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Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 06/17/2026 at 12:00 PM (EDT)
This interactive virtual workshop will be facilitated by clinical research professionals with a combined industry experience of more than 20 years. The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination through a GCP review. This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice, including the ICH Guidelines and FDA Regulations that govern clinical research practice.
Goal: The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination.
This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice including the ICH Guidelines and FDA Regulations that govern clinical research practice.
Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Please contact us with any questions or concerns at education@socra.org.
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
- Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
- Explain the drug/biologic development process
- Describe the device development process
- Outline concepts for Good Clinical Practice (GCP)
- Explain the elements of informed consent
- Describe the membership and reporting requirements of IRBs
- Explain rules relating to financial disclosure
- Discuss the basics of study design
- Explain the rules and reporting requirements for adverse events and serious adverse events
- Explain study closure procedures and record retention guidelines
- Outline the reasons for monitoring, audits and site visits
- Explain the Food and Drug Administration rules, regulations, and guidelines on research
- Discuss the importance of investigational drug accountability
- Demonstrate and describe how to read clinical reports and records
- Discuss Quality Assurance including, Monitoring and Auditing
- Explain issues that would constitute clinical fraud
The purchase of this course is optional. It is not required to sit for or pass the CCRP certification exam. Purchasing and completing this course will not guarantee a passing score on the CCRP certification examination.
Please contact us with any questions or concerns at education@socra.org.
$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.
$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.
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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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Contains 5 Component(s), Includes Credits
You may happen to work with a colleague or a direct report who is difficult to please. They may have a special opinion and never want to compromise or they may think they are always right and everyone else is wrong. They want to do things their own way and poor you if you obey. Being snappy and arguing can be their norm, at the same time they still can perform very well. The speakers will share approaches and methods to manage difficult employees, including corrective and preventive measures, supported by real-life examples.
You may happen to work with a colleague or a direct report who is difficult to please. They may have a special opinion and never want to compromise or they may think they are always right and everyone else is wrong. They want to do things their own way and poor you if you obey. Being snappy and arguing can be their norm, at the same time they still can perform very well. The speakers will share approaches and methods to manage difficult employees, including corrective and preventive measures, supported by real-life examples.
OBJECTIVE: Discuss types of difficult employees and how to feel more comfortable working with or managing difficult members of the team.Start Date: 12/22/23
Termination Date: 12/22/26
$i++ ?>Anatoly Gorkun, MD, PhD, Chartered MCIPD
Senior Clinical Manager
PPD UK
Upon graduation from medical school, Anatoly worked as a Scientist at the Research Institute of Hematology where he defended his PhD. Later, Anatoly worked at a Clinical Research Organisation in different roles in Quality Assurance, Clinical Management, and Global Project Management. Later, Anatoly worked as a Senior Manager, Medical Organisation Training & Standards at MedImmune/Astra Zeneca in Cambridge, the United Kingdom. In January 2017 Anatoly joined PPD UK as a Senior Clinical Manager. His responsibilities include line management and development of clinical research professionals, resourcing, and clinical trial oversight. Anatoly is a Chartered Member of the Chartered Institute of Personnel and Development (CIPD) and Certified Trainer in the UK, with the CIPD Diploma in Human Resource Development.
$i++ ?>Hugh Devine, IMIS
Senior Director
PPD UK
Hugh Devine is a Senior Director, Clinical Operations, PPD UK & Ireland. He joined PPD in January 2004, based in Cambridge, United Kingdom. His previous roles were with Boehringer Mannheim, Innovex, Pharmacia, and Pfizer. Hugh is responsible for the Clinical Operations team’s deliverables in the UK and Ireland, managing a team over 200 individuals.
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Contains 3 Component(s), Includes Credits
Ms. Rugloski will provide tips and examples for creating and implementing a Project Team Member Transition/Training strategy to ensure effective and efficient project team member transitions. The session will end with an activity comprised of an interactive mind-mapping (‘brainstorming’) exercise with audience participation.
