Clinical Research Coordinator 2

University of Miami•Miami, FL

2d•Onsite

About The Position

The Department of Medicine at the University of Miami is hiring a full-time Clinical Research Coordinator 2 to work on the UHealth campus. This mid-level clinical research professional assists with planning, coordinating, implementing, monitoring, and evaluating clinical research studies. The coordinator supports day-to-day protocol operations and study activities from initiation through close-out, following regulatory and sponsor guidelines. The role works with study teams, staff, faculty, and study sites to protect participant safety, ensure adherence to approved protocols, support administrative work, and coordinate study activities and personnel. For the ID Research Unit, the coordinator works with the Principal Investigator and Project Directors on active multisite and single-site studies to meet deliverable deadlines. The coordinator serves as lead support for research activities, assigns visits to research personnel, and leads regular team meetings, trainings, and protocol reviews. The position also supports study procedures, participant recruitment and retention, regulatory and quality-control documentation, sample tracking, and confidentiality and data-security requirements. Duties may be expanded as necessary.

Requirements

Bachelor’s degree in a relevant field.
At least 2 years of relevant experience.
Skill in completing assignments accurately and with attention to detail.
Ability to analyze, organize, and prioritize work under pressure while meeting deