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DTSTART;VALUE=DATE:20260422
DTEND;VALUE=DATE:20260424
DTSTAMP:20261028T190520
CREATED:20260331T233432Z
LAST-MODIFIED:20260401T205846Z
UID:214-1776816000-1776988799@socra.org
SUMMARY:CCRP Prep and GCP Review Course
DESCRIPTION:Goal\nThe purpose of this workshop is to assist the participant in preparing for the CCRP certification examination. \nThis 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. \nObjective\nThe 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. \nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \nDiscuss the basic requirements necessary to meet the demands of a CRP in clinical practice\nDiscuss the basic components of compliance – Law\, regulation\, guidance\, policy and procedure\nExplain the drug/biologic development process\nDescribe the device development process\nOutline concepts for Good Clinical Practice (GCP)\nExplain the elements of informed consent\nDescribe the membership and reporting requirements of IRBs\nExplain rules relating to financial disclosure\nDiscuss the basics of study design\nExplain the rules and reporting requirements for adverse events and serious adverse events\nExplain study closure procedures and record retention guidelines\nOutline the reasons for monitoring\, audits and site visits\nExplain the Food and Drug Administration rules\, regulations\, and guidelines on research\nDiscuss the importance of investigational drug accountability\nDemonstrate and describe how to read clinical reports and records\nDiscuss Quality Assurance including\, Monitoring and Auditing\nExplain issues that would constitute clinical fraud \nThe 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.
URL:https://socra.org/event/ccrp-prep-and-gcp-review-course-2/
LOCATION:Virtual 
ATTACH;FMTTYPE=image/png:https://socra.org/wp-content/uploads/2026/03/SOCRA_events_featured3.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260428
DTEND;VALUE=DATE:20260430
DTSTAMP:20261028T190520
CREATED:20260331T233814Z
LAST-MODIFIED:20260401T203613Z
UID:216-1777334400-1777507199@socra.org
SUMMARY:FDA Clinical Trial Requirements Regulations\, Compliance and GCP Conference
DESCRIPTION: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. \nPlease note\, this workshop is intended to be interactive. Video attendance is strongly encouraged. Once you register\, you will be able to install and test the appropriate software to ensure your audio and video will work properly during the program. Please be sure to give yourself time to address any technical issues that might arise. Please contact us with any questions or concerns at education@socra.org. \nContinuing Education Credit Hours:\nSOCRA 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. \nAccreditation Statements:\nCME 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.\nCNE 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.\nSOCRA Course Series: 700
URL:https://socra.org/event/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference/
LOCATION:Virtual 
ATTACH;FMTTYPE=image/png:https://socra.org/wp-content/uploads/2026/03/SOCRA_events_featured1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260508
DTEND;VALUE=DATE:20260509
DTSTAMP:20261028T190520
CREATED:20260331T234215Z
LAST-MODIFIED:20260401T205724Z
UID:218-1778198400-1778284799@socra.org
SUMMARY:Pediatric Clinical Trials
DESCRIPTION:This interactive virtual workshop will be facilitated by clinical research professionals with a wealth of industry expertise. The purpose of this workshop is to assist research professionals in improving their skills and their understanding of the responsibilities of conducting clinical research in the pediatric population. This conference provides attendees with new information\, management tools\, and real life examples\, to help participants navigate the evolving landscape of pediatric research. \nContinuing Education Credit Hours\nSOCRA designates this educational activity for a maximum of 6.5 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 6.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. \nAccreditation Statements\nCME 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. \nCNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. \nSOCRA Course Series: 850
URL:https://socra.org/event/pediatric-clinical-trials/
LOCATION:Virtual 
ATTACH;FMTTYPE=image/png:https://socra.org/wp-content/uploads/2026/03/SOCRA_events_featured2.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260520
DTEND;VALUE=DATE:20260522
DTSTAMP:20261028T190520
CREATED:20260331T234349Z
LAST-MODIFIED:20260401T205942Z
UID:219-1779235200-1779407999@socra.org
SUMMARY:Project Management - Beginner 
DESCRIPTION:Goal\nThis 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. \nObjective\nThrough 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. \nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \n\nDescribe  skills and responsibilities to move from a clinical research coordinator or other research roles to learn about the responsibilities of a Project Manager.\nDefine key terms and concepts associated with Project Management.\nDescribe project management processes following PMI (Project Management Institute) guidelines (initiation\, planning\, execution\, monitoring\, controlling\, and closing).\nDiscuss the processes and procedures that are necessary to develop an infrastructure that will support the various tasks associated with Project Management in Clinical Research.\nDescribe Project Management constraints including Scope\, Time\, Budget\, and Performance.\nLearn about effective strategies in Virtual Project Management and Decentralized Clinical Trials.\nDiscuss basic principles of Risk Management\, Risk Avoidance and Risk Mitigation.\nLearn how Organizational Tools and Techniques can improve effectiveness and maintain quality in project management.\nDiscuss Organizational Dynamics and self-management in project management to promote effective team building.\nDiscuss approaches to work effectively with different leadership styles and organizational cultures.\n\nPlease contact us with any questions or concerns at education@socra.org.
