About The Position

Responsible for performing diverse administrative and clinical responsibilities requiring some analysis, sound judgment, and a high level of knowledge of specific research study protocols, Good Clinical Practice Guidelines, Federal research regulations, and institutional requirements. Responsible for coordination and management of clinical study protocols and along with the research investigator, manages many aspects of the clinical trial and conducts all research activities within an ethically based framework in accordance with federal, state, and local regulations. Function as a liaison between investigators, subjects and sponsors, the Institution(s), Institutional Review Board (IRB) and Privacy Board.

Requirements

  • Bachelor’s degree in allied health medical field, another related field or licensed LPN
  • Ability to prioritize and complete several tasks/projects simultaneously in strict accordance with regulations, policies, and study protocol
  • Demonstrated effective verbal/written communication skills
  • Analytical skills
  • Attention to details
  • Ability to work independently with minimal supervision
  • Organization/time management skills
  • Project management skills
  • Demonstrated intermediate knowledge of personal computer skills

Nice To Haves

  • One year clinical research experience
  • Clinical Research Coordinator Certification (by either the Association for Clinical Research Professionals or Society of Clinical Research Associates)
  • Knowledge of Good Clinical Practices, U.S. Department of Health and Human Services Protection of Human Subjects and U.S. Food and Drug Administration regulations, International Conference of Harmonization Guidelines, and the HIPAA Privacy Rule as it impacts clinical research

Responsibilities

  • Coordination and management of clinical study protocols
  • Managing many aspects of the clinical trial
  • Conducting all research activities within an ethically based framework in accordance with federal, state, and local regulations
  • Functioning as a liaison between investigators, subjects and sponsors, the Institution(s), Institutional Review Board (IRB) and Privacy Board
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