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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10 Reasons to Attend the 16th Annual Device Research & Regulatory Conference

Angie Rock

MBA, CCRP

Kathi Durdon

MA, CCRP

Early in her medical device research career, Kathi Durdon, MA, CCRP, discovered a gaping hole in the professional conference offerings: most were geared toward pharmaceuticals, not devices – so she created one.

“My initial incentive for starting an annual device conference was because I needed help. I wanted to connect with subject matter experts, get new updates, and share resources. I knew it would be helpful for others, too,” said Kathi. As a member-driven organization, SOCRA enthusiastically supported Kathi’s vision, and the Annual Device Research & Regulatory Conference was born.

“Thanks to SOCRA’s support, I could create a different kind of conference – one where attendees would come every year to discuss and learn about an evolving array of topics. I also wanted a full complement of speakers who are experts in different areas – not just one or two areas,” Kathi recalled.

With Kathi at the helm, the first Device Research & Regulatory Conference was held in 2007, and sixteen years later, it’s still the medical device research “go to” conference. The conference started as a two-day program and then the faculty added a half-day Device Basics workshop thanks to past co-chair, Donna Headlee, RN, BSN, CCRP, who developed and still presents at the program today.

As we gear up for the 16th year, the Device Research & Regulatory Conference is still going strong. And as Kathi prepares to turn over the reins to Angie Rock, MBA, CCRP in 2024, the two gathered to commemorate Kathi’s tenure, to discuss the importance of the program, and to discuss future plans for the conference.

“This conference is Kathi’s brainchild. I’m honored to be a part of this phenomenal program – it is the premier conference for medical device professionals and one of the first that is entirely clinically oriented,” said Angie.

In this post, we’ll outline Kathi and Angie’s top ten reasons to attend this annual conference and why it’s important for device newbies and experts alike.

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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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Leveraging eSource as a Study Manager for Remote Monitoring 

By:  Takoda Roland, CTM, CCRA, Associate Director of Clinical Operations, Sitero

 

I have long been a proponent of the potential of eSource and its advantages in clinical trials.  From my experience as a CRA (Clinical Research Associate) I first wrote about eSource in Nov 2018 SOCRA and Jan 2019 ACRP which enabled me to see that clinical research was only just scratching the surface on leveraging eSource to fundamentally change the way we are monitoring clinical trials.  At the time I did not expect to be find myself in a position to make a meaningful shift towards remote monitoring.  Several years later while working as a CTM (Clinical Team Manager) COVID forced CROs (Contract Research Organizations) to rethink their monitoring paradigm.  Drawing from both my own and my team’s experience with eSource, our study was able to successfully implement a remote monitoring process to mitigate the issues of running a clinical trial during a pandemic.  Even as someone who had long advocated for remote monitoring using eSource, I found myself astounded at the success our team achieved.   

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SOCRA 2022 Year in Review & What to Expect in 2023

As 2022 draws to a close, we’re proud to recognize the year’s activities, accomplishments, and progress as we prepare to welcome the New Year ahead. We invite you to join us in reflecting on 2022 and looking ahead to what you can expect in 2023.

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31st SOCRA Annual Conference Wrap-Up

We proudly hosted the 31st Annual Conference from September 14-17, 2022, gathering our global clinical research community virtually in an engaging learning and networking environment. This year’s event was brimming with more experts, content, networking and learning opportunities as part of our commitment to offer new ways to learn, grow, and connect with other clinical research professionals.

We were thrilled with this year’s attendance and energy as we shared ideas to promote safe, efficient, and high-quality clinical research. We also hosted award presentations recognizing our members’ steadfast dedication to advancing this ever-evolving field.

In case you missed this year’s conference, we’ve summarized the event in this wrap-up post featuring conference highlights, themes, and special recognition award winners.  Also, as a benefit to our broader clinical research community, plenary session recordings from this conference (and past conferences) are available on our website here.

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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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An Inspiring Interview with SOCRA’s 2022 Recipient of the President’s Special Recognition Award for Distinguished Service: Nancy Wintering, MSW, LCSW, CCRP

From September 14 to September 17, 2022, our global clinical research community will gather virtually for SOCRA’s 31st Annual Conference to enjoy an engaging learning and networking experience to promote safe, efficient, and high-quality clinical research.

At the event, we will honor this year’s President’s Award recipient Nancy Wintering, MSW, LCSW, CCRP, for outstanding service and dedication to SOCRA’s mission. Nancy is the Assistant Director of Research for the Marcus Institute of Integrative Health at Thomas Jefferson University. Nancy has served SOCRA in many ways, including as a past board member, SOCRA Source Journal author, Annual Conference speaker and session chair, workshop and conference organizer and speaker, and poster presenter.

We caught up with Nancy to discuss her thoughts on clinical research, SOCRA, the future, and much more. Read on for interesting insights and perspectives in this inspiring interview.

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Cultivating an Effective Research Team Through Application of Team Science Principles

Shirley L.T. Helm, MS, CCRP Senior Administrator for Network Capacity & Workforce Strategies

C. Kenneth & Dianne Wright Center for Clinical and Translational Research

Virginia Commonwealth University

Abstract: The practice of team science allows clinical research professionals to draw from theory-driven principles to build an effective and efficient research team. Inherent in these principles are recognizing team member differences and welcoming diversity in an effort to integrate knowledge to solve complex problems. This article describes the basics of team science and how it can be applied to creating a highly-productive research team across the study continuum, including research administrators, budget developers, investigators, and research coordinators. The development of mutual trust, a shared vision, and open communication are crucial elements of a successful research team and research project. A case study illustrates the team science approach.

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