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Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 12/02/2026 at 12:00 PM (EST)
This interactive virtual workshop will be facilitated by clinical research professionals with a combined industry experience of more than 20 years. The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination through a GCP review. This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice, including the ICH Guidelines and FDA Regulations that govern clinical research practice.
Goal: The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination.
This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice including the ICH Guidelines and FDA Regulations that govern clinical research practice.
Member Rate: $295.00
Non-Member Rate: $370.00
Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Please contact us with any questions or concerns at [email protected].
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
- Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
- Explain the drug/biologic development process
- Describe the device development process
- Outline concepts for Good Clinical Practice (GCP)
- Explain the elements of informed consent
- Describe the membership and reporting requirements of IRBs
- Explain rules relating to financial disclosure
- Discuss the basics of study design
- Explain the rules and reporting requirements for adverse events and serious adverse events
- Explain study closure procedures and record retention guidelines
- Outline the reasons for monitoring, audits and site visits
- Explain the Food and Drug Administration rules, regulations, and guidelines on research
- Discuss the importance of investigational drug accountability
- Demonstrate and describe how to read clinical reports and records
- Discuss Quality Assurance including, Monitoring and Auditing
- Explain issues that would constitute clinical fraud
The purchase of this course is optional. It is not required to sit for or pass the CCRP certification exam. Purchasing and completing this course will not guarantee a passing score on the CCRP certification examination.
Please contact us with any questions or concerns at [email protected].
$i++ ?>Laura Holtz, MS, CCRP (Moderator)
Senior Research Manager
Laura R. Holtz, MS, PMP, CCRP, is a Senior Quality Specialist at Yale University, Yale Cancer Center, Clinical Trials Office. Previously, she was a senior project manager at the Indiana University Center for Aging Research on federally- funded randomized control trials and demonstration programs to provide care collaboration for patients with dementia and their caregivers in multiple care settings. She also coordinated an annual statewide conference focused on palliative and end-of-life communication and research. She shares her expertise in regulations, informed consent, decision making capacity, patient/caregiver interviewing, ethics, and research project management at numerous local and national conferences. Laura established the Indianapolis chapter of Society of Clinical Research Associates (SOCRA) and organizes education opportunities which provide pathways for staff to become Certified Clinical Research Professionals. She is a co-facilitator for the SOCRA Clinical Site Coordination/ Management and Good Clinical Practice (GCP) workshop and the Certified Clinical Research Professional (CCRP) and GCP Exam Prep course. As the 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.
$i++ ?>Katrina A. Croghan, M.S., CCRP (Moderator)
Program Director of Applied Clinical Research Program
St. Cloud State University
Katrina Croghan serves as the Program Director of the Applied Clinical Research Program at St. Cloud State University (SCSU), where she leads a curriculum focused on providing comprehensive, industry-driven knowledge to prepare students for successful careers in clinical research. She also holds the position of Quality Management Coordinator (QMC) at the Mayo Clinic Comprehensive Cancer Center (MCCCC), overseeing the establishment, maintenance, and education related to all MCCCC documentation, policies, and procedures.
Ms. Croghan earned both her B.S. and M.S. degrees from SCSU and has been a Certified Clinical Research Professional (CCRP) since 2014, accredited by the Society of Clinical Research Associates (SOCRA). She joined the Applied Clinical Research Program at SCSU as adjunct faculty in 2023 and has been with Mayo Clinic since 2012. Her professional journey in clinical research began within the Department of Medicine—Clinical Research Office, later expanding to the Cancer Center in 2015. There, she held roles such as Certified Clinical Research Coordinator (CRC), Lead CRC, and Senior CRC, before advancing to her current QMC role.
In recognition of her expertise, Ms. Croghan attained the rank of Assistant Professor at SCSU in 2025 and was named Assistant Professor of Health Care Administration at Mayo Clinic in 2023. In addition to her primary responsibilities, she co-chairs the SOCRA Southeast MN Chapter and was recently appointed to the SOCRA Board of Directors for the 2025-2028 term.
$i++ ?>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.
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Register
- Member - $295
- Non-member - $370
- More Information
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Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 11/17/2026 at 8:30 AM (EST)
This LIVE 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 LIVE 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 [email protected].