URL:https://socra.org/event/project-management-beginner/
LOCATION:Virtual 
ATTACH;FMTTYPE=image/png:https://socra.org/wp-content/uploads/2026/03/SOCRA_events_featured4-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260609
DTEND;VALUE=DATE:20260610
DTSTAMP:20261028T190520
CREATED:20260331T234439Z
LAST-MODIFIED:20260331T234450Z
UID:220-1780963200-1781049599@socra.org
SUMMARY:Monitoring & GCP Workshop - Beginner
DESCRIPTION:
URL:https://socra.org/event/monitoring-gcp-workshop-beginner/
LOCATION:Virtual 
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260616
DTEND;VALUE=DATE:20260617
DTSTAMP:20261028T190520
CREATED:20260331T234601Z
LAST-MODIFIED:20260331T235456Z
UID:221-1781568000-1781654399@socra.org
SUMMARY:CCRP Prep and GCP Review Course
DESCRIPTION:
URL:https://socra.org/event/ccrp-prep-and-gcp-review-course-3/
LOCATION:Virtual 
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260708
DTEND;VALUE=DATE:20260709
DTSTAMP:20261028T190520
CREATED:20260331T234819Z
LAST-MODIFIED:20260331T235453Z
UID:222-1783468800-1783555199@socra.org
SUMMARY:Device Research & Regulatory Information
DESCRIPTION:Join us for a medical device webinar series. The program will feature 3 sessions and 3 experts presenting topics to assist those in roles specific to medical device design\, development\, testing\, analysis\, and post market management. \nContinuing Education Credit Hours:\nSOCRA designates this educational activity for a maximum of 3 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 3 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. \n\nAccreditation Statements\nCME 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. \nCNE 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.
URL:https://socra.org/event/device-research-regulatory-information/
LOCATION:Virtual 
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260730T120000
DTEND;TZID=America/Los_Angeles:20260730T130000
DTSTAMP:20261028T190520
CREATED:20260814T213253Z
LAST-MODIFIED:20260814T213301Z
UID:1830-1785412800-1785416400@socra.org
SUMMARY:San Francisco Bay Chapter: Using AI for Inspectional Readiness: The One Day Pilot or the Routine Inspection
DESCRIPTION:Learning Objectives \n\nExamine how AI can be used to support inspectional readiness for both a one-day pilot inspection or a routing surveillance inspection\nHear real-world perspectives on inspections from using AI in the readiness process.\nExplore the use of AI in responding to FDA\, or other regulatory body\, inspections.\n\nSpeaker: Mr. Eric Pittman
URL:https://socra.org/event/san-francisco-bay-chapter-using-ai-for-inspectional-readiness-the-one-day-pilot-or-the-routine-inspection/
LOCATION:Virtual 
CATEGORIES:Chapter Event
ORGANIZER;CN="Archana Narasanna":MAILTO:socrabayareachapter@gmail.com
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260808
DTEND;VALUE=DATE:20260809
DTSTAMP:20261028T190521
CREATED:20260331T234921Z
LAST-MODIFIED:20260331T235449Z
UID:223-1786147200-1786233599@socra.org
SUMMARY:Site Coordinator Course (include CTMS) 
DESCRIPTION:
URL:https://socra.org/event/site-coordinator-course-include-ctms/
LOCATION:Virtual 
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260813
DTEND;VALUE=DATE:20260814
DTSTAMP:20261028T190521
CREATED:20260331T234955Z
LAST-MODIFIED:20260331T235435Z
UID:224-1786579200-1786665599@socra.org
SUMMARY:Quality Management 
DESCRIPTION:This interactive virtual workshop will be facilitated by clinical research professionals with a wealth of industry expertise. The purpose of this workshop is to assist research professionals in understanding\, developing\, and implementing quality management systems (QMS) in the conduct of clinical trials. This conference provides attendees with new information\, tools\, and real life examples to help participants navigate the components of quality management – quality planning\, quality control\, quality assurance\, and quality improvement. \nContinuing Education Credit Hours\nSOCRA designates this educational activity for a maximum of 9.75 Continuing Education Credits for SOCRA CE and Nurse CNE. \nSOCRA designates this live activity for a maximum of 9.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. \nAccreditation Statements\nCME 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. \nCNE 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. \nSOCRA Course Series: 120
URL:https://socra.org/event/quality-management/
LOCATION:Virtual 
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20260819T110000
DTEND;TZID=UTC:20260819T120000
DTSTAMP:20261028T190521
CREATED:20260814T213724Z
LAST-MODIFIED:20260814T213724Z
UID:1835-1787137200-1787140800@socra.org
SUMMARY:Central Virginia Event: Monitoring :  Oversight with Impact
DESCRIPTION:Learning Objectives \n\nExplain what drives the monitoring process\nExamine monitoring visits\, how to prepare and common findings\nReview practical\, real-world case studies and scenarios along with current monitoring trends seen through the GCP E6(R3) lens\n\nSpeaker: Laura Adkins\, MAP CCRP\, CCRA\, AdvCRS
URL:https://socra.org/event/central-virginia-event-monitoring-oversight-with-impact/
LOCATION:Virtual 
CATEGORIES:Chapter Event
ORGANIZER;CN="Shirley Helm":MAILTO:shirley.helm@vcuhealth.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260820T100000
DTEND;TZID=America/New_York:20260820T110000
DTSTAMP:20261028T190521
CREATED:20260814T184534Z
LAST-MODIFIED:20260814T213249Z
UID:1817-1787220000-1787223600@socra.org
SUMMARY:Arkansas Chapter: Dr. Albert Kligman and the Holmesburg Prison Experiments
DESCRIPTION:Learning Objectives \n\nLearn the history behind Dr. Kligman’s experiments.\nDiscuss factors to be considered when conducting research with prisoners.\nExplore misconceptions / miscommunications surrounding informed consent.\nGain a better understanding of how to perform ethical research.\n\nSpeaker: Brandy M. Fox\, PhD
URL:https://socra.org/event/arkansas-chapter-dr-albert-kligman-and-the-holmesburg-prison-experiments/
LOCATION:Virtual 
CATEGORIES:Chapter Event
ORGANIZER;CN="Laura Adkins":MAILTO:lladkins@uams.edu
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260923
DTEND;VALUE=DATE:20260924
DTSTAMP:20261028T190521
CREATED:20260331T235044Z
LAST-MODIFIED:20260903T020829Z
UID:225-1790121600-1790207999@socra.org
SUMMARY:SOCRA Digital Health & Clinical Research Workshop
