About The Position

The Clinical Research Coordinator 1 position at the University of Miami is an entry-level role within the Division of Infectious Diseases, focusing on supporting clinical research activities. The coordinator will manage data, implement clinical research protocols, and ensure compliance with regulatory standards while advocating for study participants. This role is designed for individuals with a foundational understanding of clinical research, providing opportunities for skill development and increased responsibility in managing simple clinical research protocols.

Requirements

  • Bachelor's degree in a relevant field.
  • Minimum 1 year of relevant experience.

Responsibilities

  • Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
  • Maintains enrollment procedures according to the protocol and coordinates routine activities of clinical studies including data collection and maintenance.
  • Plans study timelines, schedules appointments and study visits, and conducts project evaluations.
  • Performs moderate to complex research tests/experiments and adapts procedures for quality improvement under supervision.
  • Understands and follows technical instructions for operating clinical research equipment and problem solves operational failures.
  • Assists in observing and informing the PI/supervisor of adverse events reported by study participants.
  • Addresses adverse events per protocol, advocating for study participants and quality standards throughout the study.
  • Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
  • Follows the fundamental requirements of all international, national, and local regulatory bodies.
  • Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
  • Adheres to University and unit-level policies and procedures and safeguards University assets.
  • Reports to Principal Investigators, Program Director, and Study Coordinators on assigned funded/unfunded research studies.
  • Assists Principal Investigators in all stages of clinical trial procedures at research sites.
  • Develops and maintains all study-specific reporting needs and requirements as established by the IRB, HSRO, DOH, and HIPAA office.
  • Coordinates with various agencies, partners, and lead team investigators on issues regarding future and ongoing protocols.
  • Assists Principal Investigators to maintain and coordinate all relevant research databases and related activities to ensure accurate data entries.
  • Assists Principal Investigators in the publication of significant results including authorship of scientific monographs.

Benefits

  • Medical insurance
  • Dental insurance
  • Tuition remission
  • Comprehensive benefits package
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