Concurrent Sessions

Monday, February 29, 2016 - 9:30am to 10:45am

M101: Bridging the Gaps – Working with All the Generations in the Workforce

We currently have four different generations working side-by-side in the workplace. Each has their own differing attitudes toward managing one’s own time, texting, social media, organizational structure and, of course, clothing preferences. We must identify the common ground to avoid wasting a lot of time fighting each other instead of working as productive teams.

Content level: Basic

Learning objectives:

  1. Identify the four generations in the workplace and their defining experiences and events. 
  2. Understand the values and potential outcomes of generational interactions in the workplace.

Prerequisites: None

Speaker(s):

Christy Taylor Bray, CRA, Assistant Director of Research Training and Development, Medical Branch University of Texas

M102: 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 just in time (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. This session will also include the perspective of a sponsor’s grants management office.

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):

Camie Morrison, CRA, Director of Sponsored Research, Rutgers University - Camden Campus; Katie Joffee, Grants Management Specialist, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Department of Health & Human Services (DHHS), United States

M103: Uniform Guidance: What's New, What's Not

The new government regulations were created with the intent of streamlining the federal rules governing federal agreements. Understanding what is new in the regulations, what is different and what has remained the same is vital for research administrators. This session will highlight the major sections of the Uniform Guidance (UG) with a focus on the changes from the OMB Circulars and allow for discussion on how these changes may affect how we manage research awards. 

 

Content level: Basic

Learning objectives:

  1. Understand the structure of the Uniform Guidance. 
  2. Understand the major changes in the regulations.

Prerequisites: None

Speaker(s):

Ann Holmes, Masters of Science, Assistant Dean and Denise Clark, Associate Vice-President, University of Maryland

M104: The Impact of the Physician Payments Sunshine Act on Clinical Research

Established by Section 6002 of the Affordable Care Act, the Physician Payments Sunshine Act (“Act”) requires pharmaceutical and medical device manufacturers to report annually to the Department of Health and Human Services payments and other transfers of value furnished to physicians and teaching hospitals. The Act was designed to encourage greater transparency in the relationships between manufacturers and physicians. The Centers for Medicare & Medicaid Services (CMS) is charged with implementing the Act and has attempted to clarify how the Act applies to clinical research.

Content level: Intermediate

Learning objectives:

  1. Identify payments or transfers of value that must be reported. 
  2. Discuss the specific research reporting requirement.

Prerequisites: None

Speaker(s):

Penny Smith, JD, Attorney, Life Science Law Group; LLC; Michelle Sercye, JD, Attorney, Life Science Law Group, LLC; Meena Nayak, Vertex Pharmaceuticals Incorporated USA

M105: Ethics and Compliance in Research: Aren't They the Same Thing?

Decision making in research is often based solely on federal regulations that primarily focus on the institution, the compliance committees and the research team. However, the ethics of research is far broader and is impacted by everyone who is involved in assuring the varied fields of compliance. This presentation addresses a model for ethical decision making; how individuals responsible for budgets and awards, recruitment and informed consent, to working in an adjacent office or laboratory can impact the ethical conduct of research activities. Learning topics will address a model for making ethical decisions, why it takes a village and not an individual to conduct ethical research, rights of whistleblowers and why research is no longer institutional but international.

Content level: Basic

Learning objectives:

  1. Have a model for making ethical decisions. 
  2. Better understand how unethical research impacts far more than the Principal Investigator (PI) or the institution.

Prerequisites: None

Speaker(s):

Norma Epley, MS, CIP Director, Research Integrity & Compliance, East Carolina University

M106: Case Studies in Research Ethics: A Historical Perspective

The proper conduct and reporting of research is of paramount importance to our institutions. Noncompliance can result in severe penalties to the organization, the individual(s) and their reputations. The modern definition of research misconduct however, in the context of responsible conduct of research training, reflects an evolution of hundreds of years of social and ethical issues that have arisen in the practice of scientific research. What may have been acceptable practice a century ago may be considered unacceptable practice by today’s standards. An examination of the global history of biology, chemistry, physics and medicine provides some insightful examples of both responsibly and irresponsibly conducted research by many famous scientists. 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.

Content level: Intermediate

Learning objectives:

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

Prerequisites: None

Speaker(s):

Tony Onofrietti, CRSS, Director, Research Education, The University of Utah

Monday, February 29, 2016 - 11:00am to 12:15pm

LC1: Clinical Trails for Grant Research Administrators

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Renee Vaughan, Duke University

LC2: Working with Investigators and the IRB in the Grant Congruency Process

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Michelle Watkinson, and Swapnali Chaudhari, MD, Rutgers, The State University of New  Jersey

LC3: Tackling the Administrative Burden in Research Administration - One Medical School’s Plan

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Gary Smith, Massachusetts General Hospital Research Institute

M201: Psychology of Leadership: Relationship, Perception and Behavior Management for New Leaders

Assuming a leadership role brings with it a change to the balance of power within a professional community, which makes relationships with those around you complicated and entails employing a specialized management strategy. Whether you are a newly promoted manager or have recently assumed a leadership position in a new institution, navigating these relationships requires self-awareness, an understanding of human behaviors and motivations and a cognizance of multifaceted hierarchical relationships. In this session we will discuss the complexities of managing former peers, engaging with prior managers as contemporaries, establishing yourself as a leader in a new institution and highlight how people’s perceptions of you will ultimately construct your leadership profile. Attendees will learn how to leverage management tools to influence those perceptions to ensure a successful transition into a leadership role.

Content level: Basic

Learning objectives:

  1. Be able to identify how relationships change when a former peer is promoted to a leadership position, and how new leaders coming into an institution are received. 
  2. Possess the tools necessary to influence behaviors of those around them to ensure that their transition into leadership is successful.

 

Prerequisites: None

Speaker(s):

Minessa Konecky, BA, Director of Operations Curadel, LLC

M202: Planning for the Unexpected/Transition - Develop/Use Standard Operating Procedures

Your Institution lost an employee to attrition -How well prepared is your organization to sustain research administration? Research Administrators (RA) are a limited resource; you recruit a replacement. What resources will they have to know how research administration is performed at your institution? Development and use of standard operating procedures (SOPs) defines institutional RA duties and provides a road map for accomplishing them accurately and in a timely fashion. How many times have you heard 'no one told me that' or 'I wasn’t trained to do it that way?' Well written SOPs allow research infrastructure to operate in a continuum, independent of who is in the office and who trains the new person. This session will give practical advice on SOP development: which ones you need, who should develop and write the SOPs and how and when they need to be maintained. Learn from an experienced team how to guide your employees to succeed!

Content level: Intermediate

Learning objectives:

  1. Be able to analyze their internal procedures, organize them into practical standard operating procedures and routinely assess their effectiveness. 
  2. Be able to use a modified Strengths, Weaknesses, Opportunities and Threats (S.W.O.T.) matrix to identify the Standards and Procedures (SOPs) that need to be written, who should write them and order of importance.

 

Prerequisites: None

Speaker(s):

Sandra Mancuso, MA, Director, Grants & Sponsored Programs, Barry University; Kate McCormick, CRA, Research Administrator

 
 

M203: Sub-recipient Management and Monitoring

This session will review the new requirements for sub-recipient management and monitoring under OMB Uniform Guidance 2 CFR Part 200 from pre-award through closeout. The discussion will involve case study examples and demonstration of a 5 Step Toolkit developed to ensure compliance with the new regulations: sub-recipient determination, risk assessment, mitigation, monitoring and enforcement. This session will be interactive so be prepared to share the best practices from your institution.

Content level: Basic

Learning objectives:

  1. Understanding the major changes related to sub-recipient management and monitoring under 2 CFR Part 200. 
  2. Identify resources available to ensure compliance with these new regulations.

Prerequisites: None

Speaker(s):

Donna R. Kiley, CRA, Associate Director, Grants & Contracts Administration, Research Foundation State University of New York (SUNY); Justine Gordon, Director, Grants and Contracts Administration

M204: Dealing with Conflicts of Commitment and Financial Interest

Participants will be provided with an overview of the financial disclosure process required by the federal government. Many researchers are still not aware of the necessity for them to fully disclose all outside interests related to their faculty research role. These strict requirements have led to concerns that the institution is invading their privacy or preventing them from working with pharma to conduct research or establish public partnerships. Participants will be provided with the notification process that was created and is being utilized between the Research Office and the Institutional Review Board (IRB) for the financial review process. This session will provide the audience with real case scenarios, the process of review and resolution, as well as a sample of the management plan that was created.

Content level: Intermediate

Learning objectives:

  1. Utilize the notification process that was created between the Research & IRB Offices to assist investigators in items needed for potential disclosures of conflicts of interest (COIs). 
  2. Provide the audience with a sample of the management plan as a template to use in communicating to investigators what is needed and how to report.

Prerequisites: None

Speaker(s):

Carlotta Rodriguez, CIP, CHRC, Director and Deborah Lazzarino, PhD, Assistant Dean for Research, Rutgers New Jersey Medical School

M205: Keeping Up With Clinical Trials.gov: A Systematic Approach in Maintaining Compliance

Are your clinical trials falling behind in reporting results at ClinicalTrials.gov? If so, there are ways to train and educate your research staff on maintaining compliance. A summary of the trial should be readily available and the results should be accessible to all in a timely manner. Understanding the efficacy of medical intervention represents ethically what the Belmont Report and Declaration of Helsinki speaks to in regards to keeping the results publicly available. Analysis of the data supports the basic principles of evidence based practice and is the foundation of guiding the public in making rationale decisions about their care. This session will review the rational of study registration and data reporting, and recommend steps on how to evaluate where your investigators stand with keeping up with their results reporting and how to resolve the issues. The new updates and information from the recent National Institutes of Health (NIH) ClinicalTrials.gov Train-the-Trainer Workshop will be shared in this presentation, including the latest tools and checklist to enhance your result reporting.

Content level: Intermediate

Learning objectives:

  1. Understand why registration of study and reporting results of a clinical study matter. 
  2. Learn how to summarize and formulate a report for clinical trials by utilizing the latest checklists provided by NIH.

 

Prerequisites: None

Speaker(s):

Cheryl Forst, RN, BSN, CCRP, Director and Niem-Tzu "Rebecca" Chen, Human Subjects Protection Analyst, Rutgers, The State University of New Jersey 

M206: The National Institutes of Health (NIH) Grant Proposal Guide: 273 Pages in 75 Minutes!

We will take the participants through the long and arduous grants.gov NIH proposal application process, but we promise that the workshop will NOT be long and arduous! The application can be extremely intimidating to inexperienced faculty and staff. In this workshop, we will go over and explain each section of the application including the budget and budget justification. We will also relate our experiences with walking Principal Investigators (PIs) painlessly through the process. 

Content level: Basic

Learning objectives:

  1. Be able to approach the NIH grant application with confidence. 
  2. Learn tips for working with new PIs applying to NIH.

Prerequisites: None

Speaker(s):

Stephanie Endy, Associate Vice President for Research, Case Western Reserve University

Monday, February 29, 2016 - 2:15pm to 3:30pm

LC4: IRBs & IACUCs: The Apples and Oranges of Subject Protection

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Lauren Danridge, LSSS, CPIA, IACUC Administrator and Carlotta Rodriguez, MS, CIP, CHRC, Director, Rutgers, The State University of New Jersey

LC5: An Introduction to Working with Private Foundations - Relationship Building

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Sandra Garcia, University of Houston - Downtown

LC12: Familiarization with National Science Foundation (NSF) Proposal Submissions

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

M. Fran Stephens, CRA, Proposal Development Specialist, University of Oklahoma

M301: Adapting, Evolving, Surviving - Managing Change

In the field of Research Administration, "change" is the only thing that’s guaranteed. Growing, downsizing, restructuring, transforming – in some way or form, departments are constantly evolving and shifting. This session is for everyone in hopes that an open and honest exchange of information and experiences can be mutually beneficial for all participants. We will discuss different types of change and provide insights into how change may affect people, the best methods for implementing voluntary and imposed changes, and how to embrace change and grow from it. The presenters have worked in more than ten different positions over the past seven years, and will discuss how various changes affected them and what they learned from these changes. As Charles Darwin said, "It is not the strongest of the most intelligent who will survive but those who can best manage change." 

Content level: Basic

Learning objectives:

  1. Use creative approaches to navigate change for yourself and others around you. 
  2. Openly discuss issues and concerns they have about their own department and offices.

Prerequisites: None

Speaker(s):

Hana Kabashi, Senior Coordinator, University of Maryland, College Park; Mariah M.L. Bauer, PhD, Director of Research Strategy and Management, University of Maryland Center for Advanced Study of Language (CASL); Kate McCormick, Senior Grant Administrator, Suffolk University

 

 

M302: Faculty Transfers: Hello and Goodbye

Faculty come into our university and leave our university very regularly. This presentation will focus on the many responsibilities and duties that face the Department Administrator to achieve a successful faculty transfer. The session will provide a checklist of specific duties and "best practices" that must be accomplished to ensure a seamless transition. The presentation will also provide actual case studies and real-life scenarios so that the participants and presenters can dialogue on these "what would you do now" or "how would you handle this" cases/situations.

Content level: Intermediate

Learning objectives:

  1. Better understand what is needed from them and what he/she needs to do when faculty are transferring into their university. 
  2. Learn what to do when their faculty are leaving their university or transferring within their university to another department or school.

