Concurrent Sessions

As research organizations transition from the COVID era and aspire to continually improve service to their community of stakeholders, they are simultaneously faced with management of increased research project complexity, pressure to comply with new regulatory requirements, and unprecedented staff turnover. Amid these challenges, institutions can explore existing organizational models that clearly delineate Central Office team structure and strategic allocation of responsibilities. With an understanding of these models, they can then adopt a results-achieving organization structure that is aligned to their individual institution’s characteristics and needs. Even given changing sponsor requirements and the ever-present demand for efficiency, operating model review can result in progress toward a solution that delivers results. This session examines some of the industry’s common and most forward-thinking models, highlighting the characteristics and considerations for each.

Content Level: Intermediate

Learning Objectives:

1. Participants are introduced to multiple organizational models for Central research administration offices, and can describe their own institution in comparison/contrast to these models.
2. Participants will be able to identify pros/cons related to each model and how to evaluate which might be a better fit for their organization.

Speaker(s):
Arpa Orojian, Specialist Master, Deloitte Consulting LLP; Ella Trubman, Senior Director, The Scripps Research Institute

1. Analyze negotiation strategies, identify their individual strengths and weaknesses and list common mistakes made by negotiators on each side of the table.
2. Describe the benefits of compromise and tools to help find it.

In a research administration world that has separate Pre-Award and Post-Award roles & responsibilities, we hear often "But I'm Pre-Award". The question is it really just Pre-Award? We will explore together how Pre-Award is integral to the Post-Award team and discover best practices and ideas of how to think "down the road", develop the team approach to Pre-Award and ideas of handing off that notice of award.

Content Level: Intermediate

Learning Objectives:

1. Understand the important relationship between Pre-Award and Post-Award.
2. Building the bridge, break down the invisible wall and cross team lines between Pre-Award and Post-Award.

Speaker(s):
Lorrie Robbins, CRA, Assistant Director, Grants & Contracts, Duke University; Betty Morgan, Grants and Contracts Manager, Duke University

This panel discussion will provide many perspectives on submission and non-financial transactions from the Recipient Organization (Department, School and Central Administration) and the NIH. We will cover topics from Other Faculty Support, Data Management and Sharing Plans in proposals, Relinquishments and Faculty Transfer applications, Prior Approval requests, and Reporting (annual and final RPPRs) and Close-out from the viewpoints of the Institution and the NIH. In this interactive panel discussion, we will also discuss strategies for effective engagement among the PI, the NIH and the Institution.

Content Level: Basic

Learning Objectives:

1. Have a clearer understanding of proposal review to award close-out from the perspective of the Recipient Organization and the NIH.
2. Take some or all of the different strategies discussed for effective engagement among the PI, the NIH and the Institution back to their respective institution.

Speaker(s):
Sandra Garcia, CRA, Ed.D., Assistant Vice President OSPA, University of Texas San Antonio; William Hoffman, Jr., MAS, Research Administrator, University of Maryland, Baltimore; Debbie Pettitt, Sr. Grants Management Officer, National Institute of Health; Janet Simons, Director, Research Policy and Training Export Officer, Sponsored Programs Administration University of Maryland, Baltimore; Artisha Wright, Compliance Section Chief, National Institute of Health

1. Understand what knowledge transfer truly is compared to what is often perceived.
2. Understand different options for knowledge transfer.

Being a director is a juggling act. There are various types of administrative balls to handle throughout the research lifecycle. This session will look at various positions at an institution, focusing on the department and central office levels. How one balances the juggling act of research administration depends on your constituents, university structure, and the relationship between directors within the central offices and departments. We will look at a few scenarios on how being a director affected administrative outcomes and how working together can avoid near misses. Bring your juggling balls to discuss how leadership works at your institution and what takeaways our discussion can provide to bring a balance to your institution. 

Content Level: Intermediate

Learning Objectives:
1. Participants will learn and discuss tips for building relationships between the central offices and departments when working through the lifecycle of research administration.
2. Participants will discover ways to balance leadership roles to comply with university and sponsor compliance while meeting faculty needs.

