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Clinical Research Coordinator

2 months ago


Cincinnati, Ohio, United States University of Cincinnati Full time
Job Overview

The University of Cincinnati is seeking a highly skilled Clinical Research Professional to join our team. As a key member of our research team, you will be responsible for overseeing the start-up process for clinical trials, ensuring compliance with regulatory requirements, and providing exceptional support to our researchers and sponsors.

Key Responsibilities
  • Oversee the start-up process for clinical trials, including feasibility and scientific review processes.
  • Complete initial IRB submissions and assist in preparation of site-adapted informed consent forms.
  • Collect and complete essential regulatory documentation for start-up, including contract and budget submissions.
  • Provide ongoing status reports about studies in the start-up process.
  • Interact daily with sponsors, CROs, and internal UC staff to ensure seamless communication and collaboration.
Requirements
  • Bachelor's degree in a related field or equivalent experience.
  • 1-3 years of relevant experience in an academic, clinical, or laboratory setting.
Preferred Qualifications
  • Knowledge of medical and pharmaceutical terminology and concepts.
  • Experience in an academic or clinical setting in the area of clinical specialization.
  • Excellent communication skills with sponsors, coworkers, and physicians.
  • Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
  • Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheets, New Study Applications, Renewal Applications, IND Applications, etc.
Physical Requirements/Work Environment
  • Sitting - Continuously