Prerequisites: None

Speaker(s):

William Hoffman, MAS, Department Administrator, Dental School; Karen Sack, BS, Administrator, Department of Physical Therapy and Rehabilitation Science, School of Medicine; and Janet Simons, Director of Research Policy, Office of the Vice President, University of Maryland, Baltimore

 

M303: Cost Transfers - Questions to Ask

Are you asking the right questions when submitting or approving cost transfers? The Uniform Guidance allows you to make decisions based on a certain criteria. However, your interpretation may be different than others. We will review and discuss examples of cost transfers. If you want to learn how to know when a cost transfer is allowable, than this session would be for you.

Content level: Basic

Learning objectives:

  1. To understand the basic framework of Uniform Guidance pertaining to cost transfers.
  2. To understand the importance of asking the right questions.
  3. To understand what you may be asked to approve.

Prerequisites: None

Speaker(s):

Valerie Crickard, MBA, CRA, Associate Director and A. Chea Smith, CRA, Manager, Cost AnalysisUniversity of North Carolina, Charlotte

M304: The Journal’s Role in Research Misconduct Cases

Journals are taking an increasing role in research misconduct cases from reporting misconduct allegations to taking corrective actions.  This session will improve understanding of how journals process these allegations, how they respond to information about a researcher who has fabricated data, what they will let a retraction or correction notice state and when they will post such a notice.

Content level: Intermediate

Learning objectives:

  1. Understand journals handle allegations of misconduct allegations. 
  2. Understand issues with retraction and correction.

Prerequisites: None

Speaker(s):

Debra Parrish, JD, Founder, Parrish Law Offices

M305: To Institutional Review Board (IRB) or Not to Institutional Review Board (IRB): That is the Question

This session will provide research administrators with an overview of the following: when does an institution need an IRB and what regulations apply, what needs to be submitted to the IRB and what regulations and policies apply and overview of the criteria for review of human subjects research.

Content level: Basic

Learning objectives:

  1. Identify which research related activities should be submitted to the IRB. 
  2. Identify human subjects research.

 

Prerequisites: None

Speaker(s):

Donna Hoagland, CIP, CCRC, CHRC, Director, Institutional Review Board and Paula Bistak, DMH, CIP, CHRC, Rutgers, The State University of New Jersey

M306: National Institutes of Health (NIH) Updates (Webinar)

This live webinar-session will cover the latest news from the National Institutes of Health (NIH), including information on the NIH budget, current policy topics, policy reminders and updates on NIH Electronic Research Administration (eRA) activities.

Content level: Basic

Learning objectives:

  1. Learn basic information concerning the NIH, including new, emerging initiatives as well as recurring policy reminders. 
  2. Learn basic information concerning NIH eRA activities, including eRA Commons and electronic submission of NIH grant applications, progress reports and other post-award electronic processes.

Prerequisites: None

Speaker(s):

Michelle Bulls, Director, Office of Policy for Extramural Research Administration (OPERA), National Institutes of Health (NIH)

Monday, February 29, 2016 - 3:45pm to 5:00pm

LC6: Visa 101 for the Research Administrator

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Suann Klechinski, Rutgers, The State University of New Jersey

LC7: Leading & Listening: Community Engagement for Research Administrators

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Zoya Davis-Hamilton and Sarah Marina, Tufts University

M401: Can We Talk? Enhancing Relationships and Communications

This session will take the research administrator one step further than the knowledge all research administrators are expected to have. While research administrators may be proficient in the body of knowledge necessary to do the job, if they do not build and maintain relationships and communication skills they are unlikely to be successful. The purpose of this session is to provide attendees with the skills necessary to build and maintain positive relationships and communication skills with upper administration, colleagues, faculty and staff. Attendees will also use skits to practice their new-found skills.

Content level: Basic

Learning objectives:

  1. Identify the issues that develop when research administrators do not have strong relationships or communication skills. 
  2. Identify techniques that will build and stimulate successful relationships and communications skills.

Prerequisites: None

Speaker(s):

Beverly B. Maddox, EdD, Director of Research Administration, Kennesaw State University; Charna K. Howson, Director of Sponsored Programs, Appalachian State University

M402: Sub-contracting? Answers to Commonly Asked Questions at the Proposal Stage

Sub-awards are normally included in a proposal when the submitting institution cannot complete part of the project. When preparing their proposal, a principal investigator (PI) may ask some of the common questions concerning sub-awards, which include: What is a sub-award and when do I need one? Why is it important for me to know the difference between a sub-award, a consultant agreement and a vendor quote before submitting my proposal? Where do I include the sub-award in the budget? What is generally required when including a sub-award in my proposal? Why do we budget our institution's indirect costs on the sub-award's indirect? When can the sub-award include indirect costs in their budget? What happens when my proposal is funded?

Content level: Basic

Learning objectives:

  1. Explain the complexity involved when a proposal includes a sub-award. 
  2. Understand the difference between a sub-award, a consultant agreement and a vendor quote at the proposal stage.

Prerequisites: None

Speaker(s):

Craig O'Neill, CRA, Manager, Office of Sponsored Programs, Michigan State University

M403: Sponsored Project Closeouts and the Uniform Guidance

This session will cover award management topics that facilitate the successful closing of awards. It will provide an overview of the essential components of awards management as well as identify key closing concerns. The session will discuss best practices for managing sponsored awards that will eliminate or reduce these concerns. It will also discuss the recent and pending changes to closeouts from Health and Human Services (HHS) and the Uniform Guidance.

Content level: Intermediate

Learning objectives:

  1. Participants will be able to identify key closing concerns.
  2. Participants will learn best practices to eliminate common closing problems.

Prerequisites: None

Speaker(s):

Tamara Hill, CRA Director, Research Administration Services and Jen Crockett, Assistant Director, Finance, Grants and Contracts, Emory University

M404: The America Invents Act and Its Effect on Universities

The America Invents Act (AIA) was signed into law in September of 2011 and went into effect between September of 2012 and March of 2013. Since going into effect, the law has changed patenting in the US so that instead of a patent being awarded to the first person to make an invention, the patent is now awarded to the first inventor to file a patent application in the US Patent Office. This change has a number of implications on universities, such as putting more pressure on researchers to file applications expeditiously and calling into question the value of the one year “grace period” between the first public disclosure of an invention and the filing of a patent application on that invention. In addition, the law creates a new filing status for “micro-entities” that may benefit universities, greatly decreases penalties for failing to disclose the “best mode” of implementing an invention and provides new means for third parties to challenge patents both before and after they are issued. This talk is directed towards individuals who already know at least a little about patent law and will highlight how these changes are affecting American universities.

Content level: Intermediate

Learning objectives:

  1. Identify the difference between a “first to invent” patent regime and a “first inventor to file” patent regime. 
  2. Evaluate whether the AIA is successful in improving the quality of issued patents as a result of pre-issuance submissions from third parties and whether costs are likely to increase for universities as a result of “post-grant review.”

