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  • Contains 3 Component(s), Includes Credits Includes a Live Web Event on 05/08/2026 at 9:00 AM (EDT)

    Clinical research in pediatric populations must follow the same regulations that adult clinical research follows, yet there are additional safeguards for children in clinical research, challenges associated with consent and study management for families and nuances in these populations that we don’t experience in the adult clinical research community. When you engage a child for participation in a clinical research program, you are engaging the entire family. Parents have a different risk/benefit profile for their child than they do for themselves. Navigating this complex environment with compassion, integrity and processes that embed compliance into every interaction are critical to protecting this vulnerable population and ensuring we can bring the best treatments forward as quickly as possible. Whether you're just getting started in pediatric clinical research or you have decades of experience, this program is designed to elevate your understanding and application across the regulatory environment, informed consent and assent, recruitment and retention, feasibility, budgeting, contracting and financial management with compliance tips and tricks along the way. Our goal with this interactive conference is to share lessons learned from experienced pediatric clinical research professionals but more importantly, understand the challenges or questions each conference attendee is facing and weave content and engaging discussions around those challenges so that each attendee walks away with the knowledge and the tools they need most.

    The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. Clinical research in pediatric populations must follow the same regulations that adult clinical research follows, yet there are additional safeguards for children in clinical research, challenges associated with consent and study management for families and nuances in these populations that we don’t experience in the adult clinical research community. When you engage a child for participation in a clinical research program, you are engaging the entire family. Parents have a different risk/benefit profile for their child than they do for themselves. Navigating this complex environment with compassion, integrity and processes that embed compliance into every interaction are critical to protecting this vulnerable population and ensuring we can bring the best treatments forward as quickly as possible. Whether you're just getting started in pediatric clinical research or you have decades of experience, this program is designed to elevate your understanding and application across the regulatory environment, informed consent and assent, recruitment and retention, feasibility, budgeting, contracting and financial management with compliance tips and tricks along the way. 

    LEARNING OBJECTIVES

    • Discuss ethical considerations when conducting clinical research in the pediatric population
    • Discuss guidelines to writing research informed consent and assent documents
    • Discuss how to adequately review the protocol and source documents, list the documentation needed, discuss how to identify obstacles that may occur and the importance of communication amongst the study teams during study start up
    • Discuss special considerations for developing pediatric research study budgets including a review of "hidden costs"
    • Discuss monitoring and auditing issues specific to pediatric research
    • Discuss the compliance challenges associated with conducting clinical trials and one site’s strategy to address this challenge


    Please contact us with any questions or concerns at education@socra.org

    Grace Wentzel (Moderator)

    Deputy Director

    State of Ohio Adversity and Resilience (SOAR)

    Grace Wentzel is Deputy Director, State of Ohio Adversity and Resilience (SOAR) and also serves as the Regulatory and Compliance Lead for the Center for Neuroimaging, Neurophenotyping, Neurocomputation and Neuromodulations (C4N). Prior to her current role, Grace spent over 30 years building and implementing centralized research infrastructure programs and services at a large pediatric academic medical center and an integrated research organization. Grace is dually certified with SOCRA and HCCA and continues to be heavily focused on leadership, strategic planning, policy development, patient access and engagement and training and education for clinical research professionals. Grace loves to spend as much time as she can with her grandson, family and their charcoal lab at their lake house, boating, watching the sunset and reading a good book

    Jessica Fritter, DHSc, MACPR, ACRP-CP, FACRP (Moderator)

