDA oversight may be applicable.

Content level: Basic

Learning objectives:

  1. Identify potential areas when FDA regulations may apply to a research protocol.
  2. Understand the IRB's and IRB Office's roles when FDA regulations may apply.

Prerequisites: None

Speaker(s):

Robin Tyndall, Director, Office of Research Protections, Appalachian State University

Tuesday, May 9, 2017 - 8:30am to 9:00am

R4: Handling Information Overload: Stress Management for the Busy Research Administrator

Are you constantly adding items to your to-do list and it seems like your list never shrinks? Are you feeling overwhelmed at work and at home? As a research administrator, you’re constantly being bombarded with information from every angle. From emails to social media to organizational meetings, it’s sometimes hard to separate what’s really important. During this discussion we will explore the signs and symptoms of stress and strategies and techniques to overcome information overload, boost productivity and cope and reduce stress.

Content level: Basic

Learning objectives:

  1. Identify what are the signs and symptoms of stress.
  2. Identify examples of actions and strategies to cope with stress and prevent full-blown burnout.

Prerequisites: None

Speaker(s):

Christy Taylor Bray,  Assistant Director, Research Training and Development, Research Services, The University of Texas Medical Branch at Galveston

R5: How a Research Nursing School Revised Its Culture of Research

Discussion of how one school re-vitalized their culture of research and significantly increased awarded grants.
Share ideas on how your institution encourages and supports grant submissions.

Content level: Intermediate

Learning objectives:

  1. List activities taken to increase the submission of research grants.
  2. Identify the barriers to these activities and how an institution might overcome these barriers to succeed.

Prerequisites: None

Speaker(s):

Margaret Roudebush, MNO, Assistant Dean of Research Administration, CWRU

R6: Organizational Resilience: How to Build and Sustain a Strong Office

Organizational Resilience is defined as “the ability of an organization to anticipate, prepare for, respond and adapt to incremental change and sudden disruptions in order to survive and prosper." In times of  unanticipated big changes such as a change in leadership or catastrophic events such as loss of accreditation, non-compliance or scandal, it may be all a leader can do to get the day to day work out the door. Preparing for the inevitable if not unexpected will help to sustain an organization even through the darkest of times.

Content level: Advanced

Learning objectives:

  1. Develop strategic planning goals that provide for sustainability and gaps in staffing.
  2. Be better prepared to provide stability through otherwise troubling times.

Prerequisites: None

Speaker(s):

Susan Sedwick, PhD, CRA, CSM, Consulting Associate, Attain LLC and Michele Vaughan, BS, CCRP, Director, Clinical Research Operations for Hem/Onc/BMT Director, NEXT Consortium

R2: Position Filled: 10 Things Every New Sponsored Program Administration (SPA) Should Know

Sponsored Programs offices frequently hire people with no experience in sponsored programs or working with researchers. This can be challenging for both the new employee, the manager and the researchers. In addition to teaching new employees how to do their job, it is equally important to provide mentorship in order to better acclimate them in the realm of sponsored programs in a research setting especially in higher education. Communicating appropriately with their audience (faculty, staff, National Institutes of Health, etc), why the federal standard dates calendar dictates their schedule, the importance of university policies and procedures, and why an open­door policy is critical are a few of the several topics that will be presented. It is critical that employees new to a sponsored programs have a solid foundation and positive training experience. The value for research administration is this information can help develop and keep new sponsored programs administrators. Group discussion and activities will be used to help participants share experiences and achieve learning objectives.

Content level: Basic

Learning objectives:

  1. Increase understanding of challenges faced by new sponsored programs employees.
  2. Analyze training programs to improve new sponsored programs employees training.

Prerequisites: None

Speaker(s):

Beth Durak, Senior Managing Research Administrator, Boston University

R8: Calculating Exact Effort for Research Staff Conducting Clinical Trials

At the University of Wisconsin (UW), Clinical Research Coordinator's (CRC's) salaries are typically paid from funded grants or awards in the value or percentage regarding the effort they are proposed to spend working on each clinical trial or project. The challenge with this is that biannually, coordinators are expected to certify this effort. Unfortunately, the exact effort of each CRC is often not accurately applied to the appropriate clinical trials, presenting a scenario in which effort would need to be corrected by salary cost transfers before certification could occur. In order to correct effort on projects, the Accounting office and the Effort Coordinator were often tasked with multiple time-consuming salary cost transfers as well as impending effort certification deadlines. In this presentation, I will demonstrate how UW's Department of Surgery created a system to track the exact effort of CRCs in real-time and to monthly bill each clinical trial/project for real-time effort. The system is composed of a few individual parts. Primarily, the Accounting office set up a revenue producing account (RPA)/pool account in which all of our CRC's salaries are paid from. Each business day, the CRC utilizes a time-tracking program to measure in real-time, the individual clinical trials/projects that they are working on. At month end, each coordinator exports an individual report from the time-tracking program which graphs out the exact effort in hours spent on each individual project. For the Office of Clinical Research (OCR), I developed a calculated fee schedule that captures CRC salary average, fringe rate, paid time off (PTO), administrative costs, and travel stipends in order to calculate an hourly rate for study coordination. (For UW, this is $50/hour.) Using the monthly, number of hours spent on a project multiplied by the CRC hourly fee, each individual clinical trial account is billed to transfer the exact amount back to our RPA/pool account. The effort that CRCs track in a study's activation period (before the individual trial account is set-up) is off-set by the direct cost of the Sponsor's study activation fee also being deposited into the pool account. This system eliminates the need for CRCs to certify effort on any of our funded projects and for OCR to monitor the average amount of CRC effort that should be captured in current and future clinical trial budgets. Another benefit of this system is that we have increased communication and transparency with our faculty/Principal Investigators (PIs) through quarterly financial meetings in which they can assess the monthly effort billed to their clinical trials for accuracy. OCR has been utilizing this new system since July 2015 and it has improved the way we analyze projects in regards to CRC effort, budgeting, and CRC time management and task prioritization. OCR has also shared this concept with other research offices within UW and other departments and offices are beginning to implement this system.                                                                            

Content level: Intermediate

Learning objectives:

  1. Conceptualize an example of a system that may assist your institution/clinic in managing CRC effort and salary compensation ensuring integrity to your sponsors.
  2. Create an environment of financial transparency with Principal Investigators/Faculty overseeing the conduction of clinical research and also to use this tool to improve the accuracy of clinical research budgets in the future.

Prerequisites: None

Speaker(s):

Lisa Werning, BS, Director of Clinical Research, Department of Surgery, University of Wisconsin-Madison and Ann Collura, Clinical Trials Accountant, Department of Surgery, University of Wisconsin-Madison

R1: Working with the Institutional Review Board (IRB) on Review of Contracts, Data Use Agreements (DUAs) and Material Transfer Agreements (MTAs)

Discussion about how the Office of Sponsored Programs and Institutional Review Board (IRB) at Children's have worked together to build a more robust review of Contracts, Data Use Agreements and Material Transfer Agreements by identifying areas of concern for each department. Provide examples of issues we have encountered and averted. Open the conversation to learn how other attendees work with various departments for a more thorough review of contracts.

Content level: Basic

Learning objectives:

  1. Identify areas where the IRB can provide assistance in review Contracts, DUAs and MTAs.
  2. Identify potential issues that OSP might be able to identify for the IRB.

Prerequisites: None

Speaker(s):

Sarah Marie Huban, MA, CIP, CHRC, Manager, HPP and Research Regulatory Affairs and Shanta Laurie, Manager, Office of Sponsored Programs, Children's Healthcare of Atlanta

R7: Grants Management in a Department/Division

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: Basic

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

Tuesday, May 9, 2017 - 9:15am to 10:30am

T105: Financial Conflicts of Interest in Research

I propose to deliver an interactive presentation focusing on financial conflicts of interest in research. I propose to take a particular look at conflicts of interest that may arise as a result of outside consulting activities by research principal investigators. The importance of compliance with National Institute of Health and National Science Foundation financial conflict of interest rules will be stressed.

Content level: Basic

Learning objectives:

  1. Understand and comply with financial conflict of interest rules put in place by federal research sponsors.
  2. Understand the importance of avoiding financial conflicts of interest arising from outside consulting activities of research principal investigators.

Prerequisites: None

Speaker(s):

John Cates, JD, Chief University Counsel, University of Alabama System

T103: Big Bang Theory: Truth Is Stranger Than Fiction

If you are a fan of the Big Bang Theory and relate to the situations that arise on the show, you will enjoy this interactive session that uses vignettes from the show to offer case studies in actual dilemmas faced in research administration offices. Your office may not have dealt with a smoking monkey being housed in someone's apartment or all data from the Mars Rover being mysteriously lost but the fictional situations may be closer to the truth than you think.

Content level: Intermediate

Learning objectives:

  1. Identify strategies for dealing with exceptional faculty.
  2. Find consolation that you are not alone in dealing with things that really should not happen.

Prerequisites: None

Speaker(s):

Susan Sedwick, PhD, CRA, CSM, Consulting Associate, Attain LLC

T102: Motivating Reluctant, Inactive or Inexperienced Investigators to Pursue Grants

In recent years competition for grants has greatly intensified for many reasons, causing investigators at all career levels to become reluctant, discouraged or inactive in seeking support for their research. New investigators face their own challenges in getting that first award. This session will offer an overview of characteristics of reluctant, inactive, inexperienced or discouraged investigators that deter them from pursuing grant funding. Based on a literature review and best practices, an array of strategies and solutions will be offered, including incentives, mentoring, partnering, targeted workshops, and individual strategic plans for research funding. Participants will be encouraged to share examples and case studies of their own best practices for motivating and working with these investigators. The session will be interactive and participatory for research administrators (proposal developers) from all types of institutions.