 

Prerequisites: None

Speaker(s):

Carl Mahler, JD, Executive Director, Office of Technology Transfer, University of North Carolina, Charlotte

M405: Trends in Research Integrity Investigations

The National Science Foundation (NSF) Office of Inspector General (OIG) is responsible for conducting investigations into allegations of research misconduct and fraud associated with NSF proposals and awards. This talk will outline the basic missions of the OIG and present the details of recent cases our office has investigated. Case studies will include violations of research misconduct regulations, violations of human subject's regulations, peer review violations and fraud. We will also provide an update on our review of university responsible conduct of research (RCR) programs.

Content level: Basic

Learning objectives:

  1. Understand the mission of the Inspector General. 
  2. Understand trends OIG is seeing in violations of rules, regulations and law.

 

Prerequisites: None

Speaker(s):

Aliza Sacknovitz, PhD, Investigative Scientist,Office of Inspector General, National Science Foundation

M406: It's Your Cost of Doing Business. Take It or Leave It.

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.

Content level: Intermediate

Learning objectives:

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

 

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business and Financial Operations, Clinical Trials Office, University of Utah

Tuesday, March 1, 2016 - 9:00am to 10:15am

T101: Effective Delegation Skills for Leaders

Positive delegation skills are one of the most effective ways for 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 current workplace.

Content level: Basic

Learning objectives:

  1. Introduce leaders at all levels to the principles of effective delegation and the various forms of delegating. 
  2. Provide attendees with systematic ways to stay on top of delegated activities so that things do not stop just because they are delegate.

 

Prerequisites: None

Speaker(s):

Debra Schaller-Demers, MSOM, Director, Research Outreach & Compliance, Memorial Sloan Kettering Cancer Center

T102: The Research and Development (R&D) Funding Horizon: A How-to Guide for New Researchers

The 2015 federal budget embodies a commitment to increase investments in science and technology. To achieve this goal, the Budget calls for targeted investments in science, technology and innovation. University federally funded scientific discovery and technological breakthroughs are the primary engines from which the country is expanding the frontiers of human knowledge, responding to the call for innovation and is addressing the challenges and opportunities of the 21st century. Part I gives an overview of the federal research and development (R&D) funding landscape. Part II is s step-by-step guide on where to find funding opportunities and how to tailor searches to faculty research interests. Discuss calculated capture planning to allow for increased time to; evaluate, prepare for and respond to upcoming funding opportunities. Part III will give an overview of federal acquisition regulations.

Content level: Basic

Learning objectives:

  1. Understand 2015/2016 budget funding trends and identify funding opportunity sources & utilization of search mechanisms. 
  2. Understand capture planning tools and capture planning best practices; and understand Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation (DFAR).

 

Prerequisites: None

Speaker(s):

Courtney Boyce, MS, Contracts, Communications & Training Officer and Jessica Atlass Roscoe, Proposal Development Manager, Georgetown University

T103: Burn Baby Burn: Using Burn Rates in Sponsored Project Management

The session will educate research administrators about burn rates on grants from the Department, Central and Sponsor perspectives. Burn rates on research projects are now more important than ever as a tool for sponsored project management. The session will discuss how burn rates can be incorporated into your internal controls and why they should be. The session will discuss methods of calculating the Burn Rate. Why does a burn rate matter? What does a burn rate tell you about a project's expenses? How to communicate the burn rate to faculty? How to use the burn rate to project expenses? In answering and discussing these questions, the research administrator will gain in-depth understanding of how integral Burn Rates are to strong financial and project management of research.

Content level: Intermediate

Learning objectives:

  1. Understand, analyze and communicate their sponsored project burn rates. 
  2. Incorporate Burn Rates into their internal controls.

 

Prerequisites: None

Speaker(s):

Marcos Garza, MPA, CRA, Research Administrator, Shock Trauma, University of Maryland, Baltimore

 

T104: Negotiating Clinical Trial Agreements with Industry - The Key Issues

This session addresses the four key issues in clinical trial agreements between academic medical institutions and industry sponsors: Confidentiality, Publication, Intellectual Property Rights and Indemnification. The session will include discussion of the perspectives of both parties and practical solutions to streamline the negotiation process and achieve terms that are acceptable to both parties.

Content level: Basic

Learning objectives:

  1. Understand the importance of the four key provisions in clinical trial agreements between academic medical institutions and industry sponsors. 
  2. Gain practical knowledge of how to negotiate these challenging issues.

 

Prerequisites: None

Speaker(s):

Karen Mullin, JD, LLM, Chief General Counsel, Director of Technology Development, The Forsyth Institute

T105: Detecting Compliance and Ethics Issues in a Complex Research Environment

Ensuring compliance and ethics in the current research climate is becoming increasingly complex as we enter into global collaborations, as the rules continue to change and as around the clock media brings constant attention to research ethics. How do we detect compliance and ethics issues in daily communications with principal investigators (PIs), administrators and collaborators? This is the focus of this workshop. The session aims to introduce 2-3 short case studies through which the audience (in small groups or as a whole - depending on size) can learn to detect the different types of compliance and ethics issues that may arise in a single case.

Content level: Basic

Learning objectives:

  1. Detect various compliance and ethics issues in specific scenarios. 
  2. Analyze individual cases such that they are able to recognize the inter-dependencies among different compliance and ethics areas.

Prerequisites: None

Speaker(s):

Farida Lada, MBA, University Director for Research Compliance, The City University of New York

T106: National Institutes of Health (NIH) Post-award Prior Approvals: When You Need to Call NIH

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 the National Institutes of Health (NIH) prior approval is a definite maybe! This session will address NIH post-award prior approval requirements for grantees and explain when you need to contact NIH staff. The presenters will discuss the specific actions that require prior approval and what materials grantees should provide for NIH to review and respond to the request.

Content level: Intermediate

Learning objectives:

  1. Be able to identify what actions require prior approval from NIH and where to locate NIH policy regarding prior approvals. 
  2. Know what items NIH needs to review and respond to prior approval requests and best practices for submitting these items.

 

Prerequisites: None

Speaker(s):

Jessica Moise, Senior Associate Dean for Sponsored Programs, Icahn School of Medicine, Mount Sinai; Katie Joffee, Grants Management Specialist; and Mark Langer, Grants Management Specialist/Officer, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Department of Health and Human Services, National Institutes of Health

Tuesday, March 1, 2016 - 10:30am to 11:45am

T201: Challenging Traditional Ways - Leadership, Trust and Reducing the Administrative Burden

This session will outline how using Jim Kouzes' and Barry Posner's The Five Practices of Exemplary Leadership® can help build trust and reduce the administrative burden for your faculty. The Five Practices of Exemplary Leadership® will be reviewed and the panelist will give examples of how they have used these practices to build relationships at their institution and improve business processes.  

