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  • Contains 5 Component(s), Includes Credits

    Discuss the importance of good documentation at clinical investigator sites including facts regarding regulatory inspection findings

    Ms. Croghan will discuss the importance of good documentation at clinical investigator sites including facts regarding regulatory inspection findings, what’s the purpose of source documentation, definitions of source data and source documents, good documentation principles.

    At the completion of the webinar, participants should be able to:

    What are source documents?
    Common Source documents and what to address while creating source documents
    How Case Report Forms (CRFs) and source documents can reduce deviations and other protocol identified gaps

    Katrina A. Croghan, M.S., CCRP

    Quality Management Coordinator- Research | Assistant Professor of Health Care Administration

    Mayo Clinic Comprehensive Cancer Center: Cancer Clinical Trials Office

    Katrina Croghan is a Quality Management Coordinator (QMC) for the Mayo Clinic Comprehensive Cancer Center (MCCCC) focusing on the enterprise Quality Management System for MCCCC; which includes the establishment, maintenance, and education of all MCCCC documentation, policies, procedure and etc. She has also been a significant contributor to multiple training and orientation opportunities within MCCCC, including a Principal Investigator (PI) Boot Camp for new investigators, the MCCCC Orientation course for new study team staff and recently implementing a continued education program for current study team staff. Katrina holds a B.S. and M.S. from State Cloud State University in St. Cloud, Minnesota and became a Certified Clinical Research Professional (CCRP) in 2014. Katrina has been with Mayo Clinic since 2012 and started her career as an Assistant Clinical Research Coordinator (ACRC) under the Department of Medicine- Clinical Research Office. She has been with the MCCCC since 2015 and has held Certified Clinical Research Coordinator (CRC), Lead CRC and Senior CRC prior to moving into the QMC role. Outside of Mayo Clinic, Katrina is the co-chair for the SOCRA Southeast MN Chapter since 2022; and has recently (2023) become an Adjunct Professor at St. Cloud State University, under the Applied Clinical Research Program.

  • Contains 3 Component(s), Includes Credits

    This learning module is intended to encourage the reader to maintain an understanding of current activities involved in the conduct of research involving human subjects. The module offers one SOCRA continuing education credit to those who complete the review and correctly answer 8 of the 9 questions. The module is offered at no cost as a public service. This recertification module focuses on diversity in clinical trials. Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. **This module does not work in Internet Explorer at this time**

    This learning module is intended to encourage the reader to maintain an understanding of current activities involved in the conduct of research involving human subjects. The module offers one SOCRA continuing education credit to those who complete the review and correctly answer 8 of the 9 questions.

    The module is offered at no cost as a public service.

    This recertification module focuses on diversity in clinical trials.  Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. 

    **This module does not work in Internet Explorer at this time**

    Upon completion of this course, the attendee should be able to discuss recent issues, changes, and/or updates in the regulatory environment.

    SOCRA's Education Committee

    on behalf of Society of Clinical Research Associates, Inc

    SOCRA's Education Committee has created this module to help clinical research professionals stay updated on recent changes in the regulatory environment.

  • Contains 5 Component(s), Includes Credits

    You may happen to work with a colleague or a direct report who is difficult to please. They may have a special opinion and never want to compromise or they may think they are always right and everyone else is wrong. They want to do things their own way and poor you if you obey. Being snappy and arguing can be their norm, at the same time they still can perform very well. The speakers will share approaches and methods to manage difficult employees, including corrective and preventive measures, supported by real-life examples.

    You may happen to work with a colleague or a direct report who is difficult to please. They may have a special opinion and never want to compromise or they may think they are always right and everyone else is wrong. They want to do things their own way and poor you if you obey. Being snappy and arguing can be their norm, at the same time they still can perform very well. The speakers will share approaches and methods to manage difficult employees, including corrective and preventive measures, supported by real-life examples.

    OBJECTIVE: Discuss types of difficult employees and how to feel more comfortable working with or managing difficult members of the team.