Speaker(s):
Tim Reuter, Sr. Director, Post Award Operations, Stanford University; Sarah Saxton, Executive Director, Sponsored Programs, Drexel University

1. Identify productivity tools that can be useful in managing workloads in research administration and facilitate collaboration across departments.
2. Determine whether these tools could be beneficial for their respective departments and learn best practices for implementation.

1. Provide high-level view the various areas to consider when launching an Investigator Initiated Study (IIS). Discuss common “blind spots” and how to navigate them.
2. Explore the “site as sponsor” concept and associated responsibilities. Discussion of specific considerations when site becomes the sponsor of an IIS.

1. List key strategies for prioritizing and organizing tasks and duties.
2. Identify best practices for ensuring compliance with NIH submission guidelines.

1. Understand important cases, changes and issues in the federal grants legal landscape from the past six months.
2. Offer strategies to promote best practices going forward in research grants management as a result of these regulatory changes and case law precedent.

1. How to convey to stakeholders that implementing change management is not only good for your department, but good for the individual.
2. How to effectively get buy-in without sounding like a used car salesman.

In this panel session come and discuss with current Directors their insights and lessons learned on their road to becoming Directors and the unique challenges for this role.  If you are currently a Director or striving for this position in your career trajectory this panel will help inform you on how they handle supporting and empowering their leaders, teams and faculty and how to successfully forge partnerships with different stakeholders in your organization.  The panelists are a diverse group of leaders from different organizations that will be able to provide a wide range of  Research Administration experience and look forward to helping others be successful in the field. 

Content Level: Intermediate

Learning Objectives:
1. Discuss strategies to balance the more global Director level tasks with the needs of our teams and faculty.
2. Get best practice insights to tackle the unique challenges of being a leader of leaders and how to empower your team.

Speaker(s):
Maria Hernandez, Director, Center Business Operations, Seattle Children's Research Institute; Courtney Holbert, CRA, Director of External Funding, The University of Tennessee,  Rachel Kinney, CRA, JD, Director, Research Administration and Sponsored Programs, High Point University; Dara Little, CRA, Associate Vice President for Research/Executive Director Sponsored Programs, Northern Illinois University

1. Learn how to manage stress with project management tips and tricks that can be applied to both grant management and personal needs.
2. Practice constructive communication and determine proactive responses to balancing workload and prioritizing self-care.

1. Use UofL’s program as a model to increase understanding of the complex NIH-NRSA programs and to reduce the institution’s risk of non-compliance.
2. Use UofL’s program as a model to create and streamline business processes across the institution, and to support the delivery of a world class biomedical training program.

With regulatory and compliance oversight being a large administrative burden for clinical trial cancer care institutions, how does an institution ensure research regulations are met while delivering efficient care to patients? Being de-centralized means, we are responsible for our success, failure and everything in between. This session will touch on the recent challenges and successes over the past 2 years where the TriHealth Cancer Institute Research program shifted from a centralized to de-centralized organization and how regulatory and compliance processes had to meet the new institutional structure.

Content Level: Basic

1. Communication, Communication, Communication... how to communicate effectively to all stakeholders both internally and externally.
2. How to navigate through the possible pitfalls when the buck starts and stops with you regarding regulatory and compliance for all studies within your department.

1. Create a proposal budget in accordance with the Cost Principles and based on solicitations.
2. Transfer the proposal budget entries into NIH Modular budget and/or DOE budget formats.

The most common compliance finding for federal grant recipients is a failure to adequately document the time and effort of the grantee’s personnel. This session will focus on examples of enforcement actions against universities and institutions facing alleged time and effort reporting violations. What prompts enforcement authorities to investigate and what can institutions do to mitigate risk and harm if subject to an investigation? By reviewing a handful of examples, this session will provide guidance on best practices going forward.

Content Level: Basic

Learning Objectives:

1. Understand the types of time and effort reporting violations that cause enforcement authorities to open an investigation or bring charges.
2. Develop best practices for their institutions based on the examples provided.

Speaker(s):
Rosie Dawn Griffin, JD, Counsel, Feldesman Tucker Leifer Fidell LLP; Minday Pava, JD, Counsel, Feldesman Tucker Leifer Fidell LLP

This session will cover new developments related to proposal and award policy at NSF. NSF staff will provide a comprehensive review of NSF’s recent policy changes and updates to NSF’s proposal system modernization efforts.

