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. 

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

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

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

Jessica Rowe, MA, MS, CCRP, CIP, 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.

CDR 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.

Christine 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.

Ms. 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.

Vanessa 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.

Matthew 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.

Anthony 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.

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. 

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.

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

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

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP 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

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.

Lisa Benson, is a Pediatric Research Consultant and formerly the Sr. Vice President of Clinical Site Network at the Institute for Advance 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. Formerly 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.

Emily 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. 

Arianna 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.

Jennifer 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

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. 

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

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

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

Jessica Rowe, MA, MS, CCRP, CIP, 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.

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.

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.

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

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