    Anatoly Gorkun, MD, PhD, Chartered MCIPD

    Senior Clinical Manager

    PPD UK

    Upon graduation from medical school, Anatoly worked as a Scientist at the Research Institute of Hematology where he defended his PhD. Later, Anatoly worked at a Clinical Research Organisation in different roles in Quality Assurance, Clinical Management, and Global Project Management. Later, Anatoly worked as a Senior Manager, Medical Organisation Training & Standards at MedImmune/Astra Zeneca in Cambridge, the United Kingdom. In January 2017 Anatoly joined PPD UK as a Senior Clinical Manager. His responsibilities include line management and development of clinical research professionals, resourcing, and clinical trial oversight. Anatoly is a Chartered Member of the Chartered Institute of Personnel and Development (CIPD) and Certified Trainer in the UK, with the CIPD Diploma in Human Resource Development.

    Hugh Devine, IMIS

    Senior Director

    PPD UK

    Hugh Devine is a Senior Director, Clinical Operations, PPD UK & Ireland. He joined PPD in January 2004, based in Cambridge, United Kingdom. His previous roles were with Boehringer Mannheim, Innovex, Pharmacia, and Pfizer. Hugh is responsible for the Clinical Operations team’s deliverables in the UK and Ireland, managing a team over 200 individuals.

  • Contains 4 Component(s), Includes Credits

    Ms. O’Kelly Phillips will discuss how data collection and management were structured in a large CMS demonstration project involving multiple data sources, including direct input from 40 partnered nursing facilities. Lessons learned throughout the project with attention to best practices for approaching managing projects with complex data structure in investigator-initiated grants and trials will be highlighted.

    Ms. O’Kelly Phillips will discuss how data collection and management were structured in a large CMS demonstration project involving multiple data sources, including direct input from 40 partnered nursing facilities. Lessons learned throughout the project with attention to best practices for approaching managing projects with complex data structure in investigator-initiated grants and trials will be highlighted. (.75 CE)

    OBJECTIVE: Discuss best practices and potential approaches to managing projects involving complex data collection structures.

    Erin O'Kelly Phillips, MPH, CCRP

    Research Manager

    Regenstrief Institute

    Erin is a Research Manager at Indiana University Center for Aging Research and Regenstrief Institute. Her experience in research trials includes translational research in diabetes, and projects aimed at improving the lives of older adults in nursing facilities. Currently, she is the manager of the Data & Analytics team for the OPTIMISTIC program, a Centers for Medicare and Medicaid Services nursing facility quality improvement project. Erin is passionate about data, and holds an MPH in epidemiology from the Indiana University Richard M. Fairbanks School of Public Health.

  • Contains 4 Component(s), Includes Credits

    The FDA allows for charging for investigational products used in clinical research under certain circumstances. The federal regulations also state that participants should be informed of any additional costs that may result from participation in research. Recent “research studies” are using this guidance as a loophole to charge participants for studies that may not create generalizable knowledge. Ms. Oeser will review the ethical issues involved in recent pay-to-participate “research studies” and how these may violate the pillars of respect of persons, beneficence, and justice.

    The FDA allows for charging for investigational products used in clinical research under certain circumstances. The federal regulations also state that participants should be informed of any additional costs that may result from participation in research. Recent “research studies” are using this guidance as a loophole to charge participants for studies that may not create generalizable knowledge. Ms. Oeser will review the ethical issues involved in recent pay-to-participate “research studies” and how these may violate the pillars of respect of persons, beneficence, and justice.

    OBJECTIVE: Discuss concrete tactics that can be used to prevent "firefighting" when project-managing clinical trials.

    Annette Oeser, BS, MLAS, CCRP

    Clinical/Translational Research Coordinator III

    Vanderbilt University

    Annette has worked in clinical research for the past 29 years, primarily in PI initiated studies. She currently works as a Clinical/Translational Research Coordinator III in the Division of Clinical Pharmacology at Vanderbilt University Medical Center. She was certified CCRP in 2004 and has been a member of the Greater Nashville Region SoCRA chapter’s Education Committee since 2007. She obtained her Master of Liberal Arts and Sciences (MLAS) degree from Vanderbilt University in 2011, and completed level 1 of the Vanderbilt Program in Research Administration Development (VPRAD) in 2012.