Ms. Rugloski will provide tips and examples for creating and implementing a Project Team Member Transition/Training strategy to ensure effective and efficient project team member transitions. The session will end with an activity comprised of an interactive mind-mapping (‘brainstorming’) exercise with audience participation.
OBJECTIVE: Discuss key elements for inclusion within a project team member transition/training plan.Start Date: 12/22/23
Termination Date: 12/22/26
$i++ ?>Carolyn Rugloski, MSc, CCRP
Senior Consultant, Lead Project Manager
FCI Consultants
Since 2008, she has served in senior project manager positions working for global CROs, MedImmune, UCSF ITN and Duke DCRI. She has dedicated her volunteer time over the years to the training of clinical trial professionals through SOCRA and other educational organizations. Recognized internationally as a Good Clinical Practice (GCP) Trainer and subject matter expert, Ms. Rugloski has consulted and lectured in North America, South America, Europe, and Asia. Ms. Rugloski is a past member of the SOCRA Board of Directors and continues to assist in the development and delivery of SOCRA events.
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Contains 5 Component(s), Includes Credits
A study’s protocol must be followed in order to maintain compliance. In order to demonstrate compliance, the study team should implement dynamic documentation that clearly and concisely tells a subject's story of participation in the clinical study. By prioritizing adherence to the protocol and documentation of the subject's experience, the study team will successfully demonstrate compliance and mitigate risk.
A study’s protocol must be followed in order to maintain compliance. In order to demonstrate compliance, the study team should implement dynamic documentation that clearly and concisely tells a subject's story of participation in the clinical study. By prioritizing adherence to the protocol and documentation of the subject's experience, the study team will successfully demonstrate compliance and mitigate risk.
OBJECTIVE: Discuss document creation and maintenance to support procedures described in the IRB-approved protocol.Start Date: 12/22/23
Termination Date: 12/22/26
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Amber Ashley Parker, BA, CCRP
Research QA Monitor, Office of Research Compliance
Children's Hospital of Philadelphia
Amber is currently a Research Quality Assurance Monitor in the Office of Research Compliance (ORC) at the Children’s Hospital of Philadelphia (CHOP). Amber has over a decade of experience in the business and conduct of clinical research as a public relations representative, clinical research coordinator, research associate, and investigator. Her education and professional experience allows her to successfully consult with study teams and various organizations on research initiatives. Amber is currently pursuing a Master’s of Bioethics at the Perelman School of Medicine at the University of Pennsylvania and holds a Bachelors of Arts in Health & Societies, with a concentration in Bioethics & Society from University of Pennsylvania. She also completed a University minor in Health Care Management and Biological Basis of Behavior from the Wharton School of Business and the College of Arts & Sciences at the University of Pennsylvania. Amber is a Certified Clinical Research Professional, by the Society of Clinical Research Associates (SOCRA), and is also an active member of the Regulatory Affairs Professional Society (RAPS).
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Contains 5 Component(s), Includes Credits
According to Paulo Coelho, “the secret to life is to fall down seven times and to get up eight times”. Resilience, from the Latin “to leap back”, is the process and experience of being disrupted by change, opportunities, stressors and adversity and accessing gifts and strengths to grow stronger. This session examines diverse aspects of resilience or “bounce-back ability” in the workplace including the importance, components and development of resilience. The session also includes a brief assessment of personal resilience as well as how to design a resilience development plan.
According to Paulo Coelho, “the secret to life is to fall down seven times and to get up eight times”. Resilience, from the Latin “to leap back”, is the process and experience of being disrupted by change, opportunities, stressors and adversity and accessing gifts and strengths to grow stronger. This session examines diverse aspects of resilience or “bounce-back ability” in the workplace including the importance, components and development of resilience. The session also includes a brief assessment of personal resilience as well as how to design a resilience development plan.