Content level: Intermediate

Learning objectives:

  1. Become familiar with The Five Practices of Exemplary Leadership® and learn how to apply these concepts to business practices at one's institution. 
  2. Become familiar with ways to streamline business practices and reduce the administrative burden.

 

Prerequisites: None

Speaker(s):

Anita Mills, CRA, Solutions Consultant, Evisions, Inc.; Paula M. Means, MPA, Wake Forest University, Assistant Dean for Research, Biomedical Research Services and Administration; Susan Wyatt Sedwick, PhD, CRA, CSM, Consulting Associate, Attain; Karen D. Mitchell, Senior Director, Temple University, Office of the Vice President for Research Administration

T202: Groupthink: Working Collectively to Achieve Pre- and Post-award Goals

Institutions vary in size, grant activity, resources and needs. It is essential for mid-level research administrators to work together as a group, share ideas, tips, advice, lessons learned and leverage resources and knowledge on pre- and post-award issues. The City University of New York (CUNY) is a large university system that consists of 24 colleges. The CUNY Mid-Level Exchange was established in 2013 and meets bi-monthly to discuss topics such as complying with responsible conduct research (RCR)/conflict of interest (COI) requirements, legal contracts, grant personnel, cost sharing and effort reporting, funding opportunities and professional development. In this session, attendees will be given an overview of this highly successful initiative and learn how they can implement it in their institutions at the school, departmental, institute or institutional level.

Content level: Basic

Learning objectives:

  1. Identify ways you can leverage your resources and knowledge.
  2. Identify and differentiate what topics/ideas are appropriate for this approach.

Prerequisites: None

Speaker(s):

Carolynn Julien, MS, Associate Director, Hunter College, City University of New York (CUNY)

T203: Customized Strategies for Post-award Monitoring and Budget Management

This session will focus on an overview of the post-award process and will identify the stages and activities that are essential for budget monitoring. This will include a review of basic terms used in grant management and a review of the Office of Management and Budget (OMB) Uniform Guidance. The presentation will also review basic post-award management principals including common federal rules and regulations, such as salary caps and non-allowable expenditures. Correspondingly, participants will learn how to find additional information related to specific funders' rules. It will also review common mistakes and areas of caution when managing grants and the importance of good financial management techniques. There will be an active part to show participants various methods for effective post award management including excel spreadsheet templates and tools. Post-award grants management is an interactive process and this presentation will help to demystify the process and ensure good accounting practices.

 

Content level: Intermediate

Learning objectives:

  1. Understand basic grant rules and terminology to improve accountability, efficiency and minimize potential noncompliance with established Uniform Guidance guidelines. 
  2. Gain an understanding of various tools and techniques to monitor budgets and knowledge of common Federal and Non-profit budgeting principals. 

 

Prerequisites: None

Speaker(s):

Piotr Dybas, CRA, Post-Award and Business Manager and David W. Allen, CPA, Associate Dean for Business and Administration, Virginia Commonwealth University

 

T204: Grants and Contracts Language: What A Department Administrator Should Watch out and Question

This session will address some of the problematic grants and contracts language that a Department Research Administrator encounters, such as intellectual property clauses, Principal Investigator (PI) questions on export control, confidentiality provisions, publications/publicity rights and associated problematic Federal Acquisition Regulation (FAR) clauses.

Content level: Basic

Learning objectives:

  1. Learn how to identify potential problematic grants and contracts language.  
  2. Understand how to highlight and question common legal problematic language.

Prerequisites: None

Speaker(s):

Lori Benjamin, CRA, Senior Research Administrator, Massachusetts General Hospital; Geraldine M. Pierre, MSc, JD, Grant and Contract Manager, Department of Health Policy and Management, School of Public Health, Boston University

T205: Landmark Research Integrity Cases

This session will review some of the landmark misconduct cases and how they have shaped the response to research misconduct allegations. This will include a review of the court cases, the significant cases prosecuted by the Office of Research Integrity (ORI) and the cases in which criminal charges were involved. The sessions will also include a summary of the sanctions imposed by the institutions and the government agencies on the respondents in these cases. 

Content level: Basic

Learning objectives:

  1. Analyze the consequences of misconduct findings for both individual respondents and institutions. 
  2. Evaluate the ways in which landmark misconduct cases have influenced the government's response to subsequent cases.

 

Prerequisites: None

Speaker(s):

Bridget Noonan, JD, Associate, Parrish Law Offices

T206: National Science Foundation (NSF) Update

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) 2016 and 2017 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 Hunter, Senior Grant and Agreement Policy Specialist, National Science Foundation (NSF)

Tuesday, March 1, 2016 - 1:45pm to 3:00pm

T301: Meaningful Metrics

Metric reporting is usually driven by upper management seeking information about departmental productivity. However, metrics can be an important tool for Research Administrators seeking to evaluate various aspects of their core responsibilities. Many research administrators find that the collection of data is often cumbersome, time consuming, inaccurate and under-utilized. This session will transform your thinking about metrics.

Content level: Basic

Learning objectives:

  1. Identify how to differentiate data versus metrics and identify ways that researcher administrators can benefit from tracking metrics. 
  2. Explore what data to capture and how to transform it into metrics which can express meaningful information.

Prerequisites: None

Speaker(s):

Paula Bistak, DMH, RN, Executive Director, Human Subject Protection Program and Brian Khaitman, MA, Unit Coordinator, Rutgers University

T302: Crowdfunding 101 for Research Administrators

While many institutions have determined that crowd funding should be treated as a donation, sponsored projects offices keep getting pulled back into the fray. With decreasing funding rates and greater competition for federal funding, principal investigators are eager to explore crowd funding as an alternative funding venue with seemingly fewer strings attached. Sites such as Kickstarter, Experiment.com and Benefunder are just a few of the names that may have popped up on your radar. Will or does your institution allow the initial fees for setup of the websites to be charged to sponsored projects? Is your institution entering into exclusive agreements with one crowd funding site or perhaps creating your own crowd funding site? Are you allowing faculty to sign these agreements without institutional involvement? The lists of questions that will be explored are numerous.

Content level: Intermediate

Learning objectives:

  1. Identify policies and procedures that should be in place for accepting and managing these funds. 
  2. Understand that "one-size" may not fit all as crowd funding purveyors differ.

 

Prerequisites: None

Speaker(s):

Susan Sedwick, PhD, CRA, CSM, Consultant, Attain, LLC

 
 

T303: Preparing the Facilities and Administrative (F&A) Proposal at a Predominately Undergraduate Institutions (PUI)

We recently received the first-ever F&A rate approval at Stevenson University, a small Predominately Undergraduate University (PUI) that is actively trying to grow its research base. This will be a guided tour through the short form process, including interpreting the instructions, gathering data, using pivot tables in Excel to analyze the data and working with the Department of Health and Human Services (HHS) to resolve questions.

