Clinical Research Coordinator 2

Current Employees:

If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. 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. 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. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.

CORE RESPONSIBILITIES

• Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
• Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
• Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
• Maintains study binders and filings according to protocol requirements, UM and department policy.
• Distributes study drug materials according to practice stand6ards and clinical credentials as delegated by the Principal Investigator.
• Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
• Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
• Assists with study orientation and protocol related in-services to research team and clinical staff.
• Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
• Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
• 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.
• Follows the appropriate 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.

Department Specific Functions

• 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.
• Oversees collection, processing, storage, and shipment of biological specimens (blood, sputum, etc.) following sponsor protocols, IATA guidelines, and institutional policies.
• 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 a