One thing can be said for Edye Edens - she’s passionate.

Edye is a licensed attorney with an international human rights, research ethics, and health law background. She spent almost a decade in-house within the academic medical center research compliance environment before transitioning to consulting in 2017. Her consulting areas with First Class Solutions, Inc., include research administration, healthcare compliance, grants, contracts, IRB, COI, education, privacy, HIPAA, multiple areas of FDA compliance related to drugs, devices, and food; AAHRPP, misconduct and site-level compliance work as it relates to QA, monitoring, and auditing (particularly oncology).

Services provided include education and training, program creation and management, or even as a complete outsourcing solution. Additionally, Ms. Edens regularly publishes articles and speaks at regional and national professional research and compliance association meetings, including HCCA, SCCE, PRIM&R, MAGI, AAHRPP, SPARC, RAPS, and AHLA, and teaches at Indiana University McKinney School of Law.

Esthefany Jabbour’s research career started in early 2013, working in regulatory affairs at a site level. In the last few years, she has gained experience in multiple roles at a site level from clinical research coordinator to chief Operations Officer. Her role as a COO at a research site oversaw the site network operations, recruitment, training, business development, and day-to-day structure and management. Her passion in clinical research and business has grown over the years and allowed her to expand her knowledge in multiple therapeutic areas. Recently, she started her own multi-specialty clinical research site in Boca Raton, FL. FWD Clinical Research is data driven site that focuses on delivering quality clinical trials to sponsors.

In this episode, we discuss the challenges and complexity of starting your own research site.

Our guest today does not come from the clinical research world, but instead offers an invaluable service to sites and networks. Brandy Bailey, MA, Director of Strategic Growth for SendaRide has a bachelor’s degree in business administration from Northeastern State University and a master’s degree in gerontology from the University of Central Oklahoma where Brandy graduated with honors. Brandy is currently pursing her second graduate degree, a masters in business administration from Southeastern Oklahoma State University. 

If you aren’t looking for partnerships to better your site or site network, you’re doing it wrong. I, personally, can’t say enough about SendaRide. After working with them we, have seen enrollment and retention increases that help both data quality as well as the bottom line. The ability to offer reliable transportation for your research subjects should be another tool in your site tool belt and nobody does it better than SendaRide.

Jesyln Atanu is a highly dedicated research professional with a range of experience from patient recruitment to working as a CRA, mentoring Clinical Researchers, and training Clinical Research staff on key subject matters. Jeslyn runs a clinical research service, HTex Clinical, that assists research sites in meeting their recruitment goals by providing them with protocol specific patient recruitment & retention consultation.

In this episode, we discuss specialization vs generalization (shades of Dan Sfera), the advantages of networking to acquire knowledge, and the significance of approaching your clinical research career (and life) with openness. This has been one of my favorite conversations to have and Jeslyn is truly an inspiration in the field.

Mario Sierra has a background in biochemistry and business. He currently works at Research Source as a clinical research coordinator and Business Strategist at Paramount Research Network. I’ve had the pleasure of getting to know Mario outside of the podcast and he has a bright future in the clinical research industry.

In this episode we discuss his purposeful entry into clinical research, the adoption of e-source, and the slow adoption of technology across clinical research.

Ethan Seville is a clinical research professional who has worked in a wide range of indications across various roles such as patient recruitment, coordinating, quality assurance, management, and regulatory. Ethan is now the Senior Director of Site Engagement for Slope.io, which helps researchers by ensuring their network of clinical trial patients get the exact medical supplies their care requires on time, on schedule and on budget.

In this episode we discuss innovation at the site-level, collaboration with larger institutions and how Slope.io can help sites manage their supplies, documentation and beyond.

Kim Talbot is the founder of PRN of Kansas, a multi-specialty, stand-alone research site in Wichita Kansas. Kim has a BSN from Wichita State, and has been an APRN since 2001.

In this episode we talk about the importance of developing a diverse study pipeline, what makes a good research coordinator, and the day-to-day of a research site owner.

Jeffrey Smyth is the VP/COO for MOORE Clinical Research in Tampa, Florida. He has held the position since 2011 and has a Master’s in Healthcare Administration.

Jeffrey and MOORE Clinical Research have recently implemented an e-source solution across their company. This episode discusses the challenges, rewards and issues involved with implementing e-source.

Lucia Rodriguez and Bianca Garcia have worked in clinical research for well over 20 years combined. They’ve held just about every site-level title and worked across all phases, multiple therapeutic areas, and numerous. Basically - these ladies know their stuff. Recently they have teamed up to star their own company - Absolute Clinical Research. Absolute Clinical Research offers an individualized, customer-focused approach to clinical research management while maintaining patient safety and protection, protocol adherence, quality of data as top priorities.

In this episode we discuss the importance of constant communication, starting your own company while working full time, investing in your staff, and why you should always be prepared.

Mone’ Brown is a well rounded clinical research professional who has a passion in many different areas of clinical research. Her passion is Regulatory Affairs in addition to monitoring. She has held roles from Regulatory Affairs Document Specialist, Clinical Research Coordinator as well as Project Manager. She holds a Master's of Science in Regulatory Science. She was unfortunately laid off in March of 2020. Someone hire this woman before it’s too late!

In this episode we discuss the jump from CRC to CRA, the delicate balance between quantity and quality, the value of diversifying your experience, the challenges of job hunting during a pandemic and the importance of integrity.