Content level: Basic

Learning objectives:

  1. Understand the short form application process. 
  2. Learn how pivot tables work and can be used in complex problem-solving.

 

Prerequisites: None

Speaker(s):

James Rose, CPA, CRA, Grants Administrator, Stevenson University

T305: The Intersection of Grants Management and Compliance

Why do grants managers need to understand compliance policies and procedures? Why do compliance personnel need to understand grant submission and award acceptance policies and procedures? Often, the research compliance committees and the Sponsored Program Office work in silos and neither may truly appreciate the processes, deadlines and responsibilities of the other. In order to ensure timely communication with sponsors, compliant grant applications and progress reports and audit-ready grants management records, it is best when all sides are in sync and can ensure grant congruency.

Content level: Intermediate

Learning objectives:

  1. Explore best practices for maintaining quality assurance in grants management with regard to research subjects protections and compliance information. 
  2. Share strategies for communicating more effectively with colleagues in order to achieve grant congruency and accurate records for all appropriate offices.

 

Prerequisites: None

Speaker(s):

Debra Schaller-Demers, MSOM, Director, Research Outreach and Compliance and Erik Schneebeck, JD, Institutional Compliance Manager, Conflicts of Interest, Memorial Sloan Kettering Cancer Center

 

T306: New York University Langone Medical Center (NYULMC) Superstorm Sandy Recovery Efforts: Three Years Later

The NYULMC pre- and post-award management offices will discuss the administrative steps that were taken immediately after Super Storm Sandy through the closing out of the National Institutes of Health (NIH) Disaster Relief Appropriations Act (DRAA) funds. Discussion points will include the mobilization of staff and the proposal submission plan, the establishment of the Sandy Advisors and Recovery Assistance group, award set-up and monitoring, progress report requirements, Office of Inspector General (OIG) auditing and Improper Payment Act Monitoring.

Content level: Basic

Learning objectives:

  1. Understand the requirements and challenges of managing NIH DRAA funds. 
  2. Understand what steps can mitigate our research administrative challenges if a disaster were ever to occur to their institution.

 

Prerequisites: None

Speaker(s):

Sara Stanley, MA, CRA, Associate Director, Sponsored Programs Administration, Tony Carna, MBA, Senior Director, Sponsored Programs Administration, Mario Reyes, MBA, Senior Director, Research Finance Operations, Regulatory Reporting & Compliance, and Tracey Volz, Assistant Director, Research Finance Operations, Reporting & Portfolio Management, School of Medicine, New York University

 

Tuesday, March 1, 2016 - 3:15pm to 4:30pm

LC8: Advanced Issues in Clinical Trails Management

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Dhanonjoy Saha, PhD, Albert Einstein College of Medicine

LC9: Revisiting the Uniform Guidance

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Stephanie Endy, Case Western Reserve University

T401: Leadership Development for Research Administrators: Perils & Pitfalls for New Managers

Learning to manage people can be difficult. As a new manager, to be effective you must develop and utilize new skills. However, the majority of new managers and supervisors do not receive any training or coaching prior to beginning their new position. This interactive session will discuss common new manager mistakes and share the experiences of the panelists and their transition to management.

 

Content level: Basic

Learning objectives:

  1. Identify common mistakes. 
  2. Identify resources and coping mechanisms to ease the transition to management.

 

Prerequisites: None

Speaker(s):

Jen Crockett, Associate Director, Finance, Grants and Contracts and Tamara Hill, MA, CRA, Director, Research Administration Services, Emory University

 

T402: With Departmental Administrators; Without Departmental Administrators. How do you Survive?

Institutions vary in size, grant activity, resources and needs. It is essential for mid-level research administrators to work together as a group, share ideas, tips, advice, lessons learned and leverage resources and knowledge on pre- and post-award issues. The City University of New York (CUNY) is a large university system that consists of 24 colleges. The CUNY Mid-Level Exchange was established in 2013 and meets bi-monthly to discuss topics such as complying with responsible conduct research (RCR)/conflict of interest (COI) requirements, legal contracts, grant personnel, cost sharing and effort reporting, funding opportunities and professional development. In this session, attendees will be given an overview of this highly successful initiative and learn how they can implement it in their institutions at the school, departmental, institute or institutional lDepartmental administrator, what’s that? In the 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. How to develop an infrastructure in a PUI that facilitates pre and post processes.
  2. To discuss the pros and cons of having pre- and post-award under the same roof. Identify strategies to evaluate effectiveness. Useful tools to assist in structuring an office.

 

Prerequisites: None

Speaker(s):

Beverly Morehouse, MBA, Grants & Contracts Specialist, Sephen F. Austin State University; Joyce Donnelly, Administrator and Karen D. Mitchell, MBA, Senior Director, Grants Management, Temple University

T403: Supporting Research Service Centers and Study Teams: Removing Barriers to Clinical Research

With an increased focus on reducing research start up time, identifying futile studies and improving the quality, sustainability and efficiency of clinical and translational research, innovative and cost effective solutions are being actively sought. The South Carolina Clinical & Translational Research Institute (SCTR), a National Institutes of Health, Clinical and Translational Science Award (CTSA) institution, is seeking to remove barriers to clinical research. South Carolina Clinical and Translation Research Institute (SPARC) Request©, an open source service center management system was developed by SCTR has been adopted by 11 other CTSAs encompassing over 30 institutions. SPARC provides a central portal for researchers to browse research services to identify providers and services to support their research and obtain pricing for budget development, reducing proposal budget development time from weeks to minutes. Billing compliance, status tracking, document sharing, work fulfillment, invoicing and reporting functionality reduce the administrative burden and cost of managing research support service centers. New functionality in development includes interfaces with other research and electronic medical record systems to create a research management learning system. Metric tracking, comparison of target and actual accruals, reporting and visualization graphics related to study start, accrual and financial management will be introduced to study teams in an iterative continuous quality improvement process.

Content level: Intermediate

Learning objectives:

  1. Describe three barriers to clinical and translational research. 
  2. Describe solutions to reduce administrative burden and support financial sustainability of service centers.

 

Prerequisites: None

Speaker(s):

Royce Sampson, MSN, RN, CRA, Research Assistant Professor/Chief Operations Officer; Randal Davis, Project Director, South Carolina Clinical and Translational Research Institute; Stehpen Skelton, Finance and Grants Administrator, South Carolina Clinical & Translational Research Institute, Medical University of South Carolina 

T404: Master Research Agreements: Some Lessons from the Trenches

Master Research Agreements are becoming increasingly popular as universities' attempt to establish deeper connections with for-profit research sponsors. A well-constructed Master Research Agreement specifies many of the legal terms and conditions under which research will be conducted so that individual projects can be processed quickly and with significantly decreased burden on the contract negotiators. However, a poorly constructed Master Agreement can create unrealistic expectations, impose unexpected burdens on one or both of the parties and generally create more problems than they are worth. This talk addresses when it is appropriate to establish a Master Research Agreement (and some situations when it is not), what the agreement should contain, how to build in maximum flexibility and some of the less obvious pitfalls awaiting the unwary negotiator.