Content Level: Basic

Speaker(s):
Beth Strausser, Senior Policy Specialist, National Science Foundation

• Changes to travel/conferences and implications for outreach
• Proposal evaluator crisis
• New challenges in engaging researchers from under-represented groups
• Agency reorganizations

1. Raise awareness of new and not yet resolved challenges associated with running a basic research program.
2. How research administrators and researchers can develop practices to develop practices to aide in meeting those challenges.

This session will provide practical advice and tools to help Pre-Award RAs lay the groundwork for a proposal's smooth transition to the Post-Award team.  From reviewing the proposal to assessing the key elements of the award - terms & conditions, sub-awards, compliance, intellectual property, etc. - we'll cover elements essential to the successful management of the award life-cycle.

Content Level: Basic

Learning Objectives:

1. To understand key post-award requirements to inform pre-award review of the proposal.
2. To develop an appreciation of the pre-award role in the post-award phase of the sponsored project life-cycle.

Speaker(s):
Kim Carter, Associate Vice President for Research, Executive Director, Office of Sponsored Projects Administration, University of Kentucky; Krys Lynam, Senior College Grant Officer, Office of Sponsored Projects Administration, University of Kentucky Research Foundation; Ella Christiansen, Office of Sponsored Projects Administration, University of Kentucky Research Foundation 

It is scientifically and ethically imperative for researchers to understand it is a key commitment to our research participants to report the results of the clinical trials, so that we can advance knowledge and make informed medical decisions about health care. This session will discuss the most recent federal mandates, requirements, and enforcement of clinical trials disclosure, as well as updates and best practice identified in the research community. The presenter will share the approach that Rutgers’ Human Research Protection Program (HRPP) has taken to establish an effective program, identify key issues and facilitate investigators to maintain compliance with clinical trials registration and results reporting at their institution. 

Content Level: Intermediate

Learning Objectives:

1. Describe why clinical trials disclosure matters and list resources to assist investigators in maintaining compliance.
2. Identify how to establish a system in your organization to facilitate and monitor clinical trials registration and results reporting.

Speaker(s):
N. Rebecca Chen, MS, MEd, CCRP, Human Subjects Protection Senior Analyst & ClinicalTrials.gov Administrator, Rutgers, The State University of New Jersey

Ever wonder where new requirements come from? Discussion on development of policy and legislation into requirements. How do the newest initiatives affect research funding. How best to align internal policies with new requirements.

Content Level: Basic

Learning Objectives:

1. Gain a deeper understanding of the policy process for requirements.
2. Gain insight into recent and emerging policy and legislative changes to funding requirements.

Speaker(s):
Mike Shannon, Vice President Government Solutions, IPTalons

Going from centralized to a de-centralized post pandemic finance department restructuring. How a discipline leaves the nest and spreads their wings to soar. Why managing revenue and expenses is so important in a clinical research environment. We will discuss the ups and downs of navigating from a centralized to de-centralized finance department.

Content Level: Intermediate

Learning Objectives:

1. The importance of Financial Reconciliation and Analysis - In order to tell the story and providing a realistic picture of a financial study for collections and billing.
2. Identifying barriers and resolutions to issues before they become catastrophic so that the PI has access to vital financial information regarding their studies.

Speaker(s):

Jason Claes, MBA, MSM, GRCRA, Oncology Clinical Research Manager, TriHealth, Inc.; Billie Cook, AS, Clinical Trials Financial Specialist, TriHealth, Inc.

As a leader, one of your many responsibilities is to identify and develop future leaders within your organization. Succession planning is an essential tool to ensure your organization retains the necessary knowledge and skills to help your organization smooth and steady transfer of knowledge and to maintain critical functions and relationships, regardless of who comes and goes. 

Content Level: Intermediate

Learning Objectives:
1. Understanding the importance of a succession plan for your organization. 
2. Tips on how to implement a succession plan. 

Speaker(s):
Gloria Greene, CRA, MA. Assistant VP Contracts and Grants, The University of Alabama in Huntsville; Gina Hedberg, Executive Director, Office of Sponsored Projects Administration, University of South Alabama

This interactive session will discuss what the "new world of work" looks like for individuals in research administration and why it will be different for every individual. We will discuss how technologies like automation, robotics, and artificial intelligence are shaping how we work, where we work, and the skills and education we need to work.