    Associate Clinical Professor

    The Ohio State University

    Dr. Jessica Fritter is an Associate Clinical Professor at The Ohio State University, College of Nursing and Director of the Master of Clinical Research, Clinical Research Management Graduate Certificate and Clinical Trials Sciences Undergraduate Certificate programs where she teaches and creates courses that are fundamental to clinical research education. She is Co-Director of Workforce Development at The Ohio State University Clinical Translational Science Institute and Faculty Director of the Multisite Trial Coordinating Center. Through her years in clinical research, she has overseen very robust and always evolving infrastructures and has managed multimillion dollar infrastructures and clinical trial budgets along with overseeing regulatory affairs, clinical research training, compliance, business operations, clinical trial management systems, feasibility, and program management. As a leader in clinical research workforce development, Dr. Fritter directs national and local initiatives that enhance education, training, and professional identity within the field. Her national leadership includes leading working groups within the Association of Clinical Translational Science Clinical Research Professional Special Interest Group (SIG) focused on team science and workforce retention, resulting in publications and national presentations. She is committed to early pipeline development, having co-founded the Next STEPP Clinical Research Summer Camp for high school students. Dr. Fritter’s advocacy work has contributed to national recognition of clinical research careers, and presentations to students and professionals to promote the field. She holds leadership roles in the Consortium of Academic Programs in Clinical Research and the Association of Clinical Research Professionals and is a board member of Association of Graduate Regulatory Educators (AGRE). As PI, she leads a national study on the impact of academic training on certification outcomes and is PI of a study assessing employer and clinical research professionals’ perceptions on credentials. She has presented at major conferences and mentored numerous professionals, supporting the next generation of clinical research leaders.

    Laura Adkins, MAP, CCRP, CCRA (Moderator)

    Director, Office of Research Regulatory Affairs (ORRA)

    University of Arkansas for Medical Sciences

    Laura Adkins, MAP, CCRP, CCRA is a seasoned clinical research professional with almost 24 years of experience in the field. She has dedicated her career to advancing clinical trials and strengthening research operations within an academic health center, improving processes, and ensuring trials are conducted ethically with integrity, quality, and participant safety at the forefront.

    Laura holds a Master of Applied Psychology (focus on Industrial/Organizational psychology) and certifications through the Society of Clinical Research Associates (SOCRA) as a Certified Clinical Research Professional (CCRP) and the Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Associate (CCRA).

    Laura plays an active role in professional education through SOCRA, serving on the National Board of Directors and as Co-Chair of the Arkansas Chapter. She is passionate about equipping researchers at all levels with the knowledge and resources they need to succeed and believes strongly in the power of shared expertise to strengthen the research community.

    She currently serves as Director of the Office of Research Regulatory Affairs, which acts on behalf of the University of Arkansas for Medical Sciences as sponsor for FDA-regulated research involving Investigational New Drugs and Investigational Device Exemptions. In this role, Laura oversees multiple units, including Regulatory Affairs, Monitoring, Quality Assurance, Good Tissue Practice and ClinicalTrials.gov. She fully understands that these trials are “labors of love” for local researchers and appreciates the passion that they have for their projects.

    In all aspects of her career, Laura is dedicated to protecting research participants and supporting investigators in conducting ethical, compliant, and high-quality studies. She is committed to mentoring researchers and helping them and their teams navigate an increasingly complex regulatory environment and values the opportunity to collaborate on projects that produce reliable data and advance medical innovation.

    Cristina Ferrazzano Yaussy (Moderator)

    Director, Research Quality and Training

    Dartmouth Health

    Cristina Ferrazzano Yaussy, MPH, CCRP, is an experienced research compliance and quality professional with demonstrated expertise in clinical research oversight within academic health systems and industry. Her work centers on strengthening regulatory compliance frameworks, advancing quality assurance programs, and promoting the ethical and responsible conduct of human subject's research.

    Cristina holds a Master of Public Health (MPH) from Case Western Reserve University and is a SOCRA Certified Clinical Research Professional (CCRP) and has comprehensive knowledge of Good Clinical Practice (GCP), federal regulations, and research compliance requirements. She has extensive experience advising investigators and research teams on regulatory strategy, audit preparedness, corrective and preventive action planning, and risk mitigation. Her approach integrates regulatory rigor with practical operational insight to support high-performing, compliant research programs.

