Virtual Research Administration Conference - Thursday Sessions

In the bustling world of academic research, where time, resources, and funding are always in high demand, harnessing the power of research dashboards can be a game-changer. Implementing research dashboards provides a valuable tool for optimizing research funding utilization, identifying areas of improvement, and making data-driven decisions. In this presentation, we will describe the development and implementation of research dashboards with the ambitious goal of optimizing research funding utilization, enhancing collaboration opportunities, and identifying areas for improvement. Research funding utilization improved significantly as PIs gained a better understanding of their budget allocation and expenditure patterns. The dashboards served as a catalyst for identifying areas of improvement, enabling administrators to reallocate resources efficiently. 

Content level: Intermediate

Learning objectives:

1. Understand the benefits of dashboards as a tool to monitor and optimize research resources and funding
2. Develop a roadmap to implementing a dashboard in a department

Track: Administration and Management 

Speaker(s): Lara Landry, Director, Research Operations, Baylor College of Medicine; Ketti Eipers-Smith, Grant Program Manager, Baylor College of Medicine; My Le Dong, Data Analytics Associate, Baylor College of Medicine; Rashad Mohammed, Director of Business Operations, Baylor College of Medicine 

In 1996, when NIH adopted the Just-In-Time (JIT) process for awarded proposals. For decades, NIH was the sole user of JIT, but in more recent years, other agencies are employing the same process before issuing award paperwork. This session will explore what can be considered JIT requests with different sponsors and how to gather the information quickly and accurately to ensure a fast award issuance. This session will also explore future regulatory changes that will impact JIT processes.

Content level: Basic

Learning Objective: 

1. Attendees will become familiar with the different information and documents required at the Just-in-Time process for NIH but also for other federal agencies, who have recently adopted similar processes. Tips for quick information gathering and processing sponsor requests before an award is made will be shared by all participants. 
2. Attendees will learn of new and future regulatory changes that may require action just-in-time of award or even before submission deadlines. Institutions will have their own procedures, but information exchanged will help those attending to know what changes may be required of them or their PI(s).

Track: Pre-Award

Pre-Award Certificate: Elective

Speaker(s): Kristen Geiger, Assistant Director, Sponsored Research Administration, Carnegie Mellon University

You have an Export Compliance Program…but is it right-sized for your research center or institution? We’ll discuss ideas to consider when tailoring the recommended compliance program elements from BIS and DDTC to truly fit your organization’s risk, culture, and operations.

Content level: Intermediate

Learning objectives:

1. Understand federal government recommendations for a comprehensive export compliance program
2. Learn the key factors that drive tailoring your export compliance program to fit your institution or research center.

Track: Compliance and Ethics

Speaker(s): Jennifer Saak, Managing Director, Traliance LLC

Description coming soon!

Track: Clinical and Translational Research 

Speaker(s): TBA

In this session, attendees will gain knowledge of cost share and the importance from both the pre-award and post-award aspects. We will dive into when and why institutions cost share. What should we take into consideration as we budget, monitor and report cost share to the sponsor.  In addition to the basics, other key areas of concern will be discussed include: allowability of expenditures, impact to F&A rate and communication.

Content level: Basic

Learning objectives:

1. Review the different types of cost share and cost share contributions. 
2. Discuss  how to proactively manage cost to avoid future problems.  

Track: Finance

Pre-Award Certificate: Elective

Speaker(s): Maria Soliman, Director, Grant Accounting, University of Iowa

In this session, the speakers will shepherd attendees through the learning journey of defining powerful partnerships, offer pivotal insight in how to be a good mentor/coach/advocate, and provide roadmaps to excellence as a mentee/employee or individual/protégé. This session will also offer meaningful context to assist attendees in selecting the right powerful partnership based on their extensive experience as forward leaning thought leaders in research administration. 

Content level: Basic

Learning objectives:

1. Ignite introspection and discuss a comprehensive leadership plan.
2. Review how to define and participate in powerful partnerships as a mentor or mentee.