Content level: Basic

Learning objectives:

  1. Learn how to maximize flexibility in Master Research Agreements by using a good template for "Task Orders." 
  2. Establish better control of the use of Master Research Agreements by using "opt in" language rather than "one size fits all" language.

 

Prerequisites: None

Speaker(s):

Carl Mahler, JD, Executive Director, Office of Technology Transfer, University of North Carolina, Charlotte 

T405: Rethinking Research Compliance: Helping Researchers through Program and Process Improvement

Have your resources been decreasing while demands are increasing? Are existing resources being used in the best way possible? Learn how to evaluate, rethink and re-engineer research compliance programs and in doing so, provide data to executives to justify increasing resources.

Being research-friendly, researcher-friendly and compliant as an institution are not mutually exclusive goals. Taken together they can serve as the starting point of a conversation and develop into a plan toward improvement. This session will share lessons learned from multiple universities toward re-developing our research compliance programs, through the use of a case study. Our ongoing goal is to facilitate compliance through education and client support, particularly in reducing burden to staff and researchers whenever possible.

Content level: Intermediate

Learning objectives:

  1. Learn how to develop tools that enable you to identify needs, assess risks and create a plan toward program improvement.
  2. Willingness to read and discuss the application of federal regulations.

Prerequisites: None

Speaker(s):

Bernardica Sculac Stern, Sponsored Projects and Research Manager, The New School

 

T406: Spotlight on Sponsors

If the array of sponsors and differing submission systems seems overwhelming, then this is the session for you. Let's shine a spotlight on many of the major sponsors (federal and non-federal) and cut through the confusion. We'll overview differing submission systems, special sponsor requirements and provide helpful tips.  

Content level: Basic

Learning objectives:

  1. Understand of some of the many different submission systems used in sponsored projects. 
  2. Identify some of the gaps they or their organization may have in sponsor requirements or systems.

 

Prerequisites: None

Speaker(s):

Fran Stephens, CRA, Proposal Development Specialist, University of Oklahoma

Wednesday, March 2, 2016 - 9:00am to 10:15am

W101: Working with Difficult People (or Are They Just Different?)

Everyone's work day is filled with them: people who frustrate, impede, maneuver, undermine, plot, connive and whine. We often view these individuals as being difficult. The question we must ask ourselves is "Are they difficult, or just different?" This session will help you identify the four personality types you engage each day and understand why they are not often difficult to work with, just different.

Content level: Basic

Learning objectives:

  1. Recognize three common mistakes we make when working with others. 
  2. Find a more productive and less stressful method of working with others.

 

Prerequisites: None

Speaker(s):

Gloria Greene, CRA, Director, Office of Sponsored Programs, The University of Alabama, Huntsville

W102: Electronic Research Administration (eRA) Overview/Submission Technologies

This session offers some explanation and discussion on what electronic research administration (eRA) is and a historical overview of eRA. Features to consider when establishing the eRA framework of an organization are reviewed and system-to-system interfaces will be touched on. Funding development tools such as Research.gov, Grants.gov, Foundationcenter.org, etc. that assist in locating and submitting to funding will be discussed. Common electronic submission systems such as Grants.gov and National Science Foundation (NSF) Fastlane will be overviewed including strategies and tips for successful submissions.

Content level: Basic

Learning objectives:

  1. Identify key features of common electronic proposal submission systems relevant to pre-award processes. 
  2. Understand general expectations of major federal electronic submission programs such as Grants.gov and NSF Fastlane.

 

Prerequisites: None

Speaker(s):

Fran Stephens, CRA, Proposal Development Specialist, University of Oklahoma

 

W103: Cost Sharing - How my "Free" Bahamas Cruise wasn't Really Free!

Participants will learn about cost sharing concepts through the story of my "free" cruise. For example, I won the cruise but had to pay the taxes and port fees, which is mandatory cost sharing. I went on excursions to enhance the experience which is voluntary cost sharing. All cost sharing types will be discussed with real-world examples provided. A sample strategy for cost sharing commitments, tracking, monitoring and reporting will be reviewed and discussed. This will be a fun, interactive session complete with Hawaiian leis, tropical wear and a faux pineapple drink!

Content level: Basic

Learning objectives:

  1. Explain cost sharing concepts by relating the concepts to everyday events. 
  2. Make use of a sample cost sharing planning, tracking and monitoring design.

 

Prerequisites: None

Speaker(s):

Terri Vallery, CRA, Assistant Director, Office of Research & Commercialization, University of Central Florida

W104: Indemnification: It's not Me, it's You

An in-depth discussion of the types of indemnity required and the justification for both commercially funded and grant funded research agreements. This presentation will address investigator and sponsor initiated trials, pre-clinical research agreements and what you should be indemnifying.

Content level: Intermediate

Learning objectives:

  1. Evaluate the use of unilateral sponsor vs. standard bilateral indemnity. 
  2. Analyze indemnification related to drugs and devices vs. results and intellectual property (IP) only.

 

Prerequisites: None

Speaker(s):

Nicole Leonard, JD, Director and Carlos Braxton, JD, MA, Assistant Director, Office of Research Administration, School of Medicine, The Johns Hopkins University

 

W105: Research Education – Balancing Knowledge and Compliance

Research Administration can be a dizzying world of compliance, ethics and best practices. There are rules our research staffs must follow, rules that should be followed and a host of others that probably fall somewhere in between. Navigating the world of grants management can get confusing for first time investigators, as well as for some seasoned individuals dealing with the ever-changing political and funding landscape. A central Research Education Office helps manage the training needs of a research staff – from investigator to lab staff to office coordinators and grants administrators. Working within a central research administration office, this team of education professionals can help determine what training needs to be offered, help with staff development and keep an academic research community on top of the latest developments in research administration. We will offer examples of classes to offer, practical tips on developing the courses that matter to the research community and advice to help you begin to develop a comprehensive research education program at your campus.

Content level: Basic

Learning objectives:

  1. Be able to identify the educational needs of their institution. 
  2. Better understand how to implement a centralized research education program.

 

Prerequisites: None

Speaker(s):

Christy Taylor Bray, CRA, Assistant Director of Research Training and Development, Medical Branch, University of Texas

 

W106: Defense Advanced Research Projects Agency (DARPA): From Application Submission to Award Management

"I want to apply for a DARPA award!" is a sentence that may strike fear into the most seasoned research administrator when uttered by a principal investigator (PI), especially when the PI has never worked with DARPA or the Department of Defense (DOD) before. DARPA applications are detailed and complex and the process is very different from the highly standardized application process for our typical sponsors (NIH, NSF, USDA, etc). Once your DARPA application is funded, the real project starts. Managing science in a results-driven sponsored research project is aided by excellent administrative and financial management of the award. In this session, the speakers will give an overview of the sponsor, discuss the pre-award process (where to find funding opportunities and explain how to respond to DARPA's funding announcements) and the post-award management (transitioning from a proposer to a performer, reporting and funding) of DARPA grants, cooperative agreements and contracts.