Content level: Intermediate

Learning objectives:

  1. Describe characteristics of inactive researchers at all career levels.
  2. List an array of strategies to encourage grant participation from faculty members at all academic levels.

Prerequisites: None

Speaker(s):

Marjorie Piechowski, PhD, Emerita Director of Research Support, University of Wisconsin-Milwaukee

T106: Understanding and Successfully Managing a Clinical Trial

The sponsored research portfolio at many large institutions now includes a sizable number of clinical trials whose management is very different from managing basic research project portfolios. In order to effectively manage these complex projects it is important that the research administration team understand all aspects of the clinical trial. In this session we will review the cycle of a clinical trial for both federally funded and industry sponsored clinical research. We will review what a clinical trial is, the different types of clinical trials, Food and Drug Administration (FDA)  trial regulations and the Institutional Review Board (IRB) process before focusing in-depth on the financial management of a clinical trial. Financial management topics covered will include: the contract review process and what to look for in terms and conditions, how to conduct a comprehensive protocol review and identify hidden costs, and the best strategies to develop a robust and accurate budget. We will also cover the key aspects for accurate invoicing and payment recovery. An example of a clinical trial will be used to demonstrate the process.

Certificate: CTRA 101-E

Content level: Basic

Learning objectives:

  1. Participants will learn the key elements of a clinical trial.
  2. Participants will learn how to develop and manage clinical trial budgets.

Prerequisites: None

Speaker(s):

Rashmi Pershad, M. Phil, Associate Research Administrator and Meagan A. Sok, MPH., Research Administrator, Virginia Commonwealth University

T104: Property Administration, What in the World are We Looking for?

This presentation provides the listener with a good idea by Property Management Outcome Area what an auditor is looking for regarding, records and compliance.

Content level: Basic

Learning objectives:

  1. Understand specific things a Property Administrator is reviewing their property system for compliance.
  2. Audit expectations, assisting them with both system compliance and audit readiness.

Prerequisites: None

Speaker(s):

Tracy Helmick, Industrial Property Officer (IPO), NASA

T101: Social Media in Research Administration #bestpractices #notsoscary

Does the thought of using Twitter for work strike fear in your heart? Have you only used social media for sharing cat pictures and political memes? Is social media a new part of your job, and you don’t even know where to begin? If so, this presentation is for you! Through real life examples from two large research programs at the University of Michigan, we will provide participants with a beginners guide to implementing a social media presence for your research program and faculty. Participants will review the importance and benefits of social media in research dissemination, discuss steps and best practices for creating a social media presence, learn ways to find and generate creative content, and will address and troubleshoot challenges in the process.

Content level: Basic

Learning objectives:

  1. List basic steps to take before creating a social media presence.
  2. Identify creative ways to access and share content.

Prerequisites: None

Speaker(s):

Nicholas Prieur, Research Process Manager and Amanda Donovan, Project Coordinator, The University of Michigan

Tuesday, May 9, 2017 - 10:45am to 12:00pm

T202: Contracts 101

The landscape of sponsored projects is becoming increasingly complex, extremely competitive and difficult to maneuver. This session provides a high level, introductory overview into the world of contracts by comparing and contrasting the differences between a grant and a contract. The presentation details the differences between the two by breaking down the federal definitions and regulations. Participants will also gain an understanding of the Federal Acquisition Regulation (FAR) structure and basic contracting processes as well as the differences in compliance, budgeting and reporting. Attendees will also learn about the different types of contracts and the varying risks associated with contract terms and conditions.    

Content level: Basic

Learning objectives:

  1. Identify and understand the differences between a contract, grant and gift.  Become familiar with the bid solicitation process and to distinguish between a cost/technical proposal. 
  2. Understand the structure of the FAR and how/when it's used as well as identify and understand FAR clauses in RFP's and which impact post-award administration.

Prerequisites: None

Speaker(s):

Heather Winters, BS, Director, OSP, University of Memphis and Angela Fair, Associate Director, Office of Sponsored Programs, University of Memphis - USA

T205: Defining and Streamlining Review of Reportable Events: A Practical Approach

This session will provide attendees with an overview of various types of events that occur in research which may require reporting to Institutional Review Boards (IRBs). We will discuss a streamlined process for IRB investigation and review of reportable events and discuss of two different options for full board review of reportable events. The session will include case examples of reportable events.

Content level: Basic

Learning objectives:

  1. Define different types of reportable events: AEs, SAEs, UPs, NC, SNC, CNC.
  2. Identify strategies for streamlining review of reportable events.

