A “WIN” for FDA’s ORA Women Investigators

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.  

About Andrace De Yampert, MS

Andrace’s journey in the clinical research field began as a laboratory technician, and then she advanced in various roles, including study coordinator, project manager, and clinical monitor. Feeling like she’s “grown up in the clinical research family,” Andrace developed a passion for the field and a strong commitment to protecting human subjects. She pursued further education by going to graduate school, where she studied regulatory affairs, compliance, and the overall integrity of data protection. Andrace aimed to ensure that human protection remained at the forefront of clinical research.  

Andrace’s passion led her to join the FDA, where she is surrounded by like-minded individuals who share her commitment to human subject protection and consumer safety. With close to a decade of experience at the organization, she has been integral to advancing the FDA’s mission to promote and protect public health by ensuring medical product safety, efficacy, and quality. As WIN Vice Chair, Andrace’s dedication and expertise in clinical research continue to inspire and drive progress toward a safer and more equitable future for all. 

Empowering Women Investigators: A look inside WIN 

History of WIN

Founded in March 2022, WIN was created by Emilie Kahn to support FDA ORA women investigators and promote a sense of community among them. Emily’s vision for WIN was to provide a space where women could learn together, share experiences encountered during inspections, and uplift each other professionally and personally. The idea for the program was born from discussions that Emily had with other FDA ORA investigators from different commodities. Today, WIN has become a place where women can find camaraderie, learn work-life balance strategies, and receive support from their colleagues. 

Andrace noted that the program’s March launch alignment with Women’s History Month was not a coincidence but a deliberate effort to recognize the significant contributions of women investigators throughout history. 

“Looking back to the origins of FDA women investigators, we can see the pivotal role played by trailblazers like Imogene Golinger Tibbetts and Alma LeVant Hayden,” said Andrace. Imogene was the first female investigator hired by the FDA, appointed in June 1965, shortly after the Civil Rights Act of 1964 prohibited discrimination. Last year, Andrace and the WIN community celebrated her during Women’s History Month, recognizing the incredible legacy of the women who came before them. 

“Alma LeVant Hayden was another groundbreaking woman in the agency who played a critical role in advancing FDA drug analytics capabilities in the 1950s and 60s,” she continued. “By acknowledging these historical contributions, we can appreciate the impact of our work with WIN as we help pave the way for future generations.” 

Mission of WIN 

WIN is an employee-led resource and network group comprised of ORA Investigators and members across ORA and FDA centers. Andrace explained that WIN focuses on topics related to helping to support the professional development of women investigators in ORA, leadership training, personal empowerment, safety, and inclusion of women investigators in ORA field offices around the country. 

WIN supports FDA women investigators in the following areas:  

• Career advancement – WIN organizes networking events to facilitate sharing of knowledge, expertise, and essential interpersonal skills for investigators to succeed in their careers. 
   
• Work-life balance – WIN creates a platform for mentoring and exchanging strategies to manage domestic and international travel while achieving a work-life balance. 
   

• Workplace diversity – WIN assists FDA in recruiting talent and retention through outreach and raising organizational awareness. 
   
• Fieldwork advocacy – WIN serves as an advocacy voice for ORA’s women investigators and promotes a secure and inclusive work environment across all ORA field offices.  

“Through WIN membership meetings and events, we empower women professionally and personally,” said Andrace. “We provide our membership body with many leadership, networking, and coaching opportunities. For example, when a member is taking on a new project for the first time, especially a large one, we’re here to help them to succeed. We also help our members with work-life balance and other uplifting support.”  

Within WIN, Andrace explained that its members have access to five sub-committees focusing on travel, safety & work-life balance, women of color, career development, membership, and an alumni committee for former FDA ORA women investigators who have transitioned to other roles.  
 

“Being a part of WIN has not only provided me with opportunities for professional development, but it has also allowed me to form meaningful connections,” Andrace added. “I couldn’t be prouder of our progress over the last two years. Our network has grown significantly, and we have been able to provide valuable resources and support to women investigators in ORA field offices across the country. Seeing our impact in creating a more inclusive and supportive environment for women in the agency has been gratifying. I look forward to continuing to work with the WIN team and contributing to the growth and success of the program.

How to get involved in WIN

WIN is a perk of working at the FDA,” said Andrace. “So, the best way to get involved with the program is to join the agency. It’s not a network you have to wait to join – once you’re in the FDA family, you have instant access to this collaborative and supportive group of women. We’re always looking for new ideas and contributions.”  

As one of three program experts in OBIMO), Andrace says she’s thankful she landed there. The FDA-wide Bioresearch Monitoring (BIMO) Program is responsible for ensuring the protection of the rights and welfare of human subjects and animals involved in FDA-regulated research and the quality and integrity of data submitted to the FDA in support of new product approvals and marketing applications. Under the leadership of OBIMO’s Program Director Chrissy Cochran, PhD, OBIMO oversees all domestic and foreign field inspectional operations of clinical and nonclinical research conducted in support of marketing applications for FDA regulated products across all centers 
. 

For those interested in joining OBIMO, the agency currently has multiple vacancies for consumer safety officers (investigators) throughout the US. Learn more about the open positions and discover what FDA investigators observe during on-site inspections.