Looking for a job

Karina Hex

@karinaomegahex

Message

I am a carbon-based perception algorithm - a self-aware holographic fractal of the Universe in it's entirety.

United States

Message

What I'm looking for

I'm looking to apply my clinical research, quality improvement, and change-management experience to initiatives in cell therapy, gene therapy, immuno-oncology, and longevity fields. The role I am interested in is Director of Clinical Research, and I prefer to work for companies on the cutting edge of innovation.

I've led clinical research studies across more than 70 drug and device trials at Mayo Clinic of Florida, from feasibility and start-up through close-out. My work has supported cardiovascular, kidney disease, infectious disease, anesthesiology, and COVID-19 convalescent plasma research.

As a Clinical Research Associate at Thermo Fisher Scientific CRG, I performed clinical monitoring and site management, assessed protocol and regulatory compliance, and helped ensure audit readiness, subject well-being, and reliable data. I also built collaborative relationships with investigational sites across sponsor and monitoring environments.

Through Alpha Omega Hex Consulting, I apply healthcare and clinical research quality-improvement experience to create adaptable change-management practices. I'm especially interested in lifespan elongation, cell therapy, gene therapy, and immuno-oncology.

Experience

Work history, roles, and key accomplishments

Current

Founder/CEO

Current

Alpha Omega Hex Consulting, LLC

Jul 2023 - Present (3 years 2 months)

Leads an interdisciplinary advisory service, utilizing quality improvement experiences in Healthcare and Clinical Research to create change management practices and offer innovative solutions for growth and sustainability.

Change Management Quality Improvement Consulting Advisory Non Zero Sum Methods

Clinical Research Associate

Thermo Fisher Scientific CRG

Mar 2022 - Apr 2026 (4 years 1 month)

Performs and coordinates clinical monitoring and site management, conducts remote or on-site visits to assess protocol and regulatory compliance, and ensures audit readiness.

Clinical Monitoring Site management Regulatory Compliance ICH GCP SOPs Audit Readiness

Certified Clinical Research Coordinator

Mayo Clinic of Florida

Jan 2016 - Jul 2021 (5 years 6 months)

Independently directed large, complex, multicenter clinical studies in compliance with FDA regulations and institutional guidelines, managing research activities and subject participation.

Clinical Research FDA Regulations Protocol Management Data Management Recruitment Retention Statistical Methods IRB Submission

Special Project Associate

Mayo Clinic of Florida

Nov 2013 - Dec 2015 (2 years 1 month)

Conducted a patient monitoring device study in the Department of Anesthesiology, executing study procedures and managing data collection and analysis.

Clinical Research Patient Monitoring Data Collection GCP Database Management

Research Assistant

Florida International University

Dec 2010 - Aug 2013 (2 years 8 months)

Conducted research in the Biomedical Engineering laboratory focusing on targeted nanoparticle drug delivery methods, including cell culture and animal model testing.

Nanoparticles Cell Culture Animal Models Laboratory Research Database Management