Track: Professional Development 

Speaker(s): Thomas Spencer, Associate VP of Research Operations, University of Texas Rio Grande Valley; Sheleza Mohamed, National Director, Government Grants Administration, American Heart Association

We sometimes speak a totally different language than our investigators.  Whether you are trying to communicate with a central office, department, division, or investigator, you must tailor your message to the recipient.  In this session, we’ll provide our recommendations for best practices and how to navigate communication with all individuals that rely on research administration for success!

Content level: Intermediate 

Learning objectives:

1. Clarify best practices for communications with all research administration stakeholders.
2. Identify and implement the tools needed to create department-specific guides and forms. 

Track: Administration and Management 

Speaker(s): Laura Sheehan, Manager of Research Administration, University of California, Los Angeles; Jeff Derr, Sponsored Research Manager, California Institute of Technology, Rady Rogers, Associate Director for Research Administration and Finance, Harvard University

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

Content level: Basic

Learning objectives:

1. Knowledge of the many levels of investigator and institutional compliance.

2. A framework for guiding investigators to successful proposal activities.

Track: Pre-Award

Pre-Award Required: Pre-Award Preparation for Post-Award Success (PA-III)

Speaker(s): Renee Vaughan, CRU Financial Practice Manager, Duke University

This session will provide an overview of common information privacy and security requirements we may see in research contracts; including introductions to laws and regulations on information privacy and security that may impact research. The session will explore some common controls that are available to help address these requirements and provide ideas around how research administrators can work with their institution IT units to ensure these requirements are met.

Content level: Intermediate

Learning objectives:

Track: Contract Law

Speaker(s): Dan Han, Chief Information Security Officer, Virginia Commonwealth University

This session will provide an overview of current federal requirements for conflicts on interest in research, including institutional and individual conflicts of interest and developing requirements addressing conflicts of commitment. 

Content level: Basic

Learning objectives:

1. Identify key federal requirements for conflicts of interest.
2. Understand a conflict of interest assessment in human subjects research.

Track: Compliance and Ethics

Speaker(s): Amber Moore, Conflict of Interest Program Manager, University of South Florida 

Track: Clinical and Translational Research 

Clinical Trials Research Administration Required: Rules and More Rules (CTRA-R)

Speaker(s): Lisa Weaver, Clinical Research Manager, University of Utah Health

Creating a unified and effective team in a hybrid and bi-coastal setting requires nurturing a robust team culture that goes beyond geographical boundaries and ensures consistent communication among different time zones. In this session, senior-level research administrators will share their insights and methods for recruiting, onboarding, mentoring, and encouraging collaboration within a pediatric healthcare system and research institution. The provided resources, including various forms and tools, are versatile and adaptable for use in numerous research administration contexts and can be tailored to work for diverse team structures.

Content level: Intermediate

Learning objectives:

1. Participants will learn effective strategies and best practices for building and managing a cohesive, productive team in a hybrid and bi-coastal work environment.
2. Participants will receive a comprehensive toolkit, including a variety of forms and handouts, designed to facilitate and enhance team development within their organizations.

Track: Professional Development 

Speaker(s): Maria Hernandez, Director, Center Business Operations, Seattle Children's Research Institute; Nicola Barnes, Seattle Children's Research Institute

All research administrators know what an audit is, but an audit is often limited to the policies and procedures related to the handling of expenditures and conformance with accepted financial standards. An assessment however looks at both financial and administrative structures and can provide focus on concepts not covered by an audit, such as program efficiency. This presentation will discuss the basic structure and concepts an institution could use in creating their own assessment.

Content level: Advanced 

Learning objectives:

1. Understand the difference between an audit and an assessment. 
   
2. Understand what is needed to run an institutional assessment.

Track: Administration and Management

Speaker(s): Sean Scott, Founder, 720 Consulting LLC; Kim Carter, Associate Vice President for Research Executive Director, Office of Sponsored Projects Administration, University of Kentucky; Dara Little, Associate VP for Research/Executive Director Sponsored Programs, Northern Illinois University

As a research administrator you are often consulted on agreements for sponsored research. You process many instruments as awards to your institution that you are required to review. Are you able to properly advise your PI or do you turn to legal counsel? Research Administration has many different agreements that are necessary for the day-to-day interactions between an investigator and a sponsor. This session will explain the use different agreements.

