Our Priority,
From The Start

Hart Clinical Consultants (HCC), established in 2011 by Jim Hart, embarked on its journey as a crucial staff augmentation service aimed at supporting medical device companies in conducting clinical studies. Under the visionary leadership of Jim Hart, who also serves as the CEO, HCC has since evolved into a distinguished Contract Research Organization (CRO) known for its exceptional guidance and support throughout all phases of clinical research.

With a rich foundation rooted in decades of industry experience, HCC has grown into a full-service CRO. The organization prides itself on being a reliable clinical partner as well as a prudent business ally, emphasizing the careful management of resources and prioritizing client projects as our own.

Today, HCC stands as a beacon of excellence in the CRO landscape, offering a comprehensive suite of clinical and regulatory services designed to adeptly navigate both US-centric and global clinical studies. The company's mission extends beyond mere operational support, raising the bar for world-class clinical research.

Leading the Way

Jim Hart

Jim Hart, the founder, President and CEO of Hart Clinical Consultants, LLC (HCC) has an extensive background in medical device clinical research and sales.  With over 25 years of industry experience Jim’s expertise extends to managing a high-volume cardiac and endovascular interventional lab.   His strategic planning acumen and passion for excellence serve as the foundation for HCC’s leadership and guidance.

Before establishing HCC, Jim enjoyed success at the legacy companies Advanced Cardiovascular Systems (ACS) and Guidant Corporation, as well as Abbott Vascular.  His unwavering dedication to advancing healthcare drives growth and success for HCC, with a focus on enhancing medical device technology and ultimately improving patient outcomes.

Jim holds a BS degree from the University of Central Florida and is a Certified Clinical Research Associate (CCRA) recognized by the Association of Clinical Research Professionals.

Dan Beck
Quality Director

Dan Beck serves as Director of Clinical Quality Assurance at Hart Clinical Consultants and has over 14 years of expertise supporting project quality, risk management and client ROI.  Built upon 30+ years of industry experience, Dan brings a comprehensive understanding of clinical quality to uphold the highest standards across company operations.  

Dan has held pivotal clinical affairs, project management, regulatory and R&D roles across large, medium, and start-up companies spanning pre-clinical through Phase IV device and pharma trials for cardiovascular, neuro / neurovascular, and ophthalmologic applications.  All post-dating tenure in a hospital biomedical department including as an interventional Cath lab CVT.    

Dan holds a B.A. in Biology, Chemistry and Physics from Drury University, Springfield MO, as well as post-graduate Biomedical studies at Southwest Missouri State University.

Karina Brennecke
Program Management Director

Karina Zarins Brennecke is Senior Director of Program Management at Hart Clinical Consultants.  She has over 20+ years of clinical research experience in biotechnology, medical device, pharma and diagnostic industries worldwide. Karina’s expertise in strategic planning, clinical design and development and stakeholder communication ensures seamless execution of research programs.

Prior to joining HCC, Karina previously held lead roles in program management at Verily (a Google spin-off) and clinical affairs at Altura Medical, Auxogyn and Abbott Vascular. Karina provides expertise in FDA regulations, ISO standards, process development and improvement and management and oversight of complex programs. Karina is a highly regarded professional with continuous, successful experience in providing clinical quality and compliance solutions with a proven record of developing successful strategies for industry-leading healthcare companies.

Karina earned her BA from the University of Massachusetts and is a Certified Clinical Research Associate (CCRA).

Nancy Ouch
Safety Director

Nancy M. Ouch leads HCC's Safety Management. Nancy is a dedicated leader in safety management with over 15 years of experience in the medical device, pharmaceutical and biotech industry.  Nancy focuses on compliance, risk assessment, and advancing safety practices, aligning with HCC's mission for high-quality patient care.

 Nancy is committed to fostering a culture of safety oversight and compliance. With a solid background in safety protocols and risk assessment, Nancy ensures that all aspects of operations adhere to regulatory standards. She leverages her experience to implement robust safety management strategies that prioritize team productivity and service integrity, and actively participates in industry forums to stay abreast of emerging safety trends and regulations. Nancy's passion for advancing safety practices aligns with HCC's mission to deliver high-quality, safe medical products that enhance patient care and outcomes.

Nancy holds a biological sciences degree from the University of California in Los Angeles (UCLA) and a health administration master's degree from California State University in Northridge (CSUN).