Content Level:  Basic

Learning Objectives:

1. Gain a sense of how they can prosper in this new world of work and have the work/life balance that works for their lifestyle.
2. Understand there is no step-by-step instructions as this new world of work is a culture and leadership attitude change. It has to happen bottom up and top down and is unique to each company and to each individual.

Speaker(s):
Gloria Greene, MA, CRA, Assistant Vice President, Contracts and Grants, The University of Alabama in Huntsville; Anita Mills, MA, CRA, Director of Enablement, University of Tennessee Space Institute - Huntsville; Debbie Pettitt, Sr. Grants Management Officer, National Institute of Health

1. Analyze the factors impacting feasibility assessment of clinical research.
2. Cite case study scenarios and mechanisms to determine scientific merit. Financial review of timelines, targets and cost.

This interactive session will explore the ongoing struggles Research Administrators face daily. Are you constantly being asked for balances, reports and documents? Are you able to engage PIs to be self-service? Is your process for certifying time efficient?  Attendees will interact to discuss what has worked  for them to improve post award processes.  Whether you experience these struggles or have already conquered them, please join us so we can learn together during this interactive and informative session. 

Content Level: Basic

Speaker(s): 
Ana Hagendorf, Professional Services Consultant, Cayuse; Dee Salmon, Customer Success Manager, Cayuse

1. Understand the consequences of failing to comply with foreign support and other support reporting obligations.
2. Employ best practices to ensure their research institution can mitigate similar risk associated with such investigations and cases.

Many research administrators have moved into new leadership or management roles at the department level and stepped into what sometimes appears to be a disaster by finding non-compliant practices, inefficient workflows and the lack of sound post-award and financial management practices. Gut instinct is to rush to the Director or high-level leadership, but without proper tactics and preparation, this could create unnecessary conflict, tension with team members and could potentially cause the director to have hesitation in building trust with the new incumbent. While the new role may be at mid-management level and can have several years of research administration experience, rushing to judgement without listening to the team and leadership to understand and acknowledge why the ways things are can prevent operations from changing and improving. This session will demonstrate through discussion and role playing the do’s and don’ts of communicating department level business operations issues and how to approach the team and leaders to form a consensus and followership for the desired changes.

Content Level: Intermediate

Learning Objectives:

1. How to convey to leadership and/or team members the need to kickstart process change and improvement to move forward and “be better”.
2. How becoming an effective listener will better prepare you to communicate effectively the need for change and/or delivering bad news.

Speaker(s):
Amanda Seymour, CRA, Senior Associate, Attain Partners; Nadezhda Kikilo, Senior Manager, Attain Partners

In March of 2020, when organizations sent staff home because of the Pandemic; no one could have predicted the length or the profound impact this would have long term on how organizations operated.  Organizations are grappling with establishing new norms and what lessons were learned from being thrust into a remote work environment. Leaders have choices to make that will impact whether their institution is seen as an employer of choice or not.  The Pandemic forced us to adapt to the remote environment on the fly and what helped us to survive a crisis may need examining given the current reality where some are forced back into the office and other organizations are struggling with a hybrid workforce, some completely remote.  While challenges abound, there are still opportunities for maximizing the functionality in our technology solutions to help us work smarter while maintaining some semblance of work/life balance for ourselves and our staff.  This interactive session will allow time for sharing of current challenges and opportunities faced by participants and to hear perspectives from leaders who have both a federal, academic and medical vantage point.  Bring your questions! 

Content Level: Intermediate

Learning Objectives:
1. Articulate to senior leadership who allocate institutional resources why employee retention is critically important toward building a professional workforce that can provide effective and efficient support of the research enterprise.
2. Develop effective strategies for addressing the challenges facing research administration offices while maximizing the benefits derived for the opportunities afforded our profession.

Speaker(s):
Sandra Garcia, CRA, Ed.D., Assistant Vice President OSPA, University of Texas San Antonio; Patrick Shirdon, MS, Chief Operating Officer, National Institute of Health

The Great Resignation brought about immense change and challenges within the world of research administration, particularly in the ways that we work and what our teams need to succeed. Retention and recruitment easily moved to the top spots for issues facing employers. Not only can turnover affect the moral of your office, but it can also be very costly. This session will focus on what we can do as research administrators and managers to help alleviate these issues.

Content Level: Basic

Learning Objectives:

1. Learn the factors motivating people to leave their jobs.
2. What you can implement at your institution to improve recruitment and retention.

Speaker(s):
John Hedberg, CRA, Senior Associate, Attain Partners; Dara Little, Assistant Vice President for Research and Sponsored Programs, Northern Illinois University

1. Explore ways to minimize the burden of 2 CFR 200 requirements. Recognize additional requirements for risk assessment and monitoring, and understand documentation obligations for monitoring.
2. Review of FFATA reporting requirements.

Session would provide an overview of the various tasks that are involved with faculty transfers and touch on each of these tasks with guidance on how to resolve these so you can be prepared and work closely with your faculty to ensure a smooth transition whether they are outgoing or incoming.

Content Level: Basic

Learning Objectives: 

1. Successfully assist faculty coming into their institution with their grant transfers and help the faculty to setting up their research program at the new institution.
2. Assist outgoing faculty with closing out and preparing their research to transition to another institution.

Speaker(s):
Sandra Garcia, CRA, Ed.D., Assistant Vice President OSPA, University of Texas San Antonio; William Hoffman, Jr., MAS, Research Administrator, University of Maryland, Baltimore; Debbie Pettitt, Sr. Grants Management Officer, National Institute of Health; Janet Simons, Director, Research Policy and Training Export Officer, Sponsored Programs Administration University of Maryland, Baltimore; Artisha Wright, Compliance Section Chief, National Institute of Health

A review of research security requirements, policy changes and legislative initiatives. Explanation of best practices and industry leading tools and methods to identify, manage and remediate risk of conflicts of interest while instilling trust and accountability for compliance.

Content Level: Intermediate

Learning Objectives:

1. Be aware of recent and emerging policy and legislative requirements associated with research security.
2. Articulate critical elements of a Research Security Program, including tools and methods of addressing risk.

Speaker(s):
Mike Shannon, Vice President Government Solutions, IPTalons

1. Distinguish between contract and accounting billing and invoicing terms.
2. Create a term sheet that lists acceptable billing and invoicing terms.

This panel session will explore some of the unique issues that Clinical Trial Directors face in their day-to-day work. This diverse panel of leaders have strong backgrounds in Research Administration and will focus on the issues that make supporting clinical trials and clinical study teams so complex. If you currently support clinical trials or are looking to make the jump from another specialty into clinical research, join this panel as they discuss their personal experiences in building clinical programs and their best practices for harmonizing the finances, regulations, partnerships and personalities associated with clinical research. Come discuss the serious, bizarre and sometimes funny issues and leave with strategies and tips for when you face these issues in the future.

Content Level: Intermediate

Learning Objectives:
1. Learn about the unique and complex issues associated with supporting clinical trials.
2. Discuss best practices and solutions that Clinical Trial Directors need to develop to successfully support clinical trials.

Speaker(s):
Jason Claes, MBA, MSM, GRCRA, Manager Oncology Research, TriHealth, Inc.; Maria Hernandez, Director, Center Business Operations, Seattle Children's Research Institute; Kevin Titus, MBA, Sr. Business Director, Cincinnati Children's Hospital

There is a difference in work from home opportunities and employing staff who are 100% remote, sometimes in separate time zones. Seattle Children's Research Institute has been utilizing totally remote staff from remote locations for two years. Initially hires could only be made from selected states but SCRI is now piloting a program to allow hiring from any US state. Recruiting employees to work in a complex research administration environment proved to be easier than retaining those employees who lacked connection to the research and local colleagues. The first "summit" was held this past fall bringing all remote members on site for a three day training and team building exercise. While that represented a significant investment by the institute, balanced against the high cost in terms of restaffing and PI satisfaction, the investment has paid dividends in terms of staff retention. Representatives of the Center Business Operations (CBO) unit which provides direct support to PIs in seven centers will offer insights on how its rebuilding efforts are transitioning toward a long term strategy for staff development and retention. Additionally, strategies for building trust among members of the CBO leadership team most of whom were new employees will be shared.

