Catching up with 2023 SOCRA President’s Award Winner Tammy Neseth, MA, CCRP, CIP

Tammy Neseth, MA, CCRP, CIP

The global clinical research community will converge live and in-person from September 29 – October 1 at SOCRA’s 2023 Annual Conference in Montreal, QC, Canada. During the event, we will present the President’s Award to Tammy Neseth, MA, CCRP, CIP, in recognition of her exceptional service and commitment to SOCRA’s mission.  

With a foundational career at the Mayo Clinic focusing on colorectal cancer screening, Tammy has worked extensively in the clinical research regulatory and compliance sectors. Her journey includes pivotal roles, most notably as the Director of Operations for the Mayo Clinic Institutional Review Board.  A Saint Mary’s University of Minnesota graduate, Tammy has been a dedicated member of SOCRA since 2003, undertaking leadership positions including (but not limited to) co-chairing the SOCRA Oncology Conference and the SOCRA Site Coordinator / Manager Workshop, leading the SOCRA Southeast Minnesota Chapter, and serving on the SOCRA Certification Committee and Board of Directors. 

Join us as we delve into a candid conversation with Tammy about her career journey, her take on clinical research, her experience with SOCRA, and a wealth of insights and inspiration. 

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Celebrating Clinical Trials Day 2023: Let’s Raise Awareness & Honor Research Professionals

May 20th marks Clinical Trials Day (CTD), an annual day of celebration and reflection for the clinical research community. This date commemorates the day in 1747 when James Lind launched the first-ever clinical trial, laying the foundation for modern clinical research. Since 2005, CTD has been celebrated internationally to raise awareness about the importance of clinical trials and honor clinical research professionals’ contributions.  

In this article, we’ll explore why it’s important to raise awareness about clinical trials and how we can honor the invaluable work of research professionals on this special day. In addition, we’ll explain why supporting and celebrating the people who dedicate their lives to improving public health through clinical research is more important than ever. So, let’s kick off the celebration of Clinical Trials Day 2023 together! 

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A “WIN” for FDA’s ORA Women Investigators

In Interview with

Andrace De Yampert, MS

This Women’s History Month, we’d like to express our gratitude to those in the clinical research community who dedicate their careers to advancing inclusivity and equality in our field. Whether through small acts of empowerment or sweeping organizational changes, every effort helps pave the way for a brighter future for all.  

In the spirit of empowering women in clinical research, this post will introduce you to the Women’s Investigator Network (WIN) and the women behind it. This distinctive program at the Food & Drug Administration (FDA) Office of Regulatory Affairs (ORA) supports women serving as ORA investigators by providing opportunities for professional development, leadership training, and personal empowerment. With more than 300 members and growing, WIN is a shining example of how organizations can foster a culture of inclusivity and diversity within the clinical research community. 

In honor of WIN’s second anniversary, we caught up with Andrace De Yampert, FDA ORA Office of Bioresearch Monitoring Operations (OBIMO) Program Expert and WIN Vice Chair, to learn more about her, the network, and its impact on women investigators at the FDA.  

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Medicare Coverage Analysis – A Billing Compliance Perspectives

Sachit Verma, MD, MBA, FAPCR

Medicare Coverage Analysis (MCA) is a uniform methodology of analyzing the items and services provided in a clinical research study, i.e., a comprehensive review of protocol documents that helps identify the appropriate payor (sponsor or third-party) for each study service, assessment of the protocol driven items and procedures that can be billed to either insurance, as routine cost, or as costs billable to the study sponsors.

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Leadership and Line Management in Clinical Research

Anatoly Gorkun
Senior Manager, Global Clinical Management, PPD
Hugh Devine
Senior Director, Global Clinical Management, PPD

Abstract: Line management is generic, utilizing the same approaches throughout all industries; line management brings together company needs and its workforce to deliver company objectives. This article provides an overview of line management styles and line-management-through-leadership approaches in the clinical research environment. The line management cycle – team building, support, motivation, and development—is described. Real-life examples illustrate how line management can support clinical research deliverables.

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Clinical Research Nursing Conference– Understanding the role that nurses play in Clinical Research and Empowering them to become leaders in the field

Jennifer Goldfarb, MSN, RN, CCRP

We here at SOCRA are very excited for the relaunch of the Clinical Research Nursing Conference which will be offered virtually this November. The course faculty includes very experienced clinical research nursing professionals who will be bringing a wealth of knowledge and experience to the conference attendees. Take a look below for our Course Chair’s personal perspectives on Clinical Research Nursing – how she became a nurse, then clinical research professional and why she’s not only excited for this course, but also where the field is headed. As you’ll see below – this is an exciting time. This conference presents the opportunity to highlight the role that nurses play in Clinical Research, to celebrate this role, and to empower them to become leaders in the field.

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Partnering with Patients to Accelerate Cancer Research: Count Me In

Sara Balch, author

Sara Balch, BS, Project Manager, Count Me In and the Broad Institute of MIT and Harvard

Abstract: Count Me In is a research initiative whose aim is to engage patients living with all major cancer types, as well as those with rare cancers. Along with this goal, Count Me In hopes to bring about a cultural shift that empowers patients, researchers, and clinicians to work in partnership and accelerate medical progress by allowing  researchers to work directly with patients and advocacy groups along with software engineers and computational scientists, to collect, analyze, and share de-identified data. The combined power of thousands of individual experiences will assist researchers in understanding, why patients respond differently to treatments, uncover new genetic targets for therapies, and help propel groundbreaking discoveries that transform cancer care.

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Pediatric Recruitment: What Works and What Does Not Work

Waseem Muhammad Pediatric Research

Muhammad Waseem, MD, MS, CCRP, CIP, CHSE-A

Abstract: While research involving pediatric patients may be challenging, the rewards can be significant. This article describes challenges in pediatric recruitment and how enrollment in pediatric research is unique versus research involving adult patients. Highlighted are effective approaches for engaging children and their parents and techniques to improve recruitment and adherence and to help reduce dropout rates. Researchers should always put the interests and safety of the participants and their families first and comply with appropriate research guidelines and study protocol.

Disclosure: The author does not have any financial disclosures or conflicts of interest to declare.

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Operationalizing the Serious Adverse Event (SAE) Process at Clinical Research Sites

Operationalizing Serious Adverse Event Process

Tracy Popp, MBA
Previously: Director, Research Financial Operations Norton Healthcare, Inc.
Currently: Senior Director of Clinical Research, Tampa General Hospital

Abstract: It is important for clinical research sites to operationalize the serious adverse event (SAE) process beyond regulatory and clinical. Norton Healthcare, Inc. has developed policies and a workflow for operationalizing SAEs, including clinical, legal, billing, accounting, and budgeting capture. This article provides an overview of the way in which Norton Healthcare has done this as well as how other sites can also operationalize SAEs.

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Conducting Clinical Trials in Canada Inspections of Clinical Investigators

Clinical Investigator Inspections

Mike M. Rashti President, BIMO Auditor and Trainer, LLC

Abstract: This article provides an overview of the U.S. Food and Drug Administration’s (FDA’s) foreign inspection program and the Bioresearch Monitoring Program as it is applied to inspections in Canada. How to prepare for an inspection and differences between inspections of clinical research sites in the United States and Canada are discussed. Protocol violations observed at Canadian sites that have been documented by FDA Form 483s (Inspectional Findings) and Warning Letters are noted in this article.

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