DESCRIPTION:SOCRA Digital Health & Clinical Research Workshop- LIVE\n Includes a Live In-Person Event on 09/23/2026 at 10:00 AM (EDT) \n\n\n\nAlready registered? Log in now.\n\n\n\n\n\n\nOverview\nContents (3)\n\n\n\nGoal: To equip clinical research professionals with the knowledge and practical decision-making skills to responsibly integrate digital health technologies and AI throughout the clinical trial lifecycle while ensuring participant protection\, regulatory compliance\, operational excellence\, and scientific integrity. \nMember Rate: $295.00 \nNon-Member Rate: $370.00 \nPlease book your room here: SOCRA 2026 Annual Conference – Start your reservation \nObjective: To provide participants with a practical framework for evaluating\, implementing\, and governing digital health technologies and AI across the clinical trial lifecycle\, enabling them to make informed decisions that enhance research quality\, operational efficiency\, participant experience\, and regulatory compliance. Please contact us with any questions or concerns at education@socra.org. \nLearning Objectives: Upon completion of the workshop\, the attendee should be able to: \n\nEvaluate opportunities to integrate digital health technologies (DHTs)\, artificial intelligence (AI)\, digital biomarkers\, and real-world evidence across the clinical trial lifecycle to improve research quality\, operational efficiency\, and participant experience.\nDevelop practical strategies for designing and operationalizing decentralized and hybrid clinical trials using digital informed consent\, remote participant monitoring\, and participant-centered technologies.\nApply the SMART Framework to evaluate\, implement\, and govern digital innovation throughout the clinical trial lifecycle while balancing operational efficiency\, participant protection\, regulatory compliance\, and scientific integrity.\nApply regulatory\, ethical\, equity\, and governance principles to evaluate digital health and AI solutions\, including regulatory compliance\, bias mitigation\, participant protection\, human oversight\, and responsible implementation.\nDevelop practical approaches to digital data management and governance that support data quality\, privacy\, cybersecurity\, interoperability\, and research integrity throughout the clinical trial lifecycle.\n\nPlease contact us with any questions or concerns at education@socra.org.
URL:https://socra.org/event/socra-digital-health-clinical-research-workshop/
LOCATION:Denver\, CO
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260923
DTEND;VALUE=DATE:20260924
DTSTAMP:20261028T190521
CREATED:20260331T235107Z
LAST-MODIFIED:20260331T235428Z
UID:226-1790121600-1790207999@socra.org
SUMMARY:CCRP Prep and GCP Review Course 
DESCRIPTION:
URL:https://socra.org/event/ccrp-prep-and-gcp-review-course-4/
LOCATION:Denver\, CO
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260924
DTEND;VALUE=DATE:20260925
DTSTAMP:20261028T190521
CREATED:20260331T235130Z
LAST-MODIFIED:20260331T235443Z
UID:227-1790208000-1790294399@socra.org
SUMMARY:2026 SOCRA Annual Conference
DESCRIPTION:Join over 1\,000 of your colleagues at SOCRA’s Annual Conference! Each year\, SOCRA gathers clinical research professionals from around the world. Immerse yourself in this three-day conference filled with current information\, essential tools\, best practices\, and comprehensive training to ensure your clinical research practice remains up-to-date and compliant. The program boasts expert-led academic sessions\, interactive workshops\, ample networking opportunities\, a peer-driven poster session\, and an engaging exhibit program. Don’t miss this chance to connect\, learn\, and stay at the forefront of the industry. Mark your calendar and join us!
URL:https://socra.org/event/2026-socra-annual-conference/
LOCATION:Denver\, CO
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20261028
DTEND;VALUE=DATE:20261029
DTSTAMP:20261028T190521
CREATED:20260331T235208Z
LAST-MODIFIED:20261028T182555Z
UID:228-1793145600-1793231999@socra.org
SUMMARY:CCRP Prep and GCP Review Course 
DESCRIPTION:SOCRA Education · Live Virtual Course \nCCRP Certification Preparation and GCP Virtual Review Course\n\nDatesWednesday\, December 2 – Thursday\, December 3\, 2026\nTimeBegins 12:00 PM ET\nFormatLive Virtual\n\nRegister on SOCRA Elevate →\n\n \n\n\nMember Rate \n$295.00 \n\n\nNon-Member Rate \n$370.00 \n\n\n\n\nGoal\nThe purpose of this workshop is to assist the participant in preparing for the CCRP certification examination. \nThis 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. \n\n\nObjective\nThe 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. \n\n\n \n\nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \n\nDiscuss the basic requirements necessary to meet the demands of a CRP in clinical practice\nDiscuss the basic components of compliance – Law\, regulation\, guidance\, policy and procedure\nExplain the drug/biologic development process\nDescribe the device development process\nOutline concepts for Good Clinical Practice (GCP)\nExplain the elements of informed consent\nDescribe the membership and reporting requirements of IRBs\nExplain rules relating to financial disclosure\nDiscuss the basics of study design\nExplain the rules and reporting requirements for adverse events and serious adverse events\nExplain study closure procedures and record retention guidelines\nOutline the reasons for monitoring\, audits and site visits\nExplain the Food and Drug Administration rules\, regulations\, and guidelines on research\nDiscuss the importance of investigational drug accountability\nDemonstrate and describe how to read clinical reports and records\nDiscuss Quality Assurance including\, Monitoring and Auditing\nExplain issues that would constitute clinical fraud\n\n\n\nThe 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. \n\n \n\nMeet the Faculty\n\n\n \nLaura Holtz\, MS\, CCRP\nSenior Research Manager \nLaura Holtz is a Senior Quality Specialist at the Yale Cancer Center Clinical Trials Office and a past SOCRA President. She established SOCRA’s Indianapolis chapter and co-facilitates SOCRA’s CCRP and GCP Exam Prep course. \n\nRead full bio\nLaura 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 past 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. \n\n\n\n \nKatrina A. Croghan\, MS\, CCRP\nProgram Director of Applied Clinical Research ProgramSt. Cloud State University \nKatrina Croghan is Program Director of the Applied Clinical Research Program at St. Cloud State University and Quality Management Coordinator at the Mayo Clinic Comprehensive Cancer Center. A CCRP since 2014\, she co-chairs the SOCRA Southeast MN Chapter and serves on the SOCRA Board of Directors for the 2025–2028 term. \n\nRead full bio\nKatrina 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. \nMs. 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. \nIn 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. \n\n\n\n \nJessica Rowe\, MA\, MS\, CCRP\, CIP\nQuality and Education DirectorYale Cancer Center Clinical Trials Office \nJessica Rowe is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office and the Immediate Past President of SOCRA. A CCRP and certified IRB Professional\, she teaches research compliance at the University of Maryland\, Baltimore and is faculty for several SOCRA workshops. \n\nRead full bio\nJessica 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. \nJessica 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. \nJessica 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. \nWith 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. \n\n\n\n\n \n\n\nReady to Register?\nSecure your seat through SOCRA Elevate\, SOCRA’s online learning platform. \n\nRegister Now →\n\nQuestions? Contact SOCRA at education@socra.org or 423.424.2814.
URL:https://socra.org/event/ccrp-prep-and-gcp-review-course-5/
LOCATION:Virtual 
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20261112
DTEND;VALUE=DATE:20261113
DTSTAMP:20261028T190521
CREATED:20260331T235232Z
LAST-MODIFIED:20261028T182840Z
UID:229-1794441600-1794527999@socra.org
SUMMARY:Project/Program Management
DESCRIPTION:SOCRA Education · Live In-Person Workshop \nProject/Program Management Live Workshop\n\nDatesThursday\, November 12 – Friday\, November 13\, 2026\nTimeBegins 9:30 AM ET\nLocationNashville\, TN\n\nRegister on SOCRA Elevate →\n\n \n\n\nMember Rate \n$645.00 \n\n\nNon-Member Rate \n$695.00 \n\n\n\n\nGoal\nTo equip clinical research professionals with practical project and program management tools and strategies to effectively plan\, execute\, monitor\, and lead research projects while managing risk\, finances\, contracts\, teams\, and stakeholder relationships. \n\n\nObjective\nProvide attendees with the knowledge\, tools\, and practical techniques to apply project management principles to clinical research\, including planning and tracking projects\, mitigating risk\, managing budgets and contracts\, and navigating team and organizational dynamics. \n\n\n \n\nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \n\nApply core project management principles and PMI concepts to the planning\, execution\, monitoring\, and completion of clinical research projects.\nUtilize project management tools and techniques\, including Gantt charts\, SOPs\, flowcharts\, and shared calendars\, to effectively plan\, track\, and assess project progress.\nIdentify and mitigate project risks using practical risk management and risk-avoidance strategies.\nApply effective approaches to study budgeting\, financial tracking\, contract management\, and sponsor-site negotiations throughout the clinical trial lifecycle.\nImplement strategies for managing diverse leadership and organizational styles\, resolving conflict\, strengthening teams\, and improving stakeholder collaboration.\n\n\n \n\nMeet the Faculty\n\n\n \nNancy Wintering\, MSW\, LCSW\, CCRP\nAssistant Director of ResearchMarcus Institute of Integrative Health at Thomas Jefferson University \nNancy Wintering is Assistant Director of Research at Thomas Jefferson University’s Marcus Institute of Integrative Health\, with over 30 years of experience overseeing Phase I–III studies. A CCRP since 2007 and recipient of the 2022 SOCRA President’s Special Recognition Award\, she has coauthored more than 75 peer-reviewed articles. \n\nRead full bio\nNancy 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. \n\n\n\n \nRadhika Sivaramakrishna\, PhD\, PMP\, CSSBB\, CCRP\nConsultantBiotech Companies \nRadhika Sivaramakrishna has more than 30 years of project management and clinical operations experience across academic sites\, sponsors\, CROs\, and vendors. A PMP\, ASQ-certified black belt\, and CCRP\, she consults with biotech companies and has served on the SOCRA board. \n\nRead full bio\nRadhika 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. \nPrior 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. \nDr. 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. \n\n\n\n \nDaniel Redline\, BA\, CCRP\nSenior Director of Clinical OperationsCalyxo\, Inc. \nDan Redline is Senior Director of Clinical Operations at Calyxo\, Inc.\, with over 34 years of clinical\, regulatory\, and research experience. A past SOCRA President and a CCRP for more than 22 years\, he received the SOCRA President’s Award in 2024. \n\nRead full bio\nDan has over 34 years of combined clinical\, regulatory\, and research experience in the hospital\, academic medical center\, and industry settings\, with over 20 years as a research compliance consultant. He is currently the Senior Director of Clinical Operations for Calyxo\, Inc.\, a medical device company\, an Instructor for the Clinical Research Conduct and Management Program at UC Berkeley Extension\, and an invited Lecturer and Mentor for the Robinson Life Science\, Business\, and Entrepreneurship Program at UC Berkeley. He was previously the Senior Director of Global Clinical Affairs for Align Technology\, the Senior Director of Clinical Affairs for NeuroVision\, a Senior Clinical Program Manager for Gilead Sciences\, the Director of the IRB Administration at UC Davis\, and the Director of Clinical Affairs for Volcano Corporation (now Philips); and he has held other leadership positions in industry and academia. \nDan is a past Board Member and President of SOCRA\, and previous Chair of SOCRA’s Northern California Chapter. He has been a Certified Clinical Research Professional (CCRP) for over 22 years\, and was honored to receive the SOCRA President’s Award in 2024 for his contributions to clinical research excellence. Dan has a BA in Molecular and Cell Biology\, with an emphasis in Neurobiology\, from UC Berkeley; and he completed graduate course work in the areas of Public Health and Medicine. \n\n\n\n \nLisa Benson\, BS\, CRCP\nPediatric Research Consultant \nLisa Benson is a Pediatric Research Consultant with more than 40 years in pediatric research\, and was formerly Senior Vice President of Clinical Site Network at the Institute for Advanced Clinical Trials for Children. A former SOCRA board member\, she is a well-known educator in pediatric clinical research operations. \n\nRead full bio\nLisa Benson is a Pediatric Research Consultant and formerly the Sr. Vice President of Clinical Site Network at the Institute for Advanced Clinical Trials for Children. Her pediatric research background is extensive with over 40 years in the field. She has experience in external infrastructure development and working to establish best practices and common tools for pediatric clinical trials. She has led educational programs and works with sites to ensure engagement of patients\, parents\, and children of all ages. \nFormerly she comes from the Department of Research at Connecticut Children’s Medical Center\, Hartford\, CT where she was Senior Director of Research Operations and Sponsored Program\, including the Clinical Trials Unit\, Research Compliance\, Research Finance\, Contracts\, and Grants. She has extensive experience in site management\, quality\, compliance and inter-institutional collaborations. Ms. Benson is regarded as a highly-respected research administrator and clinical research operations expert. She is a Certified Clinical Research Contract Professional and has served as board member of the Society of Clinical Research Associates (SOCRA). She has held leadership roles for the Clinical Research Associates of the Children’s Oncology Group. Ms. Benson is a well-known educator and author in pediatric clinical research operations and administration\, serving on the faculty of SOCRA\, as an invited speaker. \n\n\n\n\n \n\nHotel Accommodations\n\nBook your room in the SOCRA block for the 2026 SOCRA Project Management & Monitoring/GCP Conferences. \nBook Your Hotel Room →\n\n\n \n\n\nReady to Register?\nSecure your seat through SOCRA Elevate\, SOCRA’s online learning platform. \n\nRegister Now →\n\nQuestions? Contact SOCRA at education@socra.org or 423.424.2814.
URL:https://socra.org/event/project-program-management-advanced/
LOCATION:Nashville\, TN
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20261112
DTEND;VALUE=DATE:20261113
DTSTAMP:20261028T190521
CREATED:20260331T235256Z
LAST-MODIFIED:20261028T182945Z
UID:230-1794441600-1794527999@socra.org
SUMMARY:Monitoring & GCP Compliance Workshop
DESCRIPTION:SOCRA Education · Live In-Person Workshop \nMonitoring & GCP Compliance Live Workshop\n\nDatesThursday\, November 12 – Friday\, November 13\, 2026\nTime8:15 AM – 12:15 PM ET\nLocationNashville\, TN\n\nRegister on SOCRA Elevate →\n\n \n\n\nMember Rate \n$645.00 \n\n\nNon-Member Rate \n$695.00 \n\n\n\n\nGoal\nTo equip clinical research professionals with the knowledge and practical skills needed to effectively conduct and support clinical trial monitoring activities in accordance with Good Clinical Practice (GCP) and regulatory requirements\, ensuring participant safety\, data integrity\, protocol compliance\, and inspection readiness. \n\n\nObjective\nTo provide participants with a comprehensive understanding of clinical trial monitoring\, including regulatory requirements\, Good Clinical Practice (GCP) principles\, risk-based monitoring strategies\, and best practices for identifying and managing compliance issues to support high-quality\, inspection-ready clinical research. \n\n\n \n\nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \n\nUnderstand the purpose of clinical trial monitoring and the regulatory requirements\nApply Good Clinical Practice principles during monitoring activities and monitor prep\nEvaluate participant safety and data integrity through monitoring practices\nDescribe risk-based monitoring approaches\nIdentify\, document\, and manage non-compliance findings\nUtilize monitoring as a key component of inspection readiness and overall quality management\n\n\n \n\nMeet the Faculty\n\n\n \nEmily Scheese\nClinical Research Associate \nEmily Scheese is a Clinical Research Associate with experience in Phase I–III solid tumor oncology and neurology trials. She mentors new CRAs and serves as a data quality subject matter expert. \n\nRead full bio\nEmily Scheese is a Clinical Research Associate (CRA) with experience in Phase I–III solid tumor oncology trials and neurology research. She previously served as an early phase clinical research coordinator specializing in early phase\, solid tumor oncology. Her experience in both site and monitoring roles informs her approach to participant protection\, protocol compliance\, and site collaboration. In addition to her CRA responsibilities\, Emily serves as a mentor to new CRAs and a data quality subject matter expert\, helping colleagues strengthen data integrity and inspection readiness. She is passionate about improving patient safety through building strong site-sponsor relationships\, process improvement\, and practical education for clinical researchers. \n\n\n\n \nArianna Carrizo-Korley\, MHA\, CCRP\nRegulatory Leader \nArianna Carrizo-Korley is a regulatory leader with more than six years of experience in clinical research\, regulatory operations\, and quality management. She leads regulatory teams\, conducts internal audits\, and supports inspection readiness. \n\nRead full bio\nArianna Carrizo-Korley\, MHA\, CCRP\, is a regulatory leader with over six years of experience in clinical research\, regulatory operations\, and quality management. In addition to her master’s degree and certification of clinical research professional\, Arianna is currently undergoing her doctoral studies in Healthcare Administration. Thus\, she brings a unique combination of clinical research expertise\, regulatory knowledge\, and healthcare leadership to advancing compliant and efficient research operations. Arianna is experienced in leading regulatory teams\, strengthening IRB and sponsor compliance\, and developing standard operating procedures and training programs. Her efforts are also focused on conducting internal audits\, supporting inspection readiness\, and implementing process improvements aligned with FDA\, NCI\, sponsor\, and institutional requirements. Known for a coaching-focused leadership style\, Arianna is passionate about shaping research professionals\, improving operational workflows\, and building sustainable quality systems. Her approach emphasizes practical solutions\, transparent communication\, and scalable processes that promote both regulatory compliance and high-performing clinical research teams. \n\n\n\n \nJennifer Kinsey\, CCRP\nOncology Clinical Operations Program Manager \nJennifer Kinsey\, CCRP\, is an Oncology Clinical Operations Program Manager who has overseen the operational management of more than 150 Phase I–III clinical trials. She is dedicated to advancing cancer research through high-quality operations and regulatory compliance. \n\nRead full bio\nJennifer Kinsey\, CCRP\, is an Oncology Clinical Operations Program Manager with five years of experience in oncology clinical research. Throughout her career\, she has overseen the operational management of more than 150 Phase I-III clinical trials\, supporting the successful execution of complex research studies. Jennifer earned her Bachelors in Exercise and Sport Science from the University of North Carolina at Chapel Hill and has been a Certified Clinical Research Professional for the past two and a half years. She is dedicated to advancing cancer research through high-quality clinical trial operations\, regulatory compliance\, and fostering a patient centered research environment. \n\n\n\n\n \n\nHotel Accommodations\n\nBook your room in the SOCRA block for the 2026 SOCRA Project Management & Monitoring/GCP Conferences. \nBook Your Hotel Room →\n\n\n \n\n\nReady to Register?\nSecure your seat through SOCRA Elevate\, SOCRA’s online learning platform. \n\nRegister Now →\n\nQuestions? Contact SOCRA at education@socra.org or 423.424.2814.