Please book your Hotel Room here: SOCRA FDA LIVE WORKSHOP ROOM RATE
Dates:
Tuesday November 17th and Wednesday November 18th, 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
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 [email protected].
$i++ ?>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.
$i++ ?>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.
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Register
- Member - $645
- Non-member - $695
- More Information
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Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 11/12/2026 at 9:30 AM (EST)
Strengthen your project management skills with practical strategies for managing clinical research projects from start to finish. This two-day conference combines expert-led sessions, practical tools, and real-world examples covering project management infrastructure, PMI principles, planning and tracking, risk management, study budgeting and financial management, contract development and negotiation, and team and organizational dynamics. Attendees will leave with actionable tools and strategies to improve collaboration, manage challenges, and successfully lead clinical research projects and programs.
Goal: To 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.
Member Rate: $645.00
Non-Member Rate: $695.00
Objective: Provide 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,a nd navigating team and organizational dynamics. Please contact us with any questions or concerns at [email protected].
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Apply core project management principles and PMI concepts to the planning, execution, monitoring, and completion of clinical research projects.
- Utilize project management tools and techniques, including Gantt charts, SOPs, flowcharts, and shared calendars, to effectively plan, track, and assess project progress.
- Identify and mitigate project risks using practical risk management and risk-avoidance strategies.
- Apply effective approaches to study budgeting, financial tracking, contract management, and sponsor-site negotiations throughout the clinical trial lifecycle.
- Implement strategies for managing diverse leadership and organizational styles, resolving conflict, strengthening teams, and improving stakeholder collaboration.
Please book your Hotel Room here: 2026 SOCRA Project Management & Monitoring/GCP Conferences - Start your reservation
Please contact us with any questions or concerns at [email protected].
$i++ ?>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.
$i++ ?>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
$i++ ?>Daniel Redline, BA, CCRP (Moderator)
Senior Director of Clinical Operations
Calyxo, Inc.
Dan 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. Dan 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.
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Register
- Member - $645
- Non-member - $695
- More Information
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Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 11/12/2026 at 9:15 AM (EST)
This interactive workshop provides participants with a practical understanding of clinical trial monitoring and the application of Good Clinical Practice (GCP) principles throughout the research process. Attendees will learn the purpose and regulatory requirements of monitoring, explore risk-based monitoring approaches, and develop strategies for evaluating participant safety, data integrity, and protocol compliance. The workshop also covers identifying and managing non-compliance findings, preparing for monitoring visits, and using effective monitoring practices to support inspection readiness and strengthen overall quality management systems.
Goal: To 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.
Member Rate: $645.00
Non-Member Rate: $695.00
Objective: To 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. Please contact us with any questions or concerns at [email protected].
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Understand the purpose of clinical trial monitoring and the regulatory requirements
- Apply Good Clinical Practice principles during monitoring activities and monitor prep
- Evaluate participant safety and data integrity through monitoring practices
- Describe risk-based monitoring approaches
- Identify, document, and manage non-compliance findings
- Utilize monitoring as a key component of inspection readiness and overall quality management
Please book your Hotel Room here: 2026 SOCRA Project Management & Monitoring/GCP Conferences - Start your reservation
Please contact us with any questions or concerns at [email protected].
-
Register
- Member - $645
- Non-member - $695
- More Information
-
Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 10/28/2026 at 12:00 PM (EDT)
This interactive virtual workshop will be facilitated by clinical research professionals with a combined industry experience of more than 20 years. The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination through a GCP review. This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice, including the ICH Guidelines and FDA Regulations that govern clinical research practice.
Goal: The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination.
This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice including the ICH Guidelines and FDA Regulations that govern clinical research practice.
Member Rate: $295.00
Non-Member Rate: $370.00
Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Please contact us with any questions or concerns at [email protected].
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
- Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
- Explain the drug/biologic development process
- Describe the device development process
- Outline concepts for Good Clinical Practice (GCP)
- Explain the elements of informed consent
- Describe the membership and reporting requirements of IRBs
- Explain rules relating to financial disclosure
- Discuss the basics of study design
- Explain the rules and reporting requirements for adverse events and serious adverse events
- Explain study closure procedures and record retention guidelines
- Outline the reasons for monitoring, audits and site visits
- Explain the Food and Drug Administration rules, regulations, and guidelines on research
- Discuss the importance of investigational drug accountability
- Demonstrate and describe how to read clinical reports and records
- Discuss Quality Assurance including, Monitoring and Auditing
- Explain issues that would constitute clinical fraud
The purchase of this course is optional. It is not required to sit for or pass the CCRP certification exam. Purchasing and completing this course will not guarantee a passing score on the CCRP certification examination.