Prerequisites: None

Speaker(s):

Sarah Marie Huban, MA, CIP, CHRC, Manager, HPP and Research Regulatory Affairs and Emily Smotherman, Manager of Research Compliance, Children's Healthcare of Atlanta

T203: Using Philanthropy to Support Research

This session will identify and describe the benefits and important differences in securing and using philanthropic gifts to support research. Hear from an experienced fundraiser, and research administrator, how to secure millions in gifts to support important research. We will review simple steps to foster an environment of gift-supported research at your institution; large or small. Learn how to cultivate new and existing donors and how to partner philanthropic funding opportunities with research priorities. We will discuss engaging your faculty, physicians and other staff in philanthropy. Guidelines for distinguishing between gifts and grants will also be shared. Unless your research program is blessed with a fully-funded endowment producing perpetual income sufficient to sustain and grow your research or you’re 100% confident you will be fully funded by the government, then you need to attend this session. This practical session will provide tips to use right away and in the long-term.

Content level: Intermediate

Learning objectives:

  1. Understand how to link and support research needs with philanthropic opportunities.
  2. Understand the practical distinction between a sponsored program grant and a philanthropic gift.

Prerequisites: None

Speaker(s):

Kevin Titus, MBA, Business Director, Cincinnati Children's Hospital

T201: What I Wish I Knew When I Started Working in Research Administration

This would be a panel comprised of Research Administrators and Departmental Administrators discussing their career successes and pitfalls. The panelists would vary in their years of experience, meaning some would have been in their roles 2-5 years, 5-10 years, and 10-15 years.  Each panelist would share stories of how the pitfalls they have experienced made them successful in their careers or possibly pushed them into another direction in their career path. 

Content level: Basic

Learning objectives:

  1. Learn from the pitfalls of more experienced Administrators and use this information as a guide when confronting one's own pitfalls.
  2. Build a network from experienced Administrators.

Prerequisites: None

Speaker(s):

Kia Reaves, MBA, CRA, Administrative Officer for Research and Doris Head, CRA, Administrative Officer, Department of Medicine Admin, Vanderbilt University Medical Center

T204: National Science Foundation (NSF) Update

This session will cover new developments at 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:

TBD

Prerequisites: None

Speaker(s):

Jean Feldman, Head, Policy Office, National Science Foundation

T206: Clinical Trials: The Measurement of Success-Screening, Enrollment, Follow-up and Financials

In this presentation, Lisa and Ann will demonstrate a Microsoft Excel tool that the University of Wisconsin-Madison, Department of Surgery-Office of Clinical Research created and utilizes to monitor all industry-sponsored clinical trials for screening, enrollment, follow-up, financials, and activation status of new research. We will also speak briefly about feasibility and identification of target enrollment for a study and how UW determines this early in the activation process.

Certificate: CTRA 101-E

Content level: Basic

Learning objectives:

  1. Evaluate the different aspects of their own clinical trials programs in regards to meeting screening and target enrollment goals.
  2. Analyze how screening and enrollment efforts are related to financial and residual status of the project.

Prerequisites: None

Speaker(s):

Lisa Werning, BS, Director of Clinical Research, Department of Surgery and Ann Collura, Clinical Trials Accountant, Department of Surgery, University of Wisconsin-Madison

Tuesday, May 9, 2017 - 1:45pm to 3:00pm

T302: Post-Submission to Award Acceptance

The pre-award office is responsible for dealing with a variety of issues that arise after proposal submission and lead to acceptance of the award. The pre-award administrator should be able to deal with publication restrictions, intellectual property, indemnification, facilities and administrative costs questions, and know how to address such special situations as international agreements and JIT requirements. The session will identify troublesome clauses and discuss how to determine what to accept and what to reject, and other difficult contract review topics.

Certificate: PA-R

Content level: Basic

Learning objectives:

  1. Review different types of award terms and conditions, including Federal Acquisition Regulations and different grants policy manuals.
  2. Negotiate acceptance of awards.

Prerequisites: None

Speaker(s):

Beverly Maddox, Director of Reseach Administration, College of Health and Human Services, Kennesaw State University and Charna Howson, Director, Sponsored Programs, Appalachian State University

T304: Data and Privacy

We all live in a world of digital data, generating an information trail as we e-mail and study, conduct research, use health care, shop with loyalty cards, and make wireless calls. In response, individuals and watchdog groups are raising alarms about the Orwellian implications and government agencies are increasing regulation and instituting severe punishment for privacy infractions. In Europe and the United States, elaborate bodies of law as well as a structure of non-legislative rules and regulations  have formed around privacy issues. Computer technology, and increasingly biotechnology (e.g., genetic information gathering) is getting ever more powerful and sophisticated and the issues of digital privacy and disclosure of personal information is rapidly coming to the fore.