URL:https://socra.org/event/monitoring-gcp-workshop-advanced/
LOCATION:Nashville\, TN
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20261117
DTEND;VALUE=DATE:20261118
DTSTAMP:20261028T190521
CREATED:20260903T021748Z
LAST-MODIFIED:20261028T183034Z
UID:2198-1794873600-1794959999@socra.org
SUMMARY:FDA Clinical Trial Requirements Regulations\, Compliance and GCP Conference
DESCRIPTION:SOCRA Education · Live In-Person Conference \nFDA Clinical Trial Requirements\, Regulations\, Compliance and GCP Live Conference\n\nDatesTuesday\, November 17 – Wednesday\, November 18\, 2026\nTime8:30 AM – 4:00 PM ET\nLocationAtlanta\, GA\n\nRegister on SOCRA Elevate →\n\n \n\n\nMember Rate \n$645.00 \n\n\nNon-Member Rate \n$695.00 \n\n\n\nAbout the Conference\nThis LIVE symposium offers a unique opportunity for sponsors\, investigators\, IRB professionals\, site personnel\, and other research stakeholders to learn directly from FDA representatives and industry experts. Through focused discussions on FDA regulations\, guidance\, compliance expectations\, and best practices\, attendees will gain practical insights applicable across the clinical research enterprise. Professionals across the clinical research enterprise will leave with actionable tools and strategies to enhance compliance\, support participant protections\, and promote high-quality research. \n\n \n\nContinuing Education Credit\n\nSOCRA 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. \nAccreditation Statements\nCME 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. \nCNE 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. \nSOCRA Course Series: 700 \n\n\n \n\nMeet the Faculty\n\n\n \nCDR Nicole Bell\nBranch ChiefFDA \nCDR Nicole Bell is a Branch Chief in FDA’s Office of Bioresearch Monitoring Inspectorate\, overseeing more than 750 domestic inspections each year. She joined FDA in 2009 as an investigator and later served as a compliance officer in the Center for Devices and Radiological Health. \n\nRead full bio\nCDR Nicole Bell’s career at the FDA began in 2009 in the Office of Regulatory Affairs (now Office of Inspections and Investigations) as an investigator performing foreign and domestic inspections of firms conducting clinical and non-clinical research trials. She spent two years as a compliance officer in the Center for Devices and Radiological Health monitoring inspection assignments and initiating administrative actions in cases of significant departure from regulations governing the protection of human subjects and investigational device exemptions. She returned to the field in 2019 and is currently a Branch Chief in the Office of Bioresearch Monitoring Inspectorate (OBMI) managing a highly experienced cadre of national and program experts\, liaising with FDA product centers in support of agency-wide bioresearch monitoring operations and overseeing the issuance of over 750 domestic inspections performed annually. CDR Bell holds a Bachelor of Science in Biochemistry from Xavier University of Louisiana\, a Master of Science in Analytical Chemistry from Louisiana State University and is currently pursuing a Doctor of Public Health from the University of South Florida. \n\n\n\n \nChristine Smith\nDivision DirectorFDA \nChristine Smith is Division Director for Division 2 in FDA’s Office of Bioresearch Monitoring Inspectorate\, leading the team that inspects clinical and non-clinical trials. She joined FDA in 1992. \n\nRead full bio\nChristine serves as the Division Director for Division 2 in the Office of Bioresearch Monitoring Inspectorate within FDA’s Office of Inspections and Investigations. She leads a team of professional investigators\, branch chiefs\, and support staff who collaborate with FDA’s product centers to conduct inspections of clinical and non-clinical trials\, post-market adverse drug experiences\, and risk evaluation and mitigation strategies. \nMs. Smith joined FDA in 1992 and holds a Bachelor of Science in Biochemistry and Molecular Biology from UMBC in Baltimore\, MD. Her career began as a student trainee physical science technician in the former Baltimore District Laboratory. Throughout her tenure\, she has held diverse roles including chemist\, investigator\, bioresearch monitoring specialist\, training officer\, supervisor\, special assistant to the deputy associate commissioner for regulatory affairs\, and director of investigations. She is passionate about continuous improvement and collaboration to promote efficiencies and best practices. \n\n\n\n \nVanessa Coulter\nProgram ExpertFDA \nVanessa Coulter is a Program Expert in FDA’s Office of Bioresearch Monitoring Inspectorate with more than 15 years of bioresearch monitoring experience. As an FDA investigator\, she conducted more than 300 inspections worldwide. \n\nRead full bio\nVanessa Coulter is a Program Expert within the Office of Bioresearch Monitoring Inspectorate at the Food and Drug Administration (FDA)\, with more than 15 years of experience in bioresearch monitoring\, clinical research compliance\, and inspectional oversight. In her current role\, she supports inspection activities and contributes to an array of cross-functional workgroups focused on training\, inspection development\, and compliance strategy. Prior to her current position\, she served as an FDA investigator for over a decade\, conducting more than 300 inspections worldwide. She holds a B.S. in Food Science from Clemson University. \n\n\n\n \nMatthew Coleman\nInvestigatorFDA \nMatthew Coleman is an Investigator with FDA’s Office of Bioresearch Monitoring Inspectorate\, with over a decade of experience conducting domestic and international inspections focused on data integrity and human subject protection. \n\nRead full bio\nMatthew R. Coleman is an Investigator with the Office of Bioresearch Monitoring Inspectorate (OBMI) at the U.S. Food and Drug Administration (FDA)\, bringing over a decade of regulatory compliance experience conducting domestic and international inspections focused on data integrity\, human subject protection\, and federal regulatory compliance — including Clinical Investigator (CI)\, Institutional Review Board (IRB)\, Postmarketing Adverse Drug Experience (PADE)\, and Risk Evaluation and Mitigation Strategy (REMS) inspections. Before joining the FDA\, he spent 11 years in Environmental Health conducting regulatory inspections across food and public health settings. He holds a Bachelor of Science in Biology and is committed to strengthening communication between regulatory authorities and clinical research professionals to promote Good Clinical Practice (GCP)\, research integrity\, and the protection of study