Content level: Basic

Learning objectives:

1. Know the different agreements and be able to explain when and why they are used.

2. Be able to suggest agreements to protect the Institution and PI’s research and intellectual property.

Track: Pre Award

Pre-Award Required: Award Review and Acceptance  (PA-IV)

Speaker(s): Karen Mitchell, Assistant Vice President, Research Administration, Temple University; Germaine Calicat, Grants and Contract Specialist,  Temple University

This session will present on tips to developing soft skills when negotiating with a variety of sponsors (Federal, state, non-profits, for-profits). Topics will include intellectual property rights, indemnification, confidentiality, governing law and more.  In this session we will also present tips for how to use basic negotiation skills as a research administrator to dissect more complex language within an agreement to further develop your negotiator skills. 

Content level: Intermediate

Learning objectives:

1. Learn soft skills when negotiating with a variety of sponsors (Federal, state, non-profits, for-profits
2. Negotiation tips for how to use foundational negotiation skills to dissect complex language for mitigating compliance

Track: Contract Law

Speaker(s): Hilda Vasquez, Research Policy Manager, University of California; Melissa Waver, Research Policy Manager, University of California 

This is applicable for all studies (i.e., investigator initiated, industry funded, foundation funded or federally funded). The goal is to ensure sufficient interest in the study design and research questions. Not just doing a study to do a study. The next steps are ensured that there are proper resources (i.e., study staffing including coordinators, investigators, research assistants; Institutional Review Board (IRB) and contract review teams, statisticians, etc.) to conduct the study; proper facilities (access to investigational pharmacy; inpatient or ambulatory facilities, etc.) and equipment (centrifuge, freezers, access to specified MRI or CT equipment); and sufficient and proper patient populations. Ensure that the budget will cover the cost of implementing the study (i.e. training of staffing, procedures, screening costs, development of CRFs, efforts of data transfers, monitoring, start-up costs, indirect, etc.) Determining the proper mechanism for scientific review to ensure validity of the research questions. Access to legal review through the grants and contracts team.

Content level: Intermediate

Learning objectives:

1. Is the study answering relevant research questions through rigorous methodologies?
2. The ability to analyze the legal, fiscal, ethical and scientific review of clinical trials to ensure that you are choosing the right studies for your site.
3. Is this study helpful to your patient populations (i.e. are you meeting the clinical goals important to
   your medical environment).

Track: Clinical and Translational

Clinical Trials Research Administration Required: Determining Study Feasibility at Your Site 

Speaker(s): Amy Bartlett, Associate Director, Clinical Research Development, The Ohio State University

This session will help participants fully understand clinical research from the industry perspective. The major components of the pharmaceutical industry are traditional pharmaceutical companies, stand-alone biotechnology companies, and biopharmaceutical companies that represent a melding of traditional and biotechnology approaches to discovery. In addition, there are medical device companies that, again, are either stand-alone entities or into larger pharmaceutical companies. The session will cover the industries issues with timelines, quality and cost. The presenter will provide an overview of the clinical trial protocol development process and clinical study conduct. Pharmaceutical drivers for study site selection will be highlighted. Site-based contracts, including budgets, publication rights, intellectual property, and subcontracting issues will also be discussed. 

Content level: Basic

Learning objectives:

1. Provide pharmaceutical industry perspective in the drug development process and an overview of the steps in drug and device development.
2. Allow participants to have an overall understanding of the issues that drive the clinical trial process and clinical trial negotiations with sites and investigators.

Track: Finance

CTRA REQUIRED: Clinical Trials: The Industry Perspective (CTRA-R)

Speaker(s): J. Michael Slocum, President, Slocum & Boddie, PC