Study Coordinator

University of California SystemLos Angeles, CA
78d$33 - $54

About The Position

The Department of Medicine is seeking a detailed and dynamic Clinical Research Coordinator. In this role, you will coordinate research studies, identify participants, and assist the Principal Investigator (PI) with patient eligibility. Responsibilities also include facilitating the informed consent process, educating participants about protocol requirements, and emphasizing the significance of protocol compliance. The role requires maintaining all necessary documentation in accordance with FDA regulations, Good Clinical Practice (GCP) guidelines, and the funding source. This includes managing patient registration, data, and treatment assignment. This role will involve quality control and assurance activities related to study workflows and documentation. In addition, the Clinical Research Coordinator is responsible for procuring and distributing study supplies, including coordinating specimen collection and shipping. Ensuring the safe and accurate completion of protocol-required procedures according to regulatory guidelines, FDA CFR, GCP, and institutional best practices is essential.

Requirements

  • Bachelor's Degree or 1-3 years of previous study coordination or clinical research coordination experience.
  • Strong verbal and written communication skills.
  • Strong interpersonal skills to effectively establish rapport and build collaborative relationships.
  • Strong organizational capabilities to manage multiple projects and competing deadlines.
  • Analytical skills sufficient to address problems and identify solutions.
  • Ability to adapt to changing job demands and priorities.
  • Ability to work flexible hours to accommodate research deadlines.
  • Ability to respond to situations in a professional manner.
  • Ability to concentrate in a distracting work environment.
  • Ability to handle work delegated by more than one individual.
  • Working knowledge of the clinical research regulatory framework and institutional requirements.
  • Mathematical skills sufficient to prepare clinical research budgets.
  • Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GCP).
  • Availability to work in multiple environments and travel to meetings, off-site visits, and conferences.

Responsibilities

  • Coordinate research studies and identify participants.
  • Assist the Principal Investigator (PI) with patient eligibility.
  • Facilitate the informed consent process.
  • Educate participants about protocol requirements.
  • Emphasize the significance of protocol compliance.
  • Maintain all necessary documentation in accordance with FDA regulations and GCP guidelines.
  • Manage patient registration, data, and treatment assignment.
  • Conduct quality control and assurance activities related to study workflows and documentation.
  • Procure and distribute study supplies.
  • Coordinate specimen collection and shipping.
  • Ensure the safe and accurate completion of protocol-required procedures according to regulatory guidelines.

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What This Job Offers

Job Type

Full-time

Industry

Educational Services

Education Level

Bachelor's degree

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