 

Content level: Intermediate

Learning objectives:

  1. Understand the DARPA mentality, where to find DARPA funding opportunities and how to construct an application. 
  2. Identify key compliance and award management issues, including reporting and Institutional Review Board (IRB) / Institutional Animal Care and Use Committee (IACUC) requirements.

 

Prerequisites: None

Speaker(s):

Will Helmrath, MSM, CRA, Grants and Contracts Coordinator, Institute of Agriculture, University of Tennessee; Chad Restrick, MSM, CRA, School of Medicine, Johns Hopkins University

Wednesday, March 2, 2016 - 10:30am to 11:45am

LC10: Private Foundations and Research Administration

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Cherri Helms, Kennedy Krieger Research Institute; Gayle Mowbray Walters, Johns Hopkins University

LC11: Project Budgeting for the New Research Administrator

Content level: Basic

Learning objectives:

The Learning Cafés offer a venue for attendees to exchange ideas, ask questions, share solutions and “continue the conversation” about topics in research administration.

Prerequisites: None

Speaker(s):

Tamara Hill, Emory University

W201: Leadership during Tough Economic Times

As funded research becomes more difficult to obtain, institutions scramble to understand the impact of how reduced research dollars will affect their research enterprise. Successful leadership in tough times means creating a sense of urgency, gaining mutual commitment to action and re-examining the leadership model in your organization to be able to do more with less. This session will discuss leadership initiatives to remain proactive, strive for improvement, focus on your people and maintain the right mindset to continue to achieve success.

Content level: Basic

Learning objectives:

  1. Learn how to maximize employee engagement. 
  2. Understand the difference between reactive and proactive leadership.

 

Prerequisites: None

Speaker(s):

Erin Bailey, MSM, CRA, Chief Financial Officer, Clinical Translational Research Award, University at Buffalo; Timothy R. Schailey, MS, Director, Research Administration, Office of Research Administration, Thomas Jefferson University

W202: Contract Drafting and Negotiation

This session will provide an in-depth examination of drafting and negotiating research agreements. Topics will include contract anatomy, standard clauses and troublesome language. We will discuss sponsor needs versus university requirements and communication techniques to find common ground. Case study examples and agreement templates will be used to illustrate and discuss best practices and common pitfalls.

Content level: Basic

Learning objectives:

  1. Identify the anatomy of a contract and understand common legal terms. 
  2. Develop effective communication strategies to negotiate troublesome clauses.

 

Prerequisites: None

Speaker(s):

Donna R Kiley, CRA, Associate Director, Grants & Contracts Administration, Research Foundation, State University of New York; Justine Gordon, Director, Grants and Contracts Administration

 
 

W203: 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 and 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.

Content level: Basic

Learning objectives:

  1. Define main differences in post-award management of fixed-price contracts. 
  2. Utilize concepts and techniques in managing capitated budgets.

 

Prerequisites: None

Speaker(s):

Pavel Kruchek, Director, Business and Financial Operations, Clinical Trials Office, Vanessa Bryant, Senior Budget Analyst, University of Utah

 

W204: Policy and Procedure: What we Really Need to Comply with Federal Regulations

Developing and implementing solid policies and procedures is imperative to complying with federal regulations when conducting business with the federal government – that is, conducting research through grants, contracts or co-operative agreements, or providing or delivering other services. While there is a consistency among federal agencies on the basic requirements, some agencies have additional requirements that need frequent updates or monitoring. This session will review the requirements, starting with National Institutes of Health (NIH), which has 57 basic policy requirements, and compare these with other agencies, especially Department of Defense, National Science Foundation (NSF) and Center for Disease Control and Prevention (CDC). The successful implementation of these policies and procedures not only keeps an institution compliant, it also increases efficiency and productivity. This session will also address barriers to developing and implementing policies and show ways to overcome these impediments to improve efficiency and productivity.  

Content level: Intermediate

Learning objectives:

  1. Learn the basic policy requirements for conducting federally-funded projects. 
  2. Understand the complexities of the policy implementations and learn ways to develop and implement policies successfully to improve productivity.

 

Prerequisites: None

Speaker(s):

Dhanonjoy Saha, PhD, Director, Office of Grant Support, Albert Einstein College of Medicine; John Scarfone, JD Associate General Counsel and Director of Compliance, Albert Einstein College of Medicine

W205: Responsible Animal Research: Creating a Culture of Care, Integrity and Responsibility

Institutions must provide adequate support for the proper care and use of animals in research. For this to occur, it is important that leadership understand the causes and potential risks for noncompliance and the resources and steps that may be needed to prevent their occurrence. Central to this session will be a discussion of what an integrated academic medical center has put in place to address the current challenges in conducting animal research including: effective tools and techniques for training and outreach, challenges and complexities unique to animal research involving non-US trained scientists, the impact of special interest animal groups, the value of working with public relations and media to help educate and inform leadership and the community and the visible role of the Institutional Official as a part of coordinated animal research team.  Presenters will provide tools, processes and techniques that participants can take back to their institutions.  

Content level: Intermediate

Learning objectives:

  1. Understand the roles, responsibilities and infrastructure required when engaging in animal research. 
  2. Manage and assess problems and issues related to animal research when they arise.

 

Prerequisites: None

Speaker(s):

Paula Means, MPA, Assistant Dean for Research and Colleen Bennett, Manager, Animal Education and Outreach, Wake Forest University

W206: My National Center for Biotechnology Information (NCBI): Bibliographies, Biosketches and National Institutes of Health (NIH) Public Access Policy

Keeping up with the changes that the National Institutes of Health (NIH) make to grant applications can be a challenge. My NCBI is an online resource that allows researchers to maintain a current bibliography, verify that all publications comply with the NIH Public Access Policy and build biographical sketches (biosketches) in proper NIH and National Science Foundation (NSF) formats. My NCBI can be linked to a researcher's electronic Research Administrator (eRA) Commons account, which allows researchers to quickly populate biosketches with NIH grants. This session will introduce attendees to the My NCBI tool and cover the new requirements for NIH-style biosketches.

Content level: Basic

Learning objectives:

  1. Learn to build a bibliography in My NCBI and determine if their publications are compliant with the NIH Public Access Policy. 
  2. Learn to build a biographical sketch in the new NIH format or the NSF format.

 

Prerequisites: None

Speaker(s):

Carson Harrod, PhD, Assistant Investigator, Baylor Research Institute