University of Miami

University of Miami

Clinical Research Coordinator 2

Miami, FL · Staff+ · Contract

Sponsorship not specifiedDetected 12 hours ago
GCPComplianceHRISHIPAAClinical TrialsClinical ResearchHealth LiteracyPatient CareFDA RegulatoryResearchCommunication

About the role

  • To learn how to apply for a faculty or staff position, please review this tip sheet.
  • The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work on the UHealth campus.
  • The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies.

Responsibilities

  • Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
  • Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
  • Maintains study binders and filings according to protocol requirements, UM and department policy.
  • Supports recruitment, prescreening, and enrollment of participants across pulmonary, critical care, and sleep medicine clinical trials, including studies involving COPD, asthma, ILD, bronchiectasis, and sleep disorders.
  • Coordinates and performs study visits and procedures in accordance with protocol requirements, including pulmonary function testing coordination (PFTs), six-minute walk tests, biospecimen collection, and patient-reported outcome assessments.
  • Maintains accurate and audit-ready regulatory binders and study files in accordance with UM, sponsor, and FDA/ICH-GCP requirements.
  • Supports investigational product (IP) handling and accountability (when applicable), including coordination with IDS/pharmacy and ensuring proper documentation per protocol.
  • Monitors, documents, and reports adverse events (AEs/SAEs), protocol deviations, and unanticipated problems, ensuring timely reporting to sponsors, IRB, and regulatory bodies.
  • Implements protocol amendments, including updating study documents, revising workflows, and reconsenting participants as needed under PI supervision.
  • Serves as a point of contact for sponsors, CROs, monitors, and internal collaborators; supports effective communication and issue resolution across cross-functional teams.

Requirements

  • Bachelor's degree in relevant field required
  • Minimum 2 years of relevant experience required
  • Collaborates with clinical teams (physicians, RTs, nurses) to coordinate protocol-required procedures during routine patient care and research visits.

Skills

  • Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
  • Skilled in using office software, technology, and relevant computer applications.
  • Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

Benefits

  • Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
  • Adheres to cultural competency guidelines; implements strategies to meet study participants' needs for language translation, health literacy, etc.
  • Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.

Visa & Work Authorization

  • This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines.
Apply directly at University of Miami →Create a free account for alerts like thisView University of Miami immigration profile

This listing is sourced directly from University of Miami's careers page and normalized into a canonical job model.