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Contains 4 Component(s), Includes Credits Includes Multiple Live Events. The next is on 05/20/2026 at 1:00 PM (EDT)
This introduction to Clinical Research Project Management Workshop incorporates a broad range of skill sets in order to plan, administer, track, evaluate and report on activities involved clinical research process. The goal of this interactive workshop is to introduce, affirm, and enhance the participant’s understanding of project management.
Goal: This introduction to clinical research project management workshop incorporates a broad range of skill sets in order to plan, administer, track, evaluate and report on activities involved clinical research process. The goal of this interactive workshop is to introduce, affirm, and enhance the participant’s understanding of project management.
Objective: Through discussion, presentation, and interaction, this virtual program will broaden the participants’ knowledge of the project management art and science. Please contact us with any questions or concerns at education@socra.org.
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Describe skills and responsibilities to move from a clinical research coordinator or other research roles to learn about the responsibilities of a Project Manager.
- Define key terms and concepts associated with Project Management.
- Describe project management processes following PMI (Project Management Institute) guidelines (initiation, planning, execution, monitoring, controlling, and closing).
- Discuss the processes and procedures that are necessary to develop an infrastructure that will support the various tasks associated with Project Management in Clinical Research.
- Describe Project Management constraints including Scope, Time, Budget, and Performance.
- Learn about effective strategies in Virtual Project Management and Decentralized Clinical Trials.
- Discuss basic principles of Risk Management, Risk Avoidance and Risk Mitigation.
- Learn how Organizational Tools and Techniques can improve effectiveness and maintain quality in project management.
- Discuss Organizational Dynamics and self-management in project management to promote effective team building.
- Discuss approaches to work effectively with different leadership styles and organizational cultures.
Please contact us with any questions or concerns at education@socra.org.
$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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- Describe skills and responsibilities to move from a clinical research coordinator or other research roles to learn about the responsibilities of a Project Manager.
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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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