Please contact us with any questions or concerns at [email protected].
$i++ ?>Laura Holtz, MS, CCRP (Moderator)
Senior Research Manager
Laura R. Holtz, MS, PMP, CCRP, is a Senior Quality Specialist at Yale University, Yale Cancer Center, Clinical Trials Office. Previously, she was a senior project manager at the Indiana University Center for Aging Research on federally- funded randomized control trials and demonstration programs to provide care collaboration for patients with dementia and their caregivers in multiple care settings. She also coordinated an annual statewide conference focused on palliative and end-of-life communication and research. She shares her expertise in regulations, informed consent, decision making capacity, patient/caregiver interviewing, ethics, and research project management at numerous local and national conferences. Laura established the Indianapolis chapter of Society of Clinical Research Associates (SOCRA) and organizes education opportunities which provide pathways for staff to become Certified Clinical Research Professionals. She is a co-facilitator for the SOCRA Clinical Site Coordination/ Management and Good Clinical Practice (GCP) workshop and the Certified Clinical Research Professional (CCRP) and GCP Exam Prep course. As the 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.
$i++ ?>Katrina A. Croghan, M.S., CCRP (Moderator)
Program Director of Applied Clinical Research Program
St. Cloud State University
Katrina Croghan serves as the Program Director of the Applied Clinical Research Program at St. Cloud State University (SCSU), where she leads a curriculum focused on providing comprehensive, industry-driven knowledge to prepare students for successful careers in clinical research. She also holds the position of Quality Management Coordinator (QMC) at the Mayo Clinic Comprehensive Cancer Center (MCCCC), overseeing the establishment, maintenance, and education related to all MCCCC documentation, policies, and procedures.
Ms. Croghan earned both her B.S. and M.S. degrees from SCSU and has been a Certified Clinical Research Professional (CCRP) since 2014, accredited by the Society of Clinical Research Associates (SOCRA). She joined the Applied Clinical Research Program at SCSU as adjunct faculty in 2023 and has been with Mayo Clinic since 2012. Her professional journey in clinical research began within the Department of Medicine—Clinical Research Office, later expanding to the Cancer Center in 2015. There, she held roles such as Certified Clinical Research Coordinator (CRC), Lead CRC, and Senior CRC, before advancing to her current QMC role.
In recognition of her expertise, Ms. Croghan attained the rank of Assistant Professor at SCSU in 2025 and was named Assistant Professor of Health Care Administration at Mayo Clinic in 2023. In addition to her primary responsibilities, she co-chairs the SOCRA Southeast MN Chapter and was recently appointed to the SOCRA Board of Directors for the 2025-2028 term.
$i++ ?>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.
-
Register
- Member - $295
- Non-member - $370
- More Information
-
Contains 3 Component(s), Includes Credits Includes a Live In-Person Event on 09/23/2026 at 10:00 AM (EDT)
This interactive workshop explores how digital health technologies, artificial intelligence (AI), and decentralized clinical trial approaches can be effectively integrated across the clinical trial lifecycle. Using a fictional case study and the SMART Framework, participants will learn how to evaluate, implement, and govern digital innovations while maintaining regulatory compliance, participant safety, data integrity, and scientific rigor. By the end of the workshop, attendees will have practical strategies for leading digital transformation in clinical research and applying emerging technologies responsibly within their organizations.
Goal: 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.
Member Rate: $295.00
Non-Member Rate: $370.00
Please book your room here: SOCRA 2026 Annual Conference - Start your reservation
Objective: 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 [email protected].
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Evaluate 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.
- Develop practical strategies for designing and operationalizing decentralized and hybrid clinical trials using digital informed consent, remote participant monitoring, and participant-centered technologies.
- Apply 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.
- Apply 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.
- Develop practical approaches to digital data management and governance that support data quality, privacy, cybersecurity, interoperability, and research integrity throughout the clinical trial lifecycle.