Content Level: Basic

Learning Objectives:

1. Formulate strategies to enhance remote and hybrid team and leader engagement.
2. Justify the need for investments in professional development of remote employees.

Speaker(s):
Maria Hernandez, Director, Center Business Operations, Ben Towne Center for Childhood Cancer Research (BTCCCR), Seattle Children’s Research Institute

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

Content Level: Basic

Learning Objectives:

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

Alex Weekes, Principal, ML Weekes & Company, PC

1. Understand how funding has expanded and realize the mechanisms available for your organization to contribute.
2. Understand how an NIH Institute plans, prioritizes and executes its resources to achieve scientific investments.

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 distinction between a sponsored program grant and a philanthropic gift.

Speaker(s):
Kevin Titus, MBA, Sr. Business Director, Cincinnati Children's Hospital Medical Center

The Departmental or College-Level Research Office plays a crucial role in all aspects of research administration. Staff must have expertise in many areas, including pre- and post-award, compliance, sub-recipient monitoring, among others. Department/college research administrators work closely with a diverse group of individuals ranging from faculty to sponsored programs staff to accounts payable. This session will discuss key components of building a research office and the skills required to effectively manage research.

Content Level: Basic

Learning Objectives:

1. Understand the role of a departmental research office and the relationships with various institutional entities.
2. Apply best practices in pre-award administration and post-award management to support daily operations and research investigators.

Speaker(s):
Beth Cammarn, CRA, Senior Research Operations Manager, University of Texas Medical Branch

In this panel session come and discuss with current Directors their insights and lessons learned on their road to becoming Directors and the unique challenges for this role.  If you are currently a Director or striving for this position in your career trajectory this panel will help inform you on how they handle supporting and empowering their leaders, teams and faculty and how to successfully forge partnerships with different stakeholders in your organization.  The panelists are a diverse group of leaders from different organizations that will be able to provide a wide range of Research Administration experience and look forward to helping others be successful in the field.

Content Level: Intermediate

Learning Objectives:
1. Discuss strategies to balance the more global Director level tasks with the needs of our teams and faculty.
2. Get best practice insights to tackle the unique challenges of being a leader of leaders and how to empower your team.

Speaker(s):
Kim Carter, Associate Vice President for Research, Executive Director, Office of Sponsored Projects Administration, University of Kentucky; Ella Christiansen, CRA, MBA, Director, Office of Research - College of Health Sciences, Boise State University; Farida Lada, PhD, Chief Campus Compliance Officer, University of California San Francisco; Krys Lynam, Senior College Grant Officer, Office of Sponsored Projects Administration, University of Kentucky Research Foundation

The pandemic prompted us to alter many aspects of our personal and professional lives and we were met with challenges never experienced before. Now, three years later, things have gone somewhat back to normal. While many employers adopted permanent remote or hybrid work environments, many others are now requesting employees return to the office. This presents new challenges, but also new opportunities. This session will discuss real-world scenarios and strategies to optimize your current work environment and help strengthen your team.  

Content Level: Basic

Learning Objectives:

1. Employ useful strategies related to self-management, team management, and communication and will gain a better understanding of different challenges and opportunities facing teams and individuals in various work environments.
2. Help make effective adjustments to their current work situations that will benefit both themselves and their team.

Speaker(s):
Beth Cammarn, CRA, Senior Research Operations Manager, University of Texas Medical Branch

Shared resources are essential to appropriately support diverse and dynamic research programs while avoiding unnecessary redundancy and waste. Significant capital resources are required to support shared services. Establishing mechanisms to support capital demands to sustain core facilities at the local site can be a challenge. Traditional models for Core facilities are readily established along service lines for flow cytometry, microscopy/imaging, and various other service lines supporting clinical research operations. However, as research departments and institutions grow the implementation of more adaptive models may be necessary to ensure sustainability for both planned and emergent growth in capacity, service line specificity, and utilization demand.  Particularly, the growth of biobanks and data management demands in Core spaces presents new challenges in maintaining protections to both physical specimens as well as research patients’ protected health information (PHI). Newer strategies may benefit from balancing availability of biobanks as Core resources with the imperatives of actively managing the mechanisms and pathways for restricting access.  A key element to establishing models for biobanking and data management is ensuring appropriate availability and protection for PHI and data assets.            