Content level: Basic

Learning objectives:

  1. Identify the privacy issues that arise in the research enterprise and the steps governments taking to regulate and control research activities use of personal information and development of technology that can invade privacy and that can protect individuals from identification or location?
  2. Examine the laws and regulations that most affect the compilation and use of personal, private, and confidential information in research and resulting from research, treatment and education.

Prerequisites: None

Speaker(s):

Michael Slocum, President, Slocum & Boddie, PC, Alexandria, Virginia

T305: Building Responsible Conduct of Research Training Programs at Predominantly Undergraduate Institutions (PUIs)

Responsible Conduct of Research (RCR) training programs are required of institutions receiving funding for certain types of grants from the National Institutes of Health (NIH) and the National Science Foundation (NSF). Predominantly Undergraduate Institutions (PUI) often have unique challenges in contrast to larger higher education research universities in complying with these regulations. What strategies can the research administrator apply to design effective RCR education plans? What policies will enhance the “culture of compliance” at the PUI? In this highly interactive session, different institutional perspectives and best practices for developing, implementing and documenting effective RCR training programs and policies for faculty, staff and students at PUIs will be presented.

Content level: Intermediate

Learning objectives:

  1. Attendees will gain an understanding of a variety of proven techniques for delivering effective responsible conduct of research (RCR) training programs and policies at PUIs.
  2. Attendees will learn how to design an effective RCR training plan utilizing different instructional methods to enhance teaching and learning effectiveness.

Prerequisites: A basic working knowledge and fundamental understanding of responsible conduct of research.

Speaker(s):

Tony Onofrietti, M.S., CRSS, Director, Research Education, The University of Utah

T306: Clinical Trials: The Industry Perspective

This is a presentation of the process of drug development from the pharmaceutical industry’s perspective Timelines, quality and cost will be driving factors for discussion. The pharmaceutical industry’s general organizational structure will be introduced. The clinical trial protocol development process and clinical study conduct will be presented. Pharmaceutical drivers for study site selection will be highlighted. Site-based contracts, including budgets, publication rights and intellectual property will also be discussed.

Content level: Basic

Learning objectives:

  1. Understand the drug development process including pharmaceutical industry drivers.
  2. Understand how sites are selected and contracts are negotiated for clinical trials.

Prerequisites: None

Speaker(s):

 Maria Soliman, Director, LCI Research Administration, Carolinas HealthCare System

T303: Research Financial Projections Using Algorithms and Probabilities

Michigan Technological University created a research financial projection model tool (ASPIRE) using its financial index open balances, pending proposals and anticipated awards.  It allows the campus community (deans,chairs,and administrators) to summarize its projected annual research expenditures, indirect cost recovery (net of cost share) and its incentive returns the through the life of the project. It has opened the gates for better financial planning while eliminating shadow systems.  The projections data is pulled from two University databases: Banner (financial/post-award) and TechTracS (pre-award).  Forecasting the pending proposal and anticipated awards is computed using 3 year rolling average success rates based on two criteria—the success of both the department and the size/amount of research proposal.  A monthly expenditure algorithm is then applied to project future fiscal years. This tool is available upon demand and provides valuable insight to the campus community.

Content level: Advanced

Learning objectives:

  1. Calculate/forecast your institution’s projected annual expenditures, indirect cost recovery (net of cost share) and incentive returns.  Michigan Technological University will share its best practices.
  2. Leverage this information for other institutional analyzing needs, e.g. budgeting or space optimization planning.

Prerequisites: None

Speaker(s):

Michael Hendricks, Director, Institutional Systems Development & Analysis and Gina LeMay, Director of Sponsored Operations & Information Systems, Michigan Technological University

T301: Generation "THEM": Navigating a Multi-Generational Workforce

Administrators often finding themselves closing their doors and rolling their eyes at their employees "tattling" on the other generations. Everyone seems to believe that their way is the best way. The problem? Often ALL of their ways have merit. This presentation explores the differences in the three primary generations in them American workforce and the "rules" of the Traditionalist that no longer feel relevant to much of its employees. From your boardroom to your thanksgiving table you'll find this information valuable in all facets of your life.

Content level: Intermediate

Learning objectives:

  1. State norms and values of each generation in the American workplace.
  2. Describe techniques used that can be used to motivate individuals in each generation.

Prerequisites: None

Speaker(s):

Kristin Scroggin, Masters Communication Studies, Professional Trainer, Workplaces Training Solutions

Tuesday, May 9, 2017 - 3:15pm to 4:30pm

T403: Research Terms and Conditions

This session will describe the changes to the Research Terms and Conditions that implement the Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards (2 CFR § 200).

Certificate: CTRA 101-E

Content level: Basic

Learning objectives:

  1. Understand how the revised set of Research Terms and Conditions were conceived.
  2. Learn how agencies will implement the revised Terms and Conditions.