OBJECTIVE: Discuss diverse aspects of resilience or “bounce-back ability” in the workplace and how to design a resilience development plan.Start Date: 12/22/23
Termination Date: 12/22/26
$i++ ?>Barbara van der Schalie, MS
Senior Clinical Training Manager
Leidos Biomedical Research Inc.
Barbara has over twenty-five years of experience in education, with the last twenty-five years focused on outcomes-based adult professional training. She is currently the Clinical Training/Learning and Professional Development Manager at Leidos Biomedical Research, Inc. serving the Division of Clinical Research (DCR) of National Institute of Allergy and Infectious Disease (NIAID), in a Learning and Professional Development role, and is also responsible for the compliance, technical and professional development training for Clinical Monitoring Research Program staff of Leidos Biomedical Research, Inc. Frederick. She has a Bachelor’s of Science in Biology and Chemistry/Secondary Education and a Master’s of Science in Biomedical Sciences with a concentration in Cellular Biology. Barbara has also taught Human Anatomy and Physiology in the Allied Health Program at Frederick Community College since 1993 and is still an active instructor in this program.
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Contains 5 Component(s), Includes Credits
Identifying common oncology research queries and trends can provide added efficiency in addressing them. Understanding the rationale for these common queries can provide insight into methods by which they can be prevented. Finally, understanding how to successfully resolve queries is a critical skill for the clinical research professional.
Identifying common oncology research queries and trends can provide added efficiency in addressing them. Understanding the rationale for these common queries can provide insight into methods by which they can be prevented. Finally, understanding how to successfully resolve queries is a critical skill for the clinical research professional.
OBJECTIVE: Discuss the challenges unique to the “experienced patient” with cancer relapse who is being asked to consider enrolling in a clinical trial.Start Date: 12/22/23
Termination Date: 12/22/26
$i++ ?>Rachel Kingsford, MS, CCRP
Training and Mentorship Manager
Huntsman Cancer Institute
Rachel is the Training and Mentorship Manager for the Clinical Trials Offices at the Huntsman Cancer Institute in Salt Lake City, UT. In this role, Rachel has developed and maintains a comprehensive training program for research staff, centered on local, national, and international regulations. She currently serves as Chair for the Utah SOCRA Chapter. Rachel holds a Master's degree in sociology from Utah State University.
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Contains 5 Component(s), Includes Credits
The value of implementing preventive quality assurance measures is essential to ensuring research compliance. Significant findings during an inspection or audit can results in damaged reputations, loss of existing or future funding, and impact the confidence of the research team. For a research team to be successful, it is vital they proactively identify risks and implement measures to ensure patient safety and the integrity of the research. This proactive approach provides opportunities for coaching, mentoring, and training in a supportive non-punitive way. Preventive measures can provide confidence within the research team, preventing the crisis mode mentality that often precedes an audit or inspection.
The value of implementing preventive quality assurance measures is essential to ensuring research compliance. Significant findings during an inspection or audit can results in damaged reputations, loss of existing or future funding, and impact the confidence of the research team. For a research team to be successful, it is vital they proactively identify risks and implement measures to ensure patient safety and the integrity of the research. This proactive approach provides opportunities for coaching, mentoring, and training in a supportive non-punitive way. Preventive measures can provide confidence within the research team, preventing the crisis mode mentality that often precedes an audit or inspection.
OBJECTIVE: Understand the value of prevention and how to implement preventive measures.Start Date: 12/22/2023
Termination Date: 12/22/2026
$i++ ?>Angie Price, MSN, CCRC
Project Director, Clinical Site Network
Institute for Advanced Clinical Trials for Children (I-ACT)
Angie is the Project Director, Clinical Site Network at -ACT for Children. She is overseeing the Children’s Pediatric Improvement collaborative for Clinical Trials & Research, otherwise known as PICTR®. Mrs. Price has over 30 years’ of clinical trials experience. She has been certified in clinical research since 1999. She holds a master’s degree in clinical research administration.
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