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2019 Agenda

Saturday, September 28, 8:30-9:15                                           

Leadership and Line Management in Clinical Research

Whys and whats of line management through leadership will be discussed using real life examples to show how it can support clinical research and you. 617
Presenter: Anatoly Gorkun, MD, PhD, Chartered MCIPD, Senior Manager, Global Clinical Development, PPD UK

Whys and whats of line management through leadership will be discussed using real life examples to show how it can support clinical research and you. 617

Presenter: Anatoly Gorkun, MD, PhD, Chartered MCIPD, Senior Manager, Global Clinical Development, PPD UK

Track: Training

Saturday, September 28, 9:20-10:05                                          

Workforce Resource Management: Managing Onboarding and Training for Key Functional Area Roles

In today’s fast-paced clinical research industry with heightened expectations of quality and qualified staff, effective on-boarding (beyond company orientation) requires a systematic review and analysis of key functional roles to strategically align and allocate resources for the development of efficient on-boarding practices across the enterprise. Management of resources to effectively meet competing clinical research activities necessitates a quality systems approach. Creating a process of continuous improvement to actively engage and positively impact the organization requires realignment, re-deployment and restructuring. This session reviews methods and analysis practices for deployment of on-boarding and training to include realignment when necessary, based upon organizational needs. 619

Presenter: Erika Stevens, MA, BA, Principal, Recherche Transformation Rapide

Presenter: Liz Wool, BSN, RN, CCRA, CMT, President, Wool Consulting Group Inc.

Track: Training

Saturday, September 28 , 10:50-11:35                                         

Optimizing Personal Communication in the Clinical Research Arena: Passive, Aggressive, Assertive, Which Are We and When?

Collaborative communication with colleagues of all levels is a critical professional skill as the clinical research enterprise expands. This presentation will provide an overview of the aggressive, passive, and assertive communication styles, including characteristics, impact on professional progression, and how it looks in a professional environment as well as an inventory tool that allows the participant to adjust their communication style to support their professional goals. 621

Presenter: Barbara van der Schalie, MS, Clinical Training Manager, Leidos Biomedical Research Inc

Track: Training

Saturday, September 28, 11:40-12:25                                           

From Clinical Trials Poster to Peer-Reviewed Publication 

This session is designed to teach poster presenters how to convert their poster content into a manuscript suitable for submission to a peer-reviewed journal. It is particularly suited for those presenting in the clinical trials track who are inexperienced at composing articles for publication. Dr. Selfe will cover choosing an appropriate journal, structuring the manuscript according to International Committee of Medical Journal Editors (ICMJE) recommendations (i.e., introduction, methods, results, and discussion), finding and using the applicable reporting standard (e.g., CONSORT for randomized controlled trials) as a blueprint to make composing a manuscript with the appropriate content a clear-cut task and attainable goal. 623

Presenter: Terry Selfe, PhD, DC, CCRP, Translational Research & Impact Librarian, University of Florida HSC

Track: Training

Saturday, September 28, 1:40-2:25                                         

Research Investment and Staff Enrichment (RISE) 

A core objective of RISE is to “develop a highly trained, innovative, and skilled workforce” and “legitimize” research staff as a valued and career-worthy pathway. Currently there is no defined advancement strategy, and one’s advancement through existing career pathways is often restricted because of reasons unrelated to merit or knowledge, skills, and abilities.  RISE is a formal mentorship platform to help individuals identify personal strengths and work toward career goals. The result will be a diverse network of knowledgeable and skilled staff dedicated to producing high-quality research. Anticipated benefits are 1) job satisfaction and retention among research staff by providing career advancement guidance and professional development opportunities, 2) demonstrated value of contributions and professional development of research staff, and 3) legitimize research staff careers. 625

Presenter: Gloria Harrington, MBA, LMSW, CCRP, Research Operations Manager, University of Michigan

Presenter: Angela Lyden, MS, Science Coordinator, University of Michigan

Track: Training

Saturday, September 28, 2:30-3:15                                         

Cultivating an Effective Research Team through the Application of Team Science Principles

The technique of team science allows us to draw from theory driven principles to inform how to build an effective and efficient research team.  Inherent in these principles are recognizing team member differences and welcoming diversity in an effort to integrate knowledge to solve complex problems.  Ms. Helm will present the basics of team science and how they may be applied to creating a highly productive research team across the study continuum including research administration, budget developers, investigators, and research coordinators.  The development of mutual trust, a shared vision, and open communication are crucial elements to a successful research team and project. The use of a case study to illustrate this approach will be presented. 627

Presenter: Shirley Helm, MS, CCRP, Manager of Clinical Research Administration, Virginia Commonwealth University

Track: Training

Saturday, September 28, 3:45-4:30                                        

Career Progression in Clinical Research: Transitioning from a CRC to a sponsor CRA

Mr. Boothby will focus on the direct experiences of the what, how, and when to make the transition from CRC to a sponsor CRA. With over 15 years of clinical research experience as both a CRC and a CRA, Mr. Boothby will  provide individuals attending this presentation with a checklist that will act as a roadmap to help make this a smooth transition. 629

Presenter: Thomas Boothby, MSc, CCRP, Clinical Research Associate II, Boston Scientific

Track: Training

Saturday, September 28, 4:35-5:20                                          

How Do You Ensure Clinical Trial Quality in Investigator-Initiated Studies? Training for Research Professionals in Monitoring Concepts!

Establishing and maintaining a rigorous quality management system in clinical trials helps to protect human subjects and ensures data collected is accurate and valid. Monitoring, an essential and routine quality function in industry sponsored trials, is often lacking in investigator-initiated trials conducted in academia. We find that only approximately 65% of investigator-initiated trials are monitored when we poll research professionals locally and nationally. Findings from literature and web-based searches revealed that although numerous GCP training resources are available, most require fees or institutional affiliations. Moreover, many lack the practical approaches to meet the complex requirements of monitoring. To address this gap, the University of Southern California is developing a series of self-study modules that will be readily accessible by all research professionals to be used to establish a pool of research coordinators who can cross-monitor and cross-audit studies they do not coordinate. Ms. Spinrad will share her approach, experience and findings in an interactive session. 631

Presenter: Amelia Spinrad, MS, Regulatory Knowledge Support Administrator, University of Southern California

Track: Training