Prerequisites: None

Speaker(s):

Jean Feldman, Head, Policy Office, National Science Foundation

T401: Training for Mastery: Michigan's Move to Experiential Training for Research Administrators

This session will share the steps to training program overhaul taken by the University of Michigan in developing "Navigate: Fundamentals", a training program for new research administrators which addresses the full range of learning objectives in pre-award and post-award administration to individuals developing proposals and managing research activities in units. Included in this presentation will share how this large public institution conducted training needs analyses, developed full spectrum learning objectives, and engaged in design and development of an experiential curriculum where learners will see, do, and practice concepts taught to assure job readiness in this growing field. Also shared are training development and design activities begun in Experiential Advanced Budget, Uniform Guidance, and more...

Content level: Intermediate

Learning objectives:

  1. Identify the steps needed to assess current training programs in research administration and identify gaps in learner needs.
  2. Utilize a framework for training development in research administration for their own organizations, with emphasis on development of programs offering immersive, experiential learning for mastery.

Prerequisites: None

Speaker(s):

Yvonne Sturt, Assistant Director, Office of Research and Sponsored Programs, University of Michigan and Catherine Seay-Ostrowski, MA, SPHR, Business Administrator Staff Specialist, University of Michigan Biomedical Engineering

T404: Capitated Budgets: Post-award Financial Management of Fixed-price Clinical Contracts

How does managing a fixed-price clinical trial contract differ from a cost reimbursable grant? Even for financial administrators experienced in post-award grant management, capitated budgets may present a challenge. Fixed-price contracts may require a shift in one's perception of and established standards for effort allocation, project periods, budgetary line items, billing procedures, and reconciliation processes. The concepts of flexible budgets, amendable budgets, milestone reimbursements, negotiations with sponsors, flat fees, competitive enrollment, charges vs. costs become a new reality. Recent years show that even National Institutes of Health (NIH) funding is gradually shifting to capitated reimbursement structure for clinical research proposals. In this session participants will utilize sample clinical trial contracts and financial tools to address the differences between fixed-price and cost-reimbursable projects as well as the post-award challenges and the benefits of capitated contracts.

Certificate: CTRA 201-E

Content level: Intermediate

Learning objectives:

  1. Define main differences in post-award management of fixed-price contracts and cost-reimbursable grants.
  2. Utilize practical skills in post-award financial management of capitated clinical trial contracts.

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business Operations, Clinical Trials Office and Vanessa Bryant, Sr. Budget Analyst, Clinical Trials Office, University of Utah

T406: How Can a Financial Navigator Help Your Clinical Patients

How can a financial navigator help clinical trial patients at your site.  A financial navigator is a newer concept to clinical trials.  This role can be utilized to help clinical trial patients understand and navigate the complex world of financials related to trials.  This presentation will outline the role of the position, ways to improve communication with the patient, how to help the clinical trials office and more.

Content level: Intermediate

Learning objectives:

  1. How can a financial navigator help your clinical trials program.
  2. Outline roles and responsibilities of the position.

Prerequisites: None

Speaker(s):

Maria Soliman, Director, LCI Research Administration, Carolinas HealthCare System

T402: Electronic Research Administration

The presentation will look at how electronic Research Administration (eRA) has changed the practices and procedures at research institutions. It will detail what issues can arise from utilizing electronic systems and provide a discussion of best business practices in dealing with eRA issues.

Certificate: PA-R

Content level: Intermediate

Learning objectives:

  1. Understand what issues can arise from using eRA systems.
  2. Understand what can be done to mitigate eRA issues at their institutions.

Prerequisites: None

Speaker(s):

Sean Scott, CRA, Assistant Director, University of Kentucky

T405: Singing from the Same Sheet: Effective Communications between Sponsored Programs and Research Compliance

Conflict of interest, human subjects, animals, biohazards & radioactive materials, export controls..... How does a research administrator sleep at night while managing multiyear projects?  It takes team work and coordinated efforts with planned followups and reviews, standard operating procedures, and policies that govern next steps when things go wrong.

Content level: Basic

Learning objectives:

TBD

Prerequisites: None

Speaker(s):

Charna Howson, Director, Sponsored Programs; Amy Roberts, CRA,  Director of Special Funds and Robin Tyndall, Director, Office of Research Protections, Appalachian State University

Wednesday, May 10, 2017 - 9:00am to 10:15am

W104: Cybersecurity Compliance for Department of Defense (DoD) Contractors: Making sense of Defense Federal Acquisition Regulation Supplement (DFARS)

Please join us to discuss compliance focusing on Defense Federal Acquisition Regulation Supplement (DFARS) clause 252.204-7012. Compliance with the 110 controls is due at the end of 2017. We will go over the controls at a high level and highlight the top 5 controls. We will also discuss the history of DFARS compliance and what non-compliance means for the contractor.