Please contact us with any questions or concerns at [email protected].
-
Register
- Member - $295
- Non-member - $370
- More Information
-
Contains 3 Component(s), Includes Credits Includes a Live In-Person Event on 09/23/2026 at 10:00 AM (EDT)
This interactive live workshop will be facilitated by clinical research professionals with a combined industry experience of more than 20 years. The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination through a GCP review. This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice, including the ICH Guidelines and FDA Regulations that govern clinical research practice.
Goal: The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination.
This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice including the ICH Guidelines and FDA Regulations that govern clinical research practice.
Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Please contact us with any questions or concerns at [email protected].
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
- Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
- Explain the drug/biologic development process
- Describe the device development process
- Outline concepts for Good Clinical Practice (GCP)
- Explain the elements of informed consent
- Describe the membership and reporting requirements of IRBs
- Explain rules relating to financial disclosure
- Discuss the basics of study design
- Explain the rules and reporting requirements for adverse events and serious adverse events
- Explain study closure procedures and record retention guidelines
- Outline the reasons for monitoring, audits and site visits
- Explain the Food and Drug Administration rules, regulations, and guidelines on research
- Discuss the importance of investigational drug accountability
- Demonstrate and describe how to read clinical reports and records
- Discuss Quality Assurance including, Monitoring and Auditing
- Explain issues that would constitute clinical fraud
The purchase of this course is optional. It is not required to sit for or pass the CCRP certification exam. Purchasing and completing this course will not guarantee a passing score on the CCRP certification examination.
Please contact us with any questions or concerns at [email protected].
$i++ ?>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.
$i++ ?>Laura Holtz, MS, CCRP (Moderator)
Senior Research Manager
Laura R. Holtz, MS, PMP, CCRP, is a Senior Quality Specialist at Yale University, Yale Cancer Center, Clinical Trials Office. Previously, she was a senior project manager at the Indiana University Center for Aging Research on federally- funded randomized control trials and demonstration programs to provide care collaboration for patients with dementia and their caregivers in multiple care settings. She also coordinated an annual statewide conference focused on palliative and end-of-life communication and research. She shares her expertise in regulations, informed consent, decision making capacity, patient/caregiver interviewing, ethics, and research project management at numerous local and national conferences. Laura established the Indianapolis chapter of Society of Clinical Research Associates (SOCRA) and organizes education opportunities which provide pathways for staff to become Certified Clinical Research Professionals. She is a co-facilitator for the SOCRA Clinical Site Coordination/ Management and Good Clinical Practice (GCP) workshop and the Certified Clinical Research Professional (CCRP) and GCP Exam Prep course. As the 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.
$i++ ?>Katrina A. Croghan, M.S., CCRP (Moderator)
Program Director of Applied Clinical Research Program
St. Cloud State University
Katrina Croghan serves as the Program Director of the Applied Clinical Research Program at St. Cloud State University (SCSU), where she leads a curriculum focused on providing comprehensive, industry-driven knowledge to prepare students for successful careers in clinical research. She also holds the position of Quality Management Coordinator (QMC) at the Mayo Clinic Comprehensive Cancer Center (MCCCC), overseeing the establishment, maintenance, and education related to all MCCCC documentation, policies, and procedures.
Ms. Croghan earned both her B.S. and M.S. degrees from SCSU and has been a Certified Clinical Research Professional (CCRP) since 2014, accredited by the Society of Clinical Research Associates (SOCRA). She joined the Applied Clinical Research Program at SCSU as adjunct faculty in 2023 and has been with Mayo Clinic since 2012. Her professional journey in clinical research began within the Department of Medicine—Clinical Research Office, later expanding to the Cancer Center in 2015. There, she held roles such as Certified Clinical Research Coordinator (CRC), Lead CRC, and Senior CRC, before advancing to her current QMC role.
In recognition of her expertise, Ms. Croghan attained the rank of Assistant Professor at SCSU in 2025 and was named Assistant Professor of Health Care Administration at Mayo Clinic in 2023. In addition to her primary responsibilities, she co-chairs the SOCRA Southeast MN Chapter and was recently appointed to the SOCRA Board of Directors for the 2025-2028 term.
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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.
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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
$i++ ?>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.
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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
$i++ ?>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.
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