participants. \n\n\n\n \nAnthony Grace\nInvestigatorFDA \nAnthony Grace has been an Investigator with FDA’s Office of Bioresearch Monitoring Inspectorate since 2021\, conducting inspections domestically and internationally. He previously served 12 years in the U.S. Army. \n\nRead full bio\nAnthony Grace is an Investigator with the Office of Bioresearch Monitoring Inspectorate at the U.S. Food and Drug Administration. He has been with the FDA since 2021\, conducting dozens of OBMI inspections both domestically and internationally. Prior to his role as an Investigator\, he was a Medical Technologist for other Federal Agencies and served in the U.S. Army for 12 years. Anthony holds a Bachelor’s degree in clinical laboratory science and a Master’s in Healthcare Administration. When not conducting inspections\, he enjoys spending time with his family\, watching his favorite sports teams\, and listening to music. \n\n\n\n \nAlyssa Gateman\, MPH\, CCRP\nExecutive DirectorYale Cancer Center Clinical Trials Office \nAlyssa Gateman is Executive Director of the Yale Cancer Center Clinical Trials Office and previously directed the Quality Assurance Office for Clinical Trials at Dana-Farber/Harvard Cancer Center. A former SOCRA Board member\, she is the inaugural President of the Connecticut SOCRA Chapter. \n\nRead full bio\nAlyssa 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. \nMs. 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. \nOutside 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. \n\n\n\n \nJessica Rowe\, MA\, MS\, CCRP\, CIP\nQuality and Education DirectorYale Cancer Center Clinical Trials Office \nJessica Rowe is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office and the Immediate Past President of SOCRA. A CCRP and certified IRB Professional\, she teaches research compliance at the University of Maryland\, Baltimore and is faculty for several SOCRA workshops. \n\nRead full bio\nJessica 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. \nJessica 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. \nJessica 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. \nWith 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. \n\n\n\n\n \n\nHotel Accommodations\n\nReserve your room at the SOCRA FDA Live Workshop room rate (Hotel Indigo\, 230 Peachtree Street NW\, Atlanta). \nBook Your Hotel Room →\n\n\n \n\n\nReady to Register?\nSecure your seat through SOCRA Elevate\, SOCRA’s online learning platform. \n\nRegister Now →\n\nQuestions? Contact SOCRA at education@socra.org or 423.424.2814.
URL:https://socra.org/event/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference-2/
LOCATION:Atlanta\, GA
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20261202
DTEND;VALUE=DATE:20261203
DTSTAMP:20261028T190521
CREATED:20260331T235318Z
LAST-MODIFIED:20261028T183149Z
UID:231-1796169600-1796255999@socra.org
SUMMARY:CCRP Prep and GCP Review Course 
DESCRIPTION:SOCRA Education · Live Virtual Course \nCCRP Certification Preparation and GCP Virtual Review Course\n\nDatesWednesday\, December 2 – Thursday\, December 3\, 2026\nTimeBegins 12:00 PM ET\nFormatLive Virtual\n\nRegister on SOCRA Elevate →\n\n \n\n\nMember Rate \n$295.00 \n\n\nNon-Member Rate \n$370.00 \n\n\n\n\nGoal\nThe purpose of this workshop is to assist the participant in preparing for the CCRP certification examination. \nThis 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. \n\n\nObjective\nThe 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. \n\n\n \n\nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \n\nDiscuss the basic requirements necessary to meet the demands of a CRP in clinical practice\nDiscuss the basic components of compliance – Law\, regulation\, guidance\, policy and procedure\nExplain the drug/biologic development process\nDescribe the device development process\nOutline concepts for Good Clinical Practice (GCP)\nExplain the elements of informed consent\nDescribe the membership and reporting requirements of IRBs\nExplain rules relating to financial disclosure\nDiscuss the basics of study design\nExplain the rules and reporting requirements for adverse events and serious adverse events\nExplain study closure procedures and record retention guidelines\nOutline the reasons for monitoring\, audits and site visits\nExplain the Food and Drug Administration rules\, regulations\, and guidelines on research\nDiscuss the importance of investigational drug accountability\nDemonstrate and describe how to read clinical reports and records\nDiscuss Quality Assurance including\, Monitoring and Auditing\nExplain issues that would constitute clinical fraud\n\n\n\nThe 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. \n\n \n\nMeet the Faculty\n\n\n \nLaura Holtz\, MS\, CCRP\nSenior Research Manager \nLaura Holtz is a Senior Quality Specialist at the Yale Cancer Center Clinical Trials Office and a past SOCRA President. She established SOCRA’s Indianapolis chapter and co-facilitates SOCRA’s CCRP and GCP Exam Prep course. \n\nRead full bio\nLaura 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 past 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. \n\n\n\n \nKatrina A. Croghan\, MS\, CCRP\nProgram Director of Applied Clinical Research ProgramSt. Cloud State University \nKatrina Croghan is Program Director of the Applied Clinical Research Program at St. Cloud State University and Quality Management Coordinator at the Mayo Clinic Comprehensive Cancer Center. A CCRP since 2014\, she co-chairs the SOCRA Southeast MN Chapter and serves on the SOCRA Board of Directors for the 2025–2028 term. \n\nRead full bio\nKatrina 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. \nMs. 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. \nIn 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. \n\n\n\n \nJessica Rowe\, MA\, MS\, CCRP\, CIP\nQuality and Education DirectorYale Cancer Center Clinical Trials Office \nJessica Rowe is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office and the Immediate Past President of SOCRA. A CCRP and certified IRB Professional\, she teaches research compliance at the University of Maryland\, Baltimore and is faculty for several SOCRA workshops. \n\nRead full bio\nJessica 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. \nJessica 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. \nJessica 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. \nWith 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. \n\n\n\n\n \n\n\nReady to Register?\nSecure your seat through SOCRA Elevate\, SOCRA’s online learning platform. \n\nRegister Now →\n\nQuestions? Contact SOCRA at education@socra.org or 423.424.2814.