Content level: Intermediate

Learning objectives:

  1. At a high level, understand the breadth of security requirements that DoD contractors must be compliant with by the end of 2017.
  2. Determine if they need to be concerned with these requirements.

Prerequisites: None

Speaker(s):

Drew Hollander, M.Eng., Senior Cyber Engineer, DESE Research and Adam Maddox, Chief Technology Officer, H2L Solutions

W102: Dysfunctional Workplace or You? How Do You Spell RELIEF?

We spend so much of our lives in the workplace. The right setting can make even a tedious job something to look forward to, but there are many workplaces that suffer from some degree of dysfunction, which can lead to unhealthy levels of stress. Can you identify the root cause of dysfunction in your workplace? Is it your boss, a colleague, co-worker, stakeholder, or is it YOU? Is your work environment dysfunctional, or just a normal stressful work environment? Understanding an unhealthy work environment can lead to negative stress and what you can do to stop the downward spiral.

Content level: Basic

Learning objectives:

  1. Look at healthy habits to adopt and practice, on minimizing stress and improving relationships within your organizations.
  2. Understand that “one size does not fit all.”

Prerequisites: None

Speaker(s):

Gloria Greene, MA, CRA, Director, Office of Sponsored Programs and Laurel Long, Associate VP for Human Resources, The University of Alabama in Huntsville

W105: Negotiating Clinical Trial Agreements with For-Profit Companies

This session includes a basic introduction to the process of negotiating with for-profit companies. It will also include strategies on avoiding pitfalls in budgetary and non-budgetary contract terms. The primary objectives are:

1) Identify Primary Differences Between For-Profit Agreements vs. Non-Profit Agreements
2) Negotiate Common Areas of Conflict
3) Review Budget Items and Payment Terms

Certificate: CTRA 101-R

Content level: Basic

Learning objectives:

  1. Identify Primary Differences Between For-Profit Agreements vs. Non-Profit Agreements.
  2. Negotiate Common Areas of Conflict.

Prerequisites: None

Speaker(s):

Vanessa Bryant, Sr. Budget Analyst, Clinical Trials Office and Tara Merrill, Contracts Officer, University of Utah

W101: Coaching to Drive Performance

You’ve probably asking yourself, ”How can I make sure I’m as effective as I can be? How do I get results when the role of leader keeps changing?“ Our jobs are changing all the time and there is more to be done and fewer employees to get things done. Some of the keys to leadership effectiveness today are coaching and mentoring. You need expert coaching techniques to ensure that your team members know their positions, fully devote their talents to the task at hand and support their teammates. This session is designed for any person in a role that leads and influences other's performance, desiring to further hone their coaching skills to bring out the full potential in others.

Content level: Basic

Learning objectives:

  1. Create an environment of caring and cooperation that inspires people to go the extra mile. 
  2. Provide effective feedback and assess progress towards goals and sustaining improved performance.

Prerequisites: None

Speaker(s):

Christy Taylor Bray, Assistant Director, Research Training and Development, Research Services, The University of Texas Medical Branch at Galveston

W103: Subaward Risk Assessment and Monitoring

Uniform Guidance (2 CFR 200) brought increased emphasis on proactive and effective management of subrecipients and subawards and has focused our attention on best practices for risk assessment of subrecipients, inclusion of additional terms in subaward agreements to minimize the risks to our institutions and post-award monitoring of subaward expenditures and performance. Let's get together and share our common challenges and the solutions we have found to improve processes and compliance.

Content level: Basic

Learning objectives:

  1. Identify risk assessment and monitoring requirements for subawards.
  2. Identify steps your institution could take to improve processes and compliance.

Prerequisites: None

Speaker(s):

Kim Carter, MPA, CRA, CPRA, CFRA, Executive Director, Office of Sponsored Projects Administration, University of Kentucky

W106: Collaborative Research and the Role of the Scientist in Society

A variety of collaborative relationships in research amongst academia, industry, government and society result in different roles for the researcher. Whether viewed as a "discoverer of new knowledge”, an “independent authority”, or a “deliverer of tangible goods”, researchers often face conflicting agendas while striving to ensure scientific objectivity and ethical decision-making in their work. Research Administrators can become more effective and productive in their work and interactions with researchers by better understanding these differing roles and dynamics. This presentation will discuss some of these conflicting agendas, the different roles of researchers, how the practice of science is affected, and how the training of new researchers and staff members are impacted. NOTE: Use of an electronic audience response system will further engage participants and foster discussion of this interesting topic.

Content level: Intermediate

Learning objectives:

  1. Attendees will gain a better understanding of a variety of ethical issues encountered by researchers from collaborative relationships between academia, industry, government and society.
  2. Attendees will be better able to identify and respond to the tensions, challenges and expectations researchers face in different collaborative relationships in science.

Prerequisites: A basic working knowledge and fundamental understanding of conflicts of interest and commitment in the research setting.

Speaker(s):

Tony Onofrietti, M.S., CRSS, Director, Research Education, The University of Utah

Wednesday, May 10, 2017 - 10:30am to 11:45am

W205: Intellectual Property Laws and Recent Changes as it Pertains to Protecting Innovation from Universities for Economic Development

As research administers, one of the most difficult issues when it comes to negotiating research contracts with industrial partners is the intellectual property (IP) rights. And increasingly universities and research institutes are looking to protect IP generated so that it can be a basis of a startup. This session will give research administrators a fresh/new perspective on IP and help in the negotiation process.

Content level: Intermediate

Learning objectives:

  1. Understand the different kinds of Intellectual Property (IP).
  2. Understand issues facing both the industry when funding research at the universities.

Prerequisites: None

Speaker(s):

Kannan Grant, BSEE, MBA, Director, Office of Technology Commercialization, University of Alabama in Huntsville

W201: Leading with Emotional Intelligence

Poised, outgoing, cheerful, having empathy for others, being able to express feelings directly but appropriately, and having the capacity for developing relationships. All of these abilities distinguish individuals with high emotional intelligence which is critical to effective leadership. This session provides you with an understanding of why emotional intelligence abilities are important as a leader. And provide you with practical, positive techniques for promoting and improving emotional intelligence as a leader within your business environment. As well as, discovering your hot buttons and how to keep others from pushing them.

Content level: Basic

Learning objectives:

  1. Recognize why emotional intelligence is important in the workplace and the actions that demonstrate emotional intelligence.
  2. Tackle life’s challenges with greater self-awareness and implement strategies for communicating with emotional intelligence.

Prerequisites: None

Speaker(s):

Christy Taylor Bray, Assistant Director, Research Training and Development, Research Services, The University of Texas Medical Branch at Galveston

W203: Applying Quality Improvement Processes in Research Administration

There are better ways to be an effective research administrator by utilizing quality improvement tools for efficiency and workflow. Using a real Case Study, this session will provide skills and provide tools to effectively look at your current processes and see if those processes can be improved to be an effective administrator.

Content level: Basic

Learning objectives:

  1. Understand quality improvement methods.
  2. Take examples of methods to implement in their current workflows.

Prerequisites: Basic

Speaker(s):

Jason Claes, MBA, MSM, GRCRA, Business Manager, Cincinnati Children's Hospital Medical Center

W202: Funding Development

The aim of this session is to demystify the identification of funding opportunities by providing tips and techniques as well as an overview of various types of electronic search directories, engines, services and databases. Key considerations such as application due date, funding limitation, eligibility and other restrictions will be covered. Additionally search strategies using a wide range of funding programs, sources and opportunities applicable to specialty are provided. Participants will also review email alert services and the use of social media, particularly twitter streams as an optimal tool in funding development and dissemination of funding trends and opportunities in a global context. Tracking funding trends utilizing agency funding databases, new award reporting and forecasting via research.gov, etc are also outlined. Other approaches to finding funding such as attending professional meetings to connect with program officers as well as interact with peers with similar interest will be discussed.

Certificate: PA-R

 

Content level: Basic

Learning objectives:

  1. Identify funding opportunities utilizing electronic, social media and interpersonal mechanisms.
  2. Examine best practices in communicating funding opportunities and programs of significance to investigators and interested parties.

Prerequisites: None

Speaker(s):

Amy L. Deborde, Business Director, Cincinnati Children’s Hospital Medical Center

W206: Coverage Analysis, Budget, Clinical Trial Management System… What’s the Connection

Have you ever wondered how a coverage analysis, budget and clinical trial management system fit together?  This presentation will discuss the needs for all three areas.  It will explore how each build on the other and how it can create efficiency for patient billing.

Certificate: CTRA 201-E

Content level: Intermediate

Learning objectives:

  1. Understand the interconnection between a coverage analysis, budget and clinical trial management system.
  2. Understand the downstream effect on patient billing and how it helps create efficiencies. 

Prerequisites: None

Speaker(s):

Stephen Baldwin, Director, Sponsored Programs Administration, Carolinas HealthCare System

W204: SBIR & STTR: Small Business Grant Programs in the University Setting

This session will cover the basics of the Small Business Innovation Research (SBIR) program, a highly competitive program that encourages domestic small businesses to engage in federal R&D that has the potential for commercialization. This program is often suited to the academic investigator who is interested in moving his or her research from the academic to commercial setting.

Content level: Basic

Learning objectives:

  1. Understand the basics of both the SBIR & STTR grant funding programs.
  2. Understand how SBIR & STTR can work for investigators in the academic setting.

Prerequisites: None

Speaker(s):

Jim Stefansic, PhD, President & CEO, Faors Healthcare, LLC