    In her leadership role within the Dartmouth Health Office of Research Operations, Research Quality and Safety, Cristina oversees internal audit and monitoring activities, provides regulatory consultation for Sponsor-Investigator research and ClinicalTrials.gov, and directs the development and implementation of policies, procedures, and training initiatives that enhance research quality and participant protections. She works closely with institutional stakeholders to foster a culture of accountability, transparency, and continuous improvement. Additionally, she also serves on the Board of Directors for the Society of Clinical Research Associates (SOCRA). Through her strategic leadership and collaborative engagement with the greater research community, Cristina advances efforts to safeguard participants, strengthen compliance infrastructure, and promote excellence in clinical research. Cristina has direct experience supporting research sites in regulatory interactions, including audits and inspections conducted by the U.S. Food and Drug Administration. She is committed to ensuring that research programs maintain the highest standards of integrity while effectively navigating complex regulatory environments.

  • Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 04/28/2026 at 8:30 AM (EDT)

    This virtual symposium is a distinct opportunity for Sponsor-Investigators and key research staff to receive targeted training directly from FDA, NIH, and research industry representatives. It will provide insight into the unique dual-role of sponsor-investigators with in-depth coverage of the applicable FDA regulations, guidelines, and best practices. Attendees will take away tools for designing and managing quality research studies that will produce accurate and complete data submissions. The two (2) full-day schedule allows for less disruption to clinical practice and continuing education credits (CME/CNE/SOCRA CE) apply.

    This virtual symposium is a distinct opportunity for Sponsor-Investigators and key research staff to receive targeted training directly from FDA, NIH, and research industry representatives. It will provide insight into the unique dual-role of sponsor-investigators with in-depth coverage of the applicable FDA regulations, guidelines, and best practices. Attendees will take away tools for designing and managing quality research studies that will produce accurate and complete data submissions. The two (2) full-day schedule allows for less disruption to clinical practice and continuing education credits (CME/CNE/SOCRA CE) apply.

    Please contact us with any questions or concerns at education@socra.org. 

    Dates:

    Tuesday April 28th and Wednesday April 29th, 2026.

    Time:

    8:30 am EST to 4:00 pm EST

    *All times in Eastern Standard Time Zone

     Registration:
    • Standard Rate - Member Fee - $600
    • Standard Rate - Non-Member Fee *- $675

    * Non-Member Fees include a discounted one-year SOCRA membership.

    Continuing Education Credit: 

    SOCRA designates this educational activity for a maximum of 11.75 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 11.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Accreditation Statements:

    CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

    CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation.

    SOCRA Course Series: 700

    Please contact us with any 

    questions or concerns at education@socra.org.

    Jessica Rowe, MA, MS,CCRP,CIP (Moderator)

    Quality and Education Director

    Yale Cancer Center Clinical Trials Office

    Jessica Rowe, MA, MS, CCRP, CIP, is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office. Previously, she served as the Associate Director for Regulatory, Compliance, and Quality at the Yale Center for Clinical Investigation (YCCI) and the Yale Human Research Protection Program (HRPP). Before her tenure at Yale, Jessica was the HRPP Director for WellSpan Health, where she managed a comprehensive human research protection program.

    Jessica has an extensive 13-year background at the University of Maryland, Baltimore (UMB), where she held multiple roles in the research field and was an active member of several research review committees. She continues to contribute as an IRB member for both UMB and Yale, and she chairs the Southern Pennsylvania SOCRA Chapter while also serving as the Immediate Past President of SOCRA.

    Jessica is an adjunct instructor at the University of Maryland, Baltimore Graduate School, teaching courses in research compliance and administration. She is a recognized faculty member in several SOCRA workshops, including Quality Management and the GCP Prep Course.

    With extensive experience in human subject research compliance, IRB, quality, clinical trial management, education, and training, Jessica is a Certified Clinical Research Professional (CCRP) and a certified IRB Professional (CIP). She also holds a graduate certificate in Research Ethics from the University of Maryland, Baltimore. Her passion lies in human subject protections, bioethics, quality, and compliance.

