U

University of Louisville

Research university in Louisville, KY

Clinical Research Coordinator II

Clinical Research OperationsPosted on Nov 13
Full-timeUnited States$17.35 - $26.03In-person

About the Job

Requirements

  • A high school diploma or GED and at least two years of relevant experience, or an equivalent combination of education and experience.
  • Knowledge of and ability to follow study protocols, institutional policies, regulatory requirements, Institutional Review Board requirements, Good Clinical Practice guidelines, and applicable federal regulations.
  • Ability to maintain accurate study documentation, source records, participant logs, and specimen tracking records.
  • Ability to perform data collection, data entry, and quality assurance activities in accordance with study protocols and standard operating procedures.

Responsibilities

  • Coordinate participant recruitment, screening, enrollment, and retention for multiple clinical research studies.
  • Identify and approach potentially eligible participants in inpatient and outpatient clinical settings.
  • Obtain informed consent and maintain ongoing communication with study participants throughout their participation.
  • Collect, process, label, document, store, and transport biological specimens according to study protocols, institutional policies, and regulatory requirements.
  • Maintain chain-of-custody documentation and ensure timely delivery of research specimens to designated Department of Surgery laboratories.
  • Collaborate with investigators, clinical staff, laboratory personnel, and research teams to facilitate study enrollment and sample collection activities.
  • Ensure assigned studies are conducted in accordance with University of Louisville Institutional Review Board requirements, Good Clinical Practice guidelines, applicable federal regulations, and institutional policies.
  • Maintain accurate and complete study documentation, source records, participant logs, and specimen tracking records.
  • Perform data collection, data entry, and quality assurance activities in accordance with study protocols and established standard operating procedures.
  • Assist with preparation and maintenance of regulatory documents, study files, and Institutional Review Board submissions as needed.
  • Communicate study requirements and participant schedules with investigators, research staff, and clinical teams to ensure successful study implementation.
  • Support monitoring visits, audits, and quality assurance activities by maintaining organized and compliant study records.
  • Maintain inventory and supplies necessary for participant enrollment, specimen collection, processing, and storage.

About the Company

University of Louisville

Research university in Louisville, KY

University of Louisville is a public metropolitan research university in Louisville, Kentucky. It offers undergraduate, graduate, doctoral, and professional programs through its schools and colleges.

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