Concurrent Sessions

Monday, May 13, 2019 - 10:00 am to 12:00 pm

Research Enterprise Systems Implementation - Panel Discussion

Moderator: Coming Soon!

Room: Class of '49 Auditorium (HH230)

A panel of college and university leaders from several institutions will present on the trials and triumphs of large-scale implementation projects including software systems, process improvement, organizational restructuring, etc. Each leader will present an overview of their project, followed by audience participating in building a simulated project implementation plan.

Monday, May 13, 2019 - 1:30 pm to 2:45 pm

M101 - Preparing for Institutional Audits

Room: Class of '49 Auditorium (HH230)

Presenter(s): James Clavin, BS, University of Pennsylvania; Stephanie Magee, BS, University of Pennsylvania; and Alicia Nalewajek, BA, University of Pennsylvania

In this session, we will discuss the different types of audits, review the audit life cycle, the role of departmental and central administrators, audit red flags and common audit findings. We will also discuss the process and practice of drafting and implementing corrective actions. Participants will be invited to share their experiences regarding best practices they may have adopted and/or witnessed when managing an award to ensure a successful audit experience and outcome.

Content Level: Basic/Intermediate

Learning Objectives:

  1. Participants will learn about the various types of audits and the audit life cycle.
  2. Participants will better understand their role in the audit process.
  3. Participants will be able to identify some of the most common audit findings.
  4. Participants will discuss real examples of audit findings and evaluate solutions.

M102 - Developing Leadership Skills

Room: Ben Franklin Room (HH218)

Presenter(s): Timothy Schailey, MS, Thomas Jefferson University

Today's leadership landscape is dynamic with an unpredictable plethora of regulations and budgetary restrictions. Research Administrators and Clinical Supervisors, namely those in administrative and management roles, need a wide range of operational, relational and analytical skills to effectively carry out their responsibilities. This session will provide information on being effective leaders, doing their jobs well and identifying how leadership skills can directly affect the quality of the performance of staff.

Content Level: Intermediate

Learning Objectives:

  1. Define the traits of effective leadership; how to approach leadership proactively.
  2. Describe methods of assessing various leadership styles; how to effectively apply leadership principles as a research administrator and/or clinical supervisor.

M103 - A Systemic Approach in Maintaining Compliance

Room: Golkin Room (HH223)

Presenter(s): Niem-Tzu "Rebecca" Chen, MS, Med, CCRP, Rutgers, The State University of New Jersey; and Cheryl Forst, RN, BSN, CCRP, Rutgers, The State University of New Jersey

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 the knowledge and make informed medical decisions about health care. This session will discuss the most recent federal mandates and requirements of clinical trials disclosure and the best practice. The presenters will share the approach of Rutgers, The State University of New Jersey, to establish an effective program for clinical trials registration and results reporting at their institution. Rutgers' Human Subjects Protection Program (HSPP) has taken a proactive approach to identify key issues and facilitate investigator compliance within ClinicalTrials.gov records through the HSPP website and continued education, training and monitoring.

Content Level: Intermediate

Learning Objectives:

  1. Describe why clinical trials disclosure matters and the key issues of building up an effective program.
  2. Identify how to establish a system in your organization to facilitate and monitor clinical trials registration and results reporting.
  3. List resources and tools to assist investigators and organizations in maintaining compliance for clinical trials disclosure.

Monday, May 13, 2019 - 3:00 pm to 4:15 pm

M104 - Export Controls and Foreign Influence

Room: Class of '49 Auditorium (HH230)

Presenter(s): Elizabeth Peloso, BS, MSE, MBA, University of Pennsylvania; and Jessie Buchanan, PhD, University of Pennsylvania

Over the past year, the federal government and funding agencies have become increasingly concerned about foreign influence and its impact on grantees. Both the National Science Foundation (NSF) and the National Institutes of Health (NIH) have reminded the grant community of the need to disclose foreign collaborators and foreign sources of support in grant applications and progress reports. One way in which to identify and mitigate the potential risk of foreign influence is by understanding export control regulations and how they relate to academic research and activities.

Content Level: Basic

Learning Objectives:

  1. Develop a basic understanding of the US export control laws and the concept of a deemed export.
  2. Understand "foreign influence issues."
  3. Obtain tools to assist with compliance at your institution.

M105 - Departmental Administration: Maximizing the PI Interface

Room: Ben Franklin Room (HH218)

Presenter(s): Jim Riley, CRA, SHRM-SC, University of Pennsylvania; and Eric Witze, PhD, Associate Professor of Cancer Biology, University of Pennsylvania

While we've spent periods of our career in a variety of central and school-level roles, our experience in research administration has largely been spent working closely with PI's in a departmental capacity. We have found the close contact with PI's to be rewarding, inspiring and truly collaborative. As larger institutions frequently have multiple layers of research support offices, it can be challenging to maintain this close connection across all levels. Understanding the PI's needs, what drives them, how they consume information and what makes their lives easier are key to building a successful support office. Gaining insight into the things they struggle with, as each strives to run what amounts to their own small business, can help bolster the understanding of how the various SME offices dovetail with the research at the ground level. We have presented the department administrator as a combination of financial planner/analyst, budget specialist, transaction manager, personnel manager, frontline compliance officer, purchasing agent, first-tier regulatory support, etc.. In this session, we will explore how all of these rolls intersect with the PI, their lab staff and central offices.

Content Level: Basic

Learning Objectives:

  1. Offer insight into the needs of a PI in building and sustaining a successful lab.
  2. Presenting best practices to facilitate information exchange between PI's, their department administrators and central staff.
  3. Building an atmosphere of customer service to maximize a PI's mission-oriented effort.

Presenter(s): Bryan Sweet, CRA, Temple University

Clinical research is vital to the goals of improving patients' quality of life, patient survival and the ultimate goal, search for a cure. With the number of industry sponsored clinical trials on the rise an integral part of clinical research is the costs associated with conducting clinical trials and the ability to accurately justify costs allowing the sponsor to fund the project appropriately while having all costs covered.

A successful clinical trial is inclusive of a budget that adequately meets the financial needs for conducting the trial. While focus of this session will be mainly the budgetary portion of industry sponsored clinical trials, it should be noted that other compliance issues (IRB approval of the protocol and consent forms) essential in clinical studies should be resolved in conjunction with the budget process.

Content Level: Basic

Learning Objectives:

  1. Understand the essential requirements to putting together a clinical research budget.

M106 - Essential Budgeting Requirements for Conducting Clinical Research

Presenter(s): Bryan Sweet, CRA, Temple University

Clinical research is vital to the goals of improving patients' quality of life, patient survival and the ultimate goal, search for a cure. With the number of industry sponsored clinical trials on the rise an integral part of clinical research is the costs associated with conducting clinical trials and the ability to accurately justify costs allowing the sponsor to fund the project appropriately while having all costs covered.

A successful clinical trial is inclusive of a budget that adequately meets the financial needs for conducting the trial. While focus of this session will be mainly the budgetary portion of industry sponsored clinical trials, it should be noted that other compliance issues (IRB approval of the protocol and consent forms) essential in clinical studies should be resolved in conjunction with the budget process.

Content Level: Basic

Learning Objectives:

  1. Understand the essential requirements to putting together a clinical research budget.

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