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Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality

Clinical research administration is much like an orange-remove the peel, and what appears to be simple is actually many interconnected, but separate, sections.

Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality (Physical)
SKU: 9781-938835-54-4
$44.95
Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality (MOBI)
SKU: 9781-938835-57-5
$44.95
Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality (EPUB)
SKU: 9781-938835-55-1
$44.95
Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality (PDF)
SKU: 9781-938835-56-8
$44.95

Clinical research administration is much like an orange-remove the peel, and what appears to be simple is actually many interconnected, but separate, sections.

Investigators conducting clinical research trials must manage the myriad administrative aspects of the research enterprise. New investigators often underestimate the time commitment and resources that research management requires. Clinical research professionals must manage this complicated process while fostering productive environments and relationships and also navigating regulation, compliance, and the institutional review board.

Filled with tools, techniques, and templates, Business Administration for Clinical Trials provides research professionals a road map and deeper understanding of strategic planning, financial management, and regulatory implementation to successfully conduct clinical research trials. Cavalieri and Rupp share their highly practical and easily adaptable tactics for developing an effective administrative infrastructure and designing a study down to the granular level. This book will help you:

  • Develop Business plans
  • Negotiate study contracts
  • Navigate regulatory approval processes
  • Secure resources, testing service, and support
  • Foster professional relationships
  • Manage revenue cycles
  • Put regulations into practice
  • Implement effective quality-control processes

About the Authors

R. Jennifer Cavalieri, BSN, RN, CCRC, CCRP, is the Nurse Coordinator of Clinical Research Projects in Infectious Diseases section at the University of Nebraska Medical Center, and she has been a research nurse for more than 20 years. Her experience includes coordinating clinical research trials sponsored by the pharmaceutical industry, federal agencies, and investigator-initiated trials. She has also worked as a dedicated subject recruiter and manager of a clinical trials office.

Mark E. Rupp, MD, is Professor and Chief of Infectious Diseases and Medical Director of the Department of Infection Control and Epidemiology at the University of Nebraska Medical Center. His research experience includes leading numerous infectious disease bench and clinical trials as the Principal Investigator. Dr. Rupp is Past President of the Society of Healthcare Epidemiology of America (SHEA) and has authored more than 100 peer-reviewed scientific papers. He was the Medical Director for a hospital-based clinical trials office and has served as an advisor for the CDC, FDA, NIH, and VA.