URL:https://socra.org/event/ccrp-prep-and-gcp-review-course-6/
LOCATION:Virtual 
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DTSTART;TZID=America/New_York:20261209T083000
DTEND;TZID=America/New_York:20261209T123000
DTSTAMP:20261028T190521
CREATED:20261013T164905Z
LAST-MODIFIED:20261028T183226Z
UID:3203-1796805000-1796819400@socra.org
SUMMARY:SOCRA Oncology Virtual Workshop
DESCRIPTION:SOCRA Education · Live Virtual Workshop \nSOCRA Oncology Virtual Workshop\n\nDateWednesday\, December 9\, 2026\nTime8:30 AM ET\nFormatLive Web Event\n\nRegister on SOCRA Elevate →\n\n\n \n\n\nMember Rate \n$295.00 \n\n\nNon-Member Rate \n$370.00 \n\n\n \n\n\nGoal\nThe goal of the SOCRA Oncology Virtual Workshop is to enhance clinical research professionals’ knowledge\, confidence\, and practical skills in managing oncology clinical trials. Through interactive case studies and real-world scenarios\, participants will strengthen their ability to navigate patient enrollment\, safety reporting\, informed consent\, and regulatory compliance while promoting patient safety\, data integrity\, and high-quality clinical research. \n\n\nObjective\nTo equip clinical research professionals with the knowledge and practical skills necessary to effectively manage oncology clinical trials\, navigate complex clinical and regulatory challenges\, and ensure patient safety\, regulatory compliance\, and data integrity throughout the clinical research process. \n\n\n \n\nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \n\nDescribe the integration of clinical trials into routine oncology care and identify strategies to improve patient eligibility\, access\, and enrollment.\nApply appropriate adverse event (AE) and serious adverse event (SAE) reporting procedures\, including CTCAE grading\, attribution\, and regulatory reporting requirements.\nEvaluate complex oncology patient scenarios to determine appropriate safety assessments\, documentation\, and reporting actions.\nIdentify best practices for informed consent\, protocol deviation management\, and maintaining data integrity in oncology clinical trials.\nDevelop practical\, patient-centered strategies to strengthen regulatory compliance\, patient safety\, and the overall quality of oncology clinical research.\n\n\n \n\n\nReady to Register?\nSecure your seat through SOCRA Elevate\, SOCRA’s online learning platform. \n\nRegister Now →\n\nQuestions? Contact SOCRA at education@socra.org or 423.424.2814.
URL:https://socra.org/event/socra-oncology-virtual-workshop/
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DTSTART;TZID=UTC:20261214T080000
DTEND;TZID=UTC:20261215T120000
DTSTAMP:20261028T190521
CREATED:20261028T184111Z
LAST-MODIFIED:20261028T184111Z
UID:3450-1797235200-1797336000@socra.org
SUMMARY:SOCRA Device & Regulatory Information Workshop
DESCRIPTION:SOCRA Education · Live Virtual Workshop \nSOCRA Device & Regulatory Information Workshop\n\nStartsMonday\, December 14\, 2026\nTimeBegins 8:00 AM ET\nFormatMultiple Live Web Events\n\nRegister on SOCRA Elevate →\n\n \n\n\nMember Rate \n$295.00 \n\n\nNon-Member Rate \n$370.00 \n\n\n\n\nGoal\nThe goal of this workshop is to equip clinical research professionals with the knowledge and practical skills needed to effectively conduct and manage medical device clinical studies. Participants will gain a stronger understanding of FDA regulatory requirements\, operational best practices\, compliance responsibilities\, and financial considerations to ensure patient safety\, regulatory compliance\, and the successful execution of medical device research. \n\n\nObjective\nBy the end of this workshop\, participants will be able to identify key FDA regulatory requirements and pathways for medical device research\, understand sponsor and investigator responsibilities\, and apply Good Clinical Practice (GCP) principles. Attendees will also be able to demonstrate an understanding of device accountability\, documentation\, Medicare coverage\, research billing\, and risk management to support regulatory compliance\, patient safety\, and the effective conduct of medical device clinical studies. \n\n\n \n\nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \n\nUnderstand FDA Regulatory Requirements\nRecognize Roles and Responsibilities\nApply Good Clinical Practice (GCP) Principles\nManage Device Operations and Documentation\nUnderstand Medicare Coverage and Research Billing\nIdentify and Mitigate Compliance Risks\nApply Knowledge to Real-World Scenarios\n\n\n \n\n\nReady to Register?\nSecure your seat through SOCRA Elevate\, SOCRA’s online learning platform. \n\nRegister Now →\n\nQuestions? Contact SOCRA at education@socra.org or 423.424.2814.
URL:https://socra.org/event/socra-device-regulatory-information-workshop/
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