Content Level: Intermediate

Learning Objectives:
1. This session will highlight and explore several considerations for access including  internal/external controls; PHI protections; staff training, cybersecurity, and coordinating operations between site stakeholders. The evolutionary advantage of transitioning informal shared resources into more formal programmatic models is increased structure and clarity on overall performance metrics. Potential challenges may be transactional costs that will impact local administrators, investigators, and larger research community alike.
2. This session will share insights on strategies for change management, data security, and shared governance as programmatic considerations to operationalizing adaptive shared services models able to accommodate growth, changing patterns in utilization demands, and greater sustainability for Core services at the local site. The session will highlight presenter’s experiences initiating COVID-19 tissue biobanking as well as leading a biorepository site for “All of Us” the largest biobanking initiative in US history.
3. The session will benefit research administrators of Core facilities and shared service programs looking to navigate operational considerations for biobank security and PHI data protections.                                       

Speaker(s):
André Watkins, Assistant Professor of Health Care Administration, Mayo Clinic College of Medicine and Science

Research Development (RD) is an integral part of the research enterprise at universities, colleges, and medical and research institutions. As important as the RD function is to institutions, there is some confusion as to what RD is and isn't. This panel will discuss the importance of the practice and will provide attendees with a forum to explore and discover the many RD activities they may already be doing at their institutions. The panel will also share ideas and examples of best practices and other professional development avenues to increase skills in this area.

Content Level: Basic

Learning Objectives:

1. Gain a basic understanding of Research Development (RD) practices and activities.
2. Describe Research Development (RD) within their own context or institution.

Speaker(s):
Jose Alcaine, PhD, CRA, MBA, Director of Research Services/Affiliate Faculty in Foundations, Virginia Commonwealth University; Kimberly Pratt, MA CRA, Sponsored Programs Manager, Ohio University ORSP; Heather Russell-Simmons, University of Kentucky, Proposal Development Officer; Mariquita Boone, University of Memphis, Pre-Award Coordinator

This session provides an opportunity to learn what is new and what is 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. Participants will also 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 much more. 

Content Level: Basic

Speaker(s):
Ashley Alexander, PhD, Grants Policy Specialist, Division of Grants Policy (DGP), Office of Policy for Extramural Research Administration (OPERA), National Institute of Health

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.

Speaker(s):

Kevin Titus, MBA, Sr. Business Director, Cincinnati Children's Hospital Medical Center

Have you ever turned around and looked back the way you came? How did you get from lab research assistant to the operations director or a student intern to a contracts director? Isn’t it amazing to see where you were five years ago or 10 years ago in your career? What do you see when you look toward the horizon? What is your goal for your career? Perhaps you are an assistant director wanting to take the next wrung on the ladder. Maybe you are a new supervisor tasked with building a specialty team you will direct. Maybe you are a brand new to the field of research administration and you are wondering where this career can take you. In this forum, the members of the panel, all current directors, are going to chat about their career paths, the right choices they made, and some things that may have hindered them. We are also going to discuss some standard education and work experience that facilitate promotions into director positions. This is an open forum discussion, so we are looking forward to learning about your experiences as well and building our networks.

Content Level: Intermediate

Learning Objectives:

1. Identify experiences that furthered the career of current directors.
2. Learn about work experience that improves promotability into director positions.
3. Gain new members to your professional network (Bring your business cards!)

Speaker(s):

Kimberly Read, PhD, CRA, Director, Director, Business & Research Administration, University of South Florida; Amanda Seymour, CRA, MBA,  Senior Associate, Attain Partners; Stephanie Stone, JD, Director - Contracting, Mass General Brigham Inc,

1. Understand the critical generational and personality differences shaping the workplace.
2. Identify tools to be successful in celebrating and differences to achieve desired goals.

Laurel Long, BBA (Accounting), MSHRM, Associate Vice President, Human Resources, University of Alabama in Huntsville

This session will provide a high-level overview of the prior approval requirements as described in the Uniform Guidance (2 CFR Part 200) and the NIH Grants policy statement. It will include 40-minutes of interactive case studies that emphasize the importance of CRA and AOR collaboration to ensure timely and complete prior approval request submissions.