  • Contains 4 Component(s), Includes Credits

    Ms. Rugloski will provide tips and examples for creating and implementing a Project Team Member Transition/Training strategy to ensure effective and efficient project team member transitions. The session will end with an activity comprised of an interactive mind-mapping (‘brainstorming’) exercise with audience participation.

    Ms. Rugloski will provide tips and examples for creating and implementing a Project Team Member Transition/Training strategy to ensure effective and efficient project team member transitions. The session will end with an activity comprised of an interactive mind-mapping (‘brainstorming’) exercise with audience participation.

    OBJECTIVE: Discuss key elements for inclusion within a project team member transition/training plan.

    Carolyn Rugloski, MSc, CCRP

    Senior Consultant, Lead Project Manager

    FCI Consultants

    Since 2008, she has served in senior project manager positions working for global CROs, MedImmune, UCSF ITN and Duke DCRI. She has dedicated her volunteer time over the years to the training of clinical trial professionals through SOCRA and other educational organizations. Recognized internationally as a Good Clinical Practice (GCP) Trainer and subject matter expert, Ms. Rugloski has consulted and lectured in North America, South America, Europe, and Asia. Ms. Rugloski is a past member of the SOCRA Board of Directors and continues to assist in the development and delivery of SOCRA events.

  • Contains 5 Component(s), Includes Credits

    A study’s protocol must be followed in order to maintain compliance. In order to demonstrate compliance, the study team should implement dynamic documentation that clearly and concisely tells a subject's story of participation in the clinical study. By prioritizing adherence to the protocol and documentation of the subject's experience, the study team will successfully demonstrate compliance and mitigate risk.

    A study’s protocol must be followed in order to maintain compliance. In order to demonstrate compliance, the study team should implement dynamic documentation that clearly and concisely tells a subject's story of participation in the clinical study. By prioritizing adherence to the protocol and documentation of the subject's experience, the study team will successfully demonstrate compliance and mitigate risk. 

    OBJECTIVE: Discuss document creation and maintenance to support procedures described in the IRB-approved protocol.

    Amber Ashley Parker, BA, CCRP

    Research QA Monitor, Office of Research Compliance

    Children's Hospital of Philadelphia

    Amber is currently a Research Quality Assurance Monitor in the Office of Research Compliance (ORC) at the Children’s Hospital of Philadelphia (CHOP). Amber has over a decade of experience in the business and conduct of clinical research as a public relations representative, clinical research coordinator, research associate, and investigator. Her education and professional experience allows her to successfully consult with study teams and various organizations on research initiatives. Amber is currently pursuing a Master’s of Bioethics at the Perelman School of Medicine at the University of Pennsylvania and holds a Bachelors of Arts in Health & Societies, with a concentration in Bioethics & Society from University of Pennsylvania. She also completed a University minor in Health Care Management and Biological Basis of Behavior from the Wharton School of Business and the College of Arts & Sciences at the University of Pennsylvania. Amber is a Certified Clinical Research Professional, by the Society of Clinical Research Associates (SOCRA), and is also an active member of the Regulatory Affairs Professional Society (RAPS).

  • Contains 5 Component(s), Includes Credits

    Identifying common oncology research queries and trends can provide added efficiency in addressing them. Understanding the rationale for these common queries can provide insight into methods by which they can be prevented. Finally, understanding how to successfully resolve queries is a critical skill for the clinical research professional.

    Identifying common oncology research queries and trends can provide added efficiency in addressing them. Understanding the rationale for these common queries can provide insight into methods by which they can be prevented. Finally, understanding how to successfully resolve queries is a critical skill for the clinical research professional.

    OBJECTIVE: Discuss the challenges unique to the “experienced patient” with cancer relapse who is being asked to consider enrolling in a clinical trial.

    Rachel Kingsford, MS, CCRP

    Training and Mentorship Manager

    Huntsman Cancer Institute

    Rachel is the Training and Mentorship Manager for the Clinical Trials Offices at the Huntsman Cancer Institute in Salt Lake City, UT. In this role, Rachel has developed and maintains a comprehensive training program for research staff, centered on local, national, and international regulations. She currently serves as Chair for the Utah SOCRA Chapter. Rachel holds a Master's degree in sociology from Utah State University.

  • Contains 5 Component(s), Includes Credits

    According to Paulo Coelho, “the secret to life is to fall down seven times and to get up eight times”. Resilience, from the Latin “to leap back”, is the process and experience of being disrupted by change, opportunities, stressors and adversity and accessing gifts and strengths to grow stronger. This session examines diverse aspects of resilience or “bounce-back ability” in the workplace including the importance, components and development of resilience. The session also includes a brief assessment of personal resilience as well as how to design a resilience development plan.

    According to Paulo Coelho, “the secret to life is to fall down seven times and to get up eight times”. Resilience, from the Latin “to leap back”, is the process and experience of being disrupted by change, opportunities, stressors and adversity and accessing gifts and strengths to grow stronger. This session examines diverse aspects of resilience or “bounce-back ability” in the workplace including the importance, components and development of resilience. The session also includes a brief assessment of personal resilience as well as how to design a resilience development plan.

    OBJECTIVE: Discuss diverse aspects of resilience or “bounce-back ability” in the workplace and how to design a resilience development plan.

    Barbara van der Schalie, MS

    Senior Clinical Training Manager

    Leidos Biomedical Research Inc.

    Barbara has over twenty-five years of experience in education, with the last twenty-five years focused on outcomes-based adult professional training. She is currently the Clinical Training/Learning and Professional Development Manager at Leidos Biomedical Research, Inc. serving the Division of Clinical Research (DCR) of National Institute of Allergy and Infectious Disease (NIAID), in a Learning and Professional Development role, and is also responsible for the compliance, technical and professional development training for Clinical Monitoring Research Program staff of Leidos Biomedical Research, Inc. Frederick. She has a Bachelor’s of Science in Biology and Chemistry/Secondary Education and a Master’s of Science in Biomedical Sciences with a concentration in Cellular Biology. Barbara has also taught Human Anatomy and Physiology in the Allied Health Program at Frederick Community College since 1993 and is still an active instructor in this program.

  • Contains 5 Component(s), Includes Credits

    The value of implementing preventive quality assurance measures is essential to ensuring research compliance. Significant findings during an inspection or audit can results in damaged reputations, loss of existing or future funding, and impact the confidence of the research team. For a research team to be successful, it is vital they proactively identify risks and implement measures to ensure patient safety and the integrity of the research. This proactive approach provides opportunities for coaching, mentoring, and training in a supportive non-punitive way. Preventive measures can provide confidence within the research team, preventing the crisis mode mentality that often precedes an audit or inspection.

    The value of implementing preventive quality assurance measures is essential to ensuring research compliance. Significant findings during an inspection or audit can results in damaged reputations, loss of existing or future funding, and impact the confidence of the research team. For a research team to be successful, it is vital they proactively identify risks and implement measures to ensure patient safety and the integrity of the research. This proactive approach provides opportunities for coaching, mentoring, and training in a supportive non-punitive way. Preventive measures can provide confidence within the research team, preventing the crisis mode mentality that often precedes an audit or inspection. 

    OBJECTIVE: Understand the value of prevention and how to implement preventive measures.

    Angie Price, MSN, CCRC

    Project Director, Clinical Site Network

    Institute for Advanced Clinical Trials for Children (I-ACT)

    Angie is the Project Director, Clinical Site Network at -ACT for Children. She is overseeing the Children’s Pediatric Improvement collaborative for Clinical Trials & Research, otherwise known as PICTR®. Mrs. Price has over 30 years’ of clinical trials experience. She has been certified in clinical research since 1999. She holds a master’s degree in clinical research administration.