Employee Spotlight: Meet Mike Grillo, Supporting Clinical Research with Purpose and Precision

Meet Mike!

At HeartWorks, every team member plays an important role in advancing our mission to bring hope to children, adults, and families impacted by congenital heart defects, also known as CHD. In this Employee Spotlight, we are excited to introduce Mike Grillo, whose career in clinical research and dedication to patients and families have made him an important part of the HeartWorks team. 

Mike brings more than 20 years of clinical research experience to HeartWorks, along with a deep appreciation for the people at the center of this work: children with congenital heart disease, their families, caregivers, and the clinical teams who support them. 

A Lifelong Curiosity for Science and Clinical Research 

Mike was born and raised in northern Minnesota. After high school, he spent a year playing junior hockey in Rochester, Minnesota, before attending St. Cloud State University, where he earned a degree in Psychology. His path into science and clinical research began through an internship at the University of Minnesota, which led to employment there and sparked a lifelong interest in research. 

Since then, Mike’s professional journey has touched nearly every area of clinical research. His experience includes roles in academia, the federal government, corporate America, a Contract Research Organization, and now the nonprofit world through HeartWorks. That broad background gives him a unique perspective on what it takes to conduct clinical trials with care, accuracy, and integrity. 

Mike’s Role at HeartWorks 

Mike joined HeartWorks in September 2022. He initially focused on monitoring clinical trials, but his role evolved into one he has held for much of his career: clinical study manager and monitor. In this position, Mike helps ensure that clinical studies are conducted carefully, ethically, and in alignment with internal procedures and federal regulations. 

Clinical research is rarely routine, and Mike’s work reflects that. When clinical trials are actively moving forward, each day can look different. His responsibilities may include coordinating with clinical sites, reviewing documentation, supporting study activities, and ensuring that trial processes remain organized and compliant. 

Recently, Mike has spent a significant amount of time supporting the transition from Mayo to HeartWorks, Inc. This has included work to close out UCB studies at consortium clinical sites. He has also been involved in clinical study preparation for the next phase of HeartWorks’ skin punch clinical trials, including updates to internal SOPs and study documentation. 

For patients and families seeking information about CHD research, clinical trials, and potential future therapies for congenital heart disease, this behind-the-scenes work is essential. It helps create the structure, quality, and reliability needed to move meaningful research forward. 

Inspired by CHD Families and Heart Warriors 

For Mike, one of the most inspiring parts of working at HeartWorks is the opportunity to support children and families affected by congenital heart defects. The strength, perseverance, and spirit of CHD families are a powerful reminder of why this work matters. 

He is also inspired by events like the HeartWorks Virtual Dinner, where families, caregivers, supporters, and team members come together around a shared mission. Hearing family stories and seeing the CHD community united in hope and support reinforces the importance of HeartWorks’ efforts to advance research for congenital heart disease. 

Mike also recognizes the many people who play a role in a Heart Warrior’s journey, including clinical staff and care teams. Their commitment, both within and beyond their institutions, reflects the broader community of support surrounding children and adults impacted by CHD. 

A Commitment to Integrity, Accuracy, and Patient-Focused Progress 

Within HeartWorks, Mike is passionate about conducting clinical trials with integrity, precision, accuracy, and efficiency. Clinical research requires careful attention to detail, strong documentation, and a commitment to doing things the right way. Mike’s experience helps support those standards across HeartWorks’ clinical programs. 

This work is especially important in the field of congenital heart defect research, where patients, families, and caregivers are looking for trustworthy information and meaningful progress. Every study document, every clinical site interaction, and every carefully managed trial activity contributes to the larger goal of advancing potential therapies for children and adults living with CHD. 

Life Outside of Work 

Outside of HeartWorks, Mike enjoys spending time with his family. He and his wife, Debbie, have two children, Mekiah and Liana, as well as two pets, Leo and Bleu. Much of their family time is spent supporting their daughter as she plays softball and competes in horse competitions. 

Mike also enjoys family travel and spending time outdoors. His personal interests include golf, mountain biking, hiking, photography, and visiting the family cabin. Whether he is on a trail, behind a camera, or enjoying time at the cabin, Mike values opportunities to be outside and spend meaningful time with family. 

Looking Ahead 

As HeartWorks continues its mission to advance research and future therapies for congenital heart defects, Mike is excited about the clinical trials ahead. He looks forward to being part of a team working to bring more potential CHD therapies to young children and adults. 

Through his clinical research experience, steady commitment to quality, and patient-focused approach, Mike helps support the foundation needed to move HeartWorks’ mission forward. His work reflects the care, precision, and purpose that are essential to serving the congenital heart defect community. 

 

FAQs: Clinical Research and Study Opportunities at HeartWorks

 

What types of studies is HeartWorks working on?

HeartWorks is advancing research focused on congenital heart disease, including regenerative medicine studies, clinical readiness programs, and patient-specific research initiatives.

What is the skin punch biopsy study?

The skin punch biopsy study collects patient cells that may help support future regenerative medicine research and personalized approaches for congenital heart disease.

What is The Co-op @ HeartWorks?

The Co-op @ HeartWorks is a collaborative platform designed to connect patients, families, and research while helping accelerate innovation and future study opportunities.

Why is participation in CHD research important?

Research participation helps scientists better understand congenital heart disease and supports the development of future therapies and treatment approaches.

How can families learn about future study opportunities?

The best way families can stay connected about the opportunities available for them is through The Co-op @ HeartWorks. The Co-op will alert you specifically when you are eligible. Additional ways include: newsletters, webinars, and updates shared by the HeartWorks team.

What role does clinical operations play in research?

Clinical operations teams help ensure studies are conducted safely, responsibly, and in alignment with regulatory requirements while supporting participating families throughout the process.

Does participation guarantee access to future therapies?

Participation in research does not guarantee access to future treatments, but it helps advance scientific understanding and future possibilities for congenital heart disease care.

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