    Alyssa Gateman, MPH, CCRP (Moderator)

    Executive Director, Yale Cancer Center Clinical Trials Office

    Yale Cancer Center Clinical Trials Office

    Alyssa Gateman currently serves as the Executive Director of the Yale Cancer Center Clinical Trials Office. Since joining Yale in July 2014, she has also held the role of Senior Associate Director of Quality Assurance and Research Regulatory Initiatives at the Yale Center for Clinical Investigation. Prior to her time at Yale, Ms. Gateman was Director of the Quality Assurance Office for Clinical Trials at Dana-Farber/Harvard Cancer Center. 

    Ms. Gateman is deeply committed to advancing the clinical research workforce through education and mentorship. In addition to her long-standing involvement with SOCRA, she serves as Adjunct Faculty at Southern Connecticut State University, where she teaches Good Clinical Practices and Clinical Trial Administration as part of the Healthcare Studies undergraduate program. A dedicated SOCRA member, she will celebrate 22 years of membership and 19 years of certification in 2025. She is a former SOCRA Board member, frequent presenter for SOCRA and currently serves as the inaugural President of the Connecticut SOCRA Chapter. 

    Outside of work, Ms. Gateman enjoys supporting the Yale Junior Bulldogs hockey team as a coach’s wife and goalie mom, and spending time with her golden retriever, Biscuit. 

  • Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 04/22/2026 at 12:00 PM (EDT)

    This interactive virtual workshop will be facilitated by clinical research professionals with a combined industry experience of more than 20 years. The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination through a GCP review. This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice, including the ICH Guidelines and FDA Regulations that govern clinical research practice.

    Goal: The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination. 

    This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice including the ICH Guidelines and FDA Regulations that govern clinical research practice.

    Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Please contact us with any questions or concerns at education@socra.org.

    Learning Objectives: Upon completion of the workshop, the attendee should be able to:

    • Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
    • Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
    • Explain the drug/biologic development process
    • Describe the device development process
    • Outline concepts for Good Clinical Practice (GCP)
    • Explain the elements of informed consent
    • Describe the membership and reporting requirements of IRBs
    • Explain rules relating to financial disclosure
    • Discuss the basics of study design
    • Explain the rules and reporting requirements for adverse events and serious adverse events
    • Explain study closure procedures and record retention guidelines
    • Outline the reasons for monitoring, audits and site visits
    • Explain the Food and Drug Administration rules, regulations, and guidelines on research
    • Discuss the importance of investigational drug accountability
    • Demonstrate and describe how to read clinical reports and records
    • Discuss Quality Assurance including, Monitoring and Auditing
    • Explain issues that would constitute clinical fraud

    The purchase of this course is optional. It is not required to sit for or pass the CCRP certification exam. Purchasing and completing this course will not guarantee a passing score on the CCRP certification examination.

    Please contact us with any questions or concerns at education@socra.org.

    Laura Holtz, MS, CCRP (Moderator)

    Senior Research Manager

    Laura R. Holtz, MS, PMP, CCRP, is a Senior Quality Specialist at Yale University, Yale Cancer Center, Clinical Trials Office. Previously, she was a senior project manager at the Indiana University Center for Aging Research on federally- funded randomized control trials and demonstration programs to provide care collaboration for patients with dementia and their caregivers in multiple care settings. She also coordinated an annual statewide conference focused on palliative and end-of-life communication and research. She shares her expertise in regulations, informed consent, decision making capacity, patient/caregiver interviewing, ethics, and research project management at numerous local and national conferences. Laura established the Indianapolis chapter of Society of Clinical Research Associates (SOCRA) and organizes education opportunities which provide pathways for staff to become Certified Clinical Research Professionals. She is a co-facilitator for the SOCRA Clinical Site Coordination/ Management and Good Clinical Practice (GCP) workshop and the Certified Clinical Research Professional (CCRP) and GCP Exam Prep course. As the SOCRA President, she contributes to the organization’s strategic objectives to provide research education, networking opportunities and professional credentialing for the research community. Laura has a Master of Science in Communications from Purdue University. 

    Katrina A. Croghan, M.S., CCRP (Moderator)

    Program Director of Applied Clinical Research Program

    St. Cloud State University

    Katrina Croghan serves as the Program Director of the Applied Clinical Research Program at St. Cloud State University (SCSU), where she leads a curriculum focused on providing comprehensive, industry-driven knowledge to prepare students for successful careers in clinical research. She also holds the position of Quality Management Coordinator (QMC) at the Mayo Clinic Comprehensive Cancer Center (MCCCC), overseeing the establishment, maintenance, and education related to all MCCCC documentation, policies, and procedures.

    Ms. Croghan earned both her B.S. and M.S. degrees from SCSU and has been a Certified Clinical Research Professional (CCRP) since 2014, accredited by the Society of Clinical Research Associates (SOCRA). She joined the Applied Clinical Research Program at SCSU as adjunct faculty in 2023 and has been with Mayo Clinic since 2012. Her professional journey in clinical research began within the Department of Medicine—Clinical Research Office, later expanding to the Cancer Center in 2015. There, she held roles such as Certified Clinical Research Coordinator (CRC), Lead CRC, and Senior CRC, before advancing to her current QMC role.

    In recognition of her expertise, Ms. Croghan attained the rank of Assistant Professor at SCSU in 2025 and was named Assistant Professor of Health Care Administration at Mayo Clinic in 2023. In addition to her primary responsibilities, she co-chairs the SOCRA Southeast MN Chapter and was recently appointed to the SOCRA Board of Directors for the 2025-2028 term.

    Jessica Rowe, MA, MS,CCRP,CIP (Moderator)

    Quality and Education Director

    Yale Cancer Center Clinical Trials Office

    Jessica Rowe, MA, MS, CCRP, CIP, is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office. Previously, she served as the Associate Director for Regulatory, Compliance, and Quality at the Yale Center for Clinical Investigation (YCCI) and the Yale Human Research Protection Program (HRPP). Before her tenure at Yale, Jessica was the HRPP Director for WellSpan Health, where she managed a comprehensive human research protection program.

    Jessica has an extensive 13-year background at the University of Maryland, Baltimore (UMB), where she held multiple roles in the research field and was an active member of several research review committees. She continues to contribute as an IRB member for both UMB and Yale, and she chairs the Southern Pennsylvania SOCRA Chapter while also serving as the Immediate Past President of SOCRA.

    Jessica is an adjunct instructor at the University of Maryland, Baltimore Graduate School, teaching courses in research compliance and administration. She is a recognized faculty member in several SOCRA workshops, including Quality Management and the GCP Prep Course.

    With extensive experience in human subject research compliance, IRB, quality, clinical trial management, education, and training, Jessica is a Certified Clinical Research Professional (CCRP) and a certified IRB Professional (CIP). She also holds a graduate certificate in Research Ethics from the University of Maryland, Baltimore. Her passion lies in human subject protections, bioethics, quality, and compliance.

  • 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 9 of the 10 questions. There is one bonus question at the end. 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 9 of the 10 questions. There is one bonus question at the end. 

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

    This recertification module focuses on recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products.

    **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 3 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.

    Start Date: 12/22/23

    Termination Date: 12/22/26

    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 3 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.

    Start Date: 12/22/23

    Termination Date: 12/22/26

    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 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.

    Start Date: 12/22/23

    Termination Date: 12/22/26

    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 3 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.

    Start Date: 12/22/23

    Termination Date: 12/22/26

    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.

    Start Date: 12/22/23

    Termination Date: 12/22/26

    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

    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.

    Start Date: 12/22/23

    Termination Date: 12/22/26

    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.