Jim Hart

About Jim Hart

Hart Clinical Consultants (HCC) will assist business partners to provide unparalleled world-class support and service to ensure clinical and regulatory activities are conducted expertly in the conduct of global or US focused clinical trialsHart Clinical Consultants (HCC) is a full-service Contract / Clinical Research Organization (CRO), offering comprehensive clinical trial management services for medical device, diagnostics, and pharmaceutical companies. HCC was founded in 2011 and has therapeutic expertise in cardiology, endovascular, peripheral vascular, neurovascular, pulmonary, urology, and diabetes and mental health areas.HCC is capable of managing global clinical trials with resources in geographies across western and eastern EU, Australia and New Zealand.HCC manages all aspects of trial operations for studies operating under either 312 or 812 regulations from first-in-human studies (phase I) through post-market approval studies (phase IV).HCC specific services include• Comprehensive project management• Comprehensive site management• Comprehensive study monitoring • Expert device training to investigators and hospital support staff and proctoring procedures • Comprehensive data management services• Comprehensive safety management services* Full support of site payment process* Full support of investigational device management* Full support for eTMF maintenance• Technical writing services• Agency BiMo inspection preparedness as requiredOur team of regionally-based Clinical Research Associates (CRAs) and Clinical Specialist (CS) are dedicated to providing professional skill and experience to assist study sponsor meet and exceed study goals.At HCC, we strive to partner with our clients providing “world-class” service and helping our clients feel like “their project is our priority\"

Experience

1. CEO

   Hart Clinical Consultants

   Mar 2011 — Present

Education

• University of Central Florida

  BSN, Nursing

  1996 — 1998

Skills

• Cardiology
• Clinical
• Management
• Electrophysiology
• U.s. Food and Drug Administration (Fda)
• Ctms
• Medical Devices
• Clinical Research
• Gcp and Iso Expert
• Skilled Device Trainer
• Gcp
• Regulatory Submissions
• Nursing
• Life Sciences
• Vascular
• Hospitals
• Clinical Operations
• Good Clinical Practice (Gcp)
• Clinical Trials
• Clinical Development
• Pharmacovigilance
• Hematology
• Clinical Research Operations
• Cross-Functional Team Leadership
• Regulatory Affairs
• Orthopedic
• Clinical Trial Management System (Ctms)
• Healthcare
• Neurology
• Start-Ups
• Diabetes
• Biotechnology
• Pharmaceutical Industry
• Fda
• Product Launch