Content Level: Intermediate

Learning Objectives:

1. Understand the NIH prior approval process, submission requirements and discern whether an action requires or does not require NIH prior approval.
2. Establish strategies, best practices, and/or SOPs for timely and complete prior approval request submissions. (AORs) Identify common mistakes in prior approval requests before submitting for consideration.

Speaker(s):

Debbie Pettitt, Sr. Grants Management Officer, National Institute of Health; Artisha Wright, Lead Other Transactions Authority Agreement Specialist, National Institutes of Health; Teri Pailen, Supervisory Grants Management Specialist, National Institutes of Health 

Clinical trials must comply with the Good Clinical Practice guidelines (GCP). Unfortunately, the GCP is not well defined. This session will review the Department of Health and Human Services, Food and Drug Administration, and major international regulations and guidelines, as well as other institutions governing clinical research. Participants will learn how the actions of regulatory agencies affect budget development, contract negotiations and the way studies are conducted. Topics will include the ethical origins of the GCP, historic milestones and their regulatory significance, and discussion of best practices to enhance regulatory compliance.

Content Level: Basic

Learning Objectives:

1. Participants will learn how the actions of regulatory agencies affect budget development.
2. Participants will gain knowledge in contract negotiations and the way studies are conducted.

Speaker(s):

Kevin Titus, Sr. Business Director, Cincinnati Children's Hospital Medical Center; Tonya Edvalson, Operations Manager, University of Utah; Tonya Edvalson, Operations Manager, University of Utah Health 

1. Identify key features of common electronic proposal submission systems and standard compliance issues relevant to pre-award processes.
2. Describe expectations of major federal electronic submission programs such as Grants.gov, Research.gov, NASA NSPIRES, and Proposal Central.

M. Fran Stephens, CRA, MSgt (USAF, Ret.), Director, Pre-Award Services, Office of Research Services, The University of Oklahoma

The untrained employee is a source of considerable risk. CUI risk awareness teaches and reinforces the basic responsibilities of protecting and reporting security incidents. Safeguarding CUI starts with employees knowing CUI flows through their department.

Content Level: Basic

Learning Objectives:

1. What is CUI?
2. Why is it important?

Speaker(s):

Gloria Greene, MA, CRA, Assistant Vice President, Contracts and Grants, The University of Alabama in Huntsville; Anita Mills, MA, CRA, Director of Enablement, University of Tennessee Space Institute - Huntsville

1. Spark interest to create enhancements and efficiencies within current structural arrangements.
2. Understand the whys behind some structural decisions.

Anthony Cassese, MBA, Senior Consultant, Grants Administration, Attain Partners

1. Understand what proactive steps are needed to ensure compliant closeout.
2. How to create tools for use in closeout.

Meaghan Ventura, MS, CRA, Senior Sponsored Projects Officer, Research Institute at Nationwide Children's Hospital

1. Learn how to conduct a risk assessment.
2. Learn how to mitigate risks through implementing appropriate controls.

Tharanee Ravindran, CIA, CCSA,CRMA and Masters in Accounting, Director of Internal Audit - UAH, University of Alabama System

The success of human research studies lies on the element of trust – trust in investigators and the process they conduct the studies. This session will review the ethical principle, a variety of key points along a “research cycle” of a human research study which include IRB review, post approval monitoring, and the reporting responsibilities. The “active engagement of study participants” will be utilized to separate the 3 stages, i.e. Before, During, and After, in the discussion, in order to enhance the quality of human subjects studies. The conduct of human subject research should be facilitated and monitored through a study’s life cycle, and data of the common audit findings collected from 6 fiscal years will be reviewed.

Content Level: Intermediate

Learning Objectives:

1. Identify the basic components of IRB review, post approval monitoring, and research results reporting.
2. Describe how the ethical principles for the responsible conduct of human subject research are carried through a study’s life cycle.

Speaker(s):

N. Rebecca Chen, MS, MEd, CCRP, Human Subjects Protection Senior Analyst & ClinicalTrials.gov Administrator, Rutgers, The State University of New Jersey; Tonya Edvalson, Operations Manager, University of Utah

1. Understand the components of the RACI project management model.
2. Apply RACI principles to common research administration challenges.