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  • Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 05/20/2026 at 1:00 PM (EDT)

    This introduction to Clinical Research Project Management Workshop incorporates a broad range of skill sets in order to plan, administer, track, evaluate and report on activities involved clinical research process. The goal of this interactive workshop is to introduce, affirm, and enhance the participant’s understanding of project management.

    Goal: This introduction to clinical research project management workshop incorporates a broad range of skill sets in order to plan, administer, track, evaluate and report on activities involved clinical research process. The goal of this interactive workshop is to introduce, affirm, and enhance the participant’s understanding of project management.

    Objective:  Through discussion, presentation, and interaction, this virtual program will broaden the participants’ knowledge of the project management art and science. 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:

    • Describe  skills and responsibilities to move from a clinical research coordinator or other research roles to learn about the responsibilities of a Project Manager.
    • Define key terms and concepts associated with Project Management.
    • Describe project management processes following PMI (Project Management Institute) guidelines (initiation, planning, execution, monitoring, controlling, and closing).
    • Discuss the processes and procedures that are necessary to develop an infrastructure that will support the various tasks associated with Project Management in Clinical Research.
    • Describe Project Management constraints including Scope, Time, Budget, and Performance.
    • Learn about effective strategies in Virtual Project Management and Decentralized Clinical Trials.
    • Discuss basic principles of Risk Management, Risk Avoidance and Risk Mitigation.
    • Learn how Organizational Tools and Techniques can improve effectiveness and maintain quality in project management.
    • Discuss Organizational Dynamics and self-management in project management to promote effective team building.
    • Discuss approaches to work effectively with different leadership styles and organizational cultures.

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

    Nancy Wintering, MSW, LCSW, CCRP

    Nancy Wintering, MSW, LCSW, CCRP (Moderator)

    Assistant Director of Research

    Marcus Institute of Integrative Health at the Thomas Jefferson University

    Nancy Wintering is the Assistant Director of Research at Thomas Jefferson University’s Marcus Institute of Integrative Health and a recipient of the 2022 SOCRA President’s Special Recognition Award. A Licensed Clinical Social Worker with over 30 years of experience, she has overseen Phase I–III research studies and is a strong advocate for patient-centered research and community collaboration.

    A Certified Clinical Research Professional (CCRP) since 2007, Nancy has held multiple leadership roles within SOCRA and served as faculty across several training programs. She is a prolific educator and author, having coauthored over 75 peer-reviewed articles and numerous book chapters, and has mentored nearly 100 student interns. Nancy is dedicated to advancing the clinical research profession through education, mentorship, and improved communication in the informed consent process.

    Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP

    Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP (Moderator)

    Consultant

    Biotech Companies

    Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP has over 30 years of experience having served in roles of increasing responsibility on all sides of the business (academic site, sponsor, CRO, 3rd party vendor) in project management, clinical operations, operational excellence, outsourcing and other related areas. She has significant experience in multiple therapeutic areas including oncology, immunology and rare diseases. She is PMP-certified, is an ASQ-certified black belt as well as has a CCRP certification through SOCRA.

    Currently she is a consultant working with biotech companies strategically in different aspects of project management, clinical operations, process excellence and outsourcing. Prior to this, she was Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative, a non-profit organization partnering with multiple drug manufacturers and academic sites to run large platform studies studying new therapies for breast cancer and other therapeutic indications. She manages multiple groups including clinical operations, monitoring, drug safety, drug management, site regulatory as well as quality. Prior to this role, she was Senior VP, Program Management, overseeing clinical trial operational aspects as well as patient advocacy for an ultrarare pediatric indication. Prior to that, she was VP, Project Delivery at Strategikon where her team ensured project management and consultative services for successful clinical trial planning, budgeting and outsourcing. She also has worked in project management and clinical operational roles at Connect Biopharma, Astex and Jazz. Prior to this she was Executive Director, Clinical Operations and Project Management at Rainier Therapeutics where she not only served as the global lead on several studies, but also led project management across all functions. Prior to Rainier Therapeutics, she was Senior Director of Clinical Outsourcing, Operational Excellence and Project Management at Dynavax where she oversaw relationships with all clinical vendors as well as led multiple infrastructure process improvement initiatives. Prior to Dynavax, she spent several years at Covance, where her most recent position was Executive Director, Alliance Management. In this role, she was responsible for overall global program and portfolio management for several pharmaceutical/biotech sponsor clients holding ultimate accountability for successful delivery of clinical trials that Covance runs for these clients. Prior to this, at the Immune Tolerance Network, UCSF, she was Senior Director, Clinical Operations where her department oversaw 30+ clinical trials in the areas of transplantation, T1 diabetes, allergy, MS, and other autoimmune disorders. Dr Sivaramakrishna also served on the board of SOCRA for several years and is on the project and program management faculty for SOCRA’s conferences.

    She was invited by UC San Diego Extensions to develop a course on project management in clinical trials which has been running since 2017

  • 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

    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

    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

    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

    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.

    Christine Baker

    Christine Baker (Moderator)

    Senior Regulatory and Compliance Officer

    The Ohio State University

    Christine Baker is the Senior Regulatory and Compliance Officer for the Center for Neuroimaging, Neurophenotyping, Neurocomputation and Neuromodulations (C4N), Department of Psychiatry and Behavioral Health at The Ohio State University. She has spent more than 20 years in the field of clinical research, leading a regulatory, compliance and training team at large pediatric academic medical center, writing policy and creating training programs for all members of the clinical research team. After years of writing consent forms for clinical trials, she is very interested in the area of health literacy. Christine spends her free time cheering on the Columbus Blue Jackets NHL team, traveling with her husband and relaxing with a good book.

  • 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

    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

    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 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

    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

    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

    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

    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

    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

    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

    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.