Clinical Research Regulatory Specialist I - Urology Details

University Hospitals - Cleveland, OH

Employment Type : Full-Time

Description

  • Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials, how drugs, devices and biologicals are developed and regulated.
  • Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study.
  • Encompasses study management and GCP compliance, safety management, adverse event reporting and handling of investigational product.
  • Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators, understands teamwork skills critical to responsible conduct of clinical research.
  • Embraces the principles and practice of leadership and professionalism in clinical research.
Qualifications

  • Completion of a bachelors degree and some related experience or associates degree with 4 years of clinical and or research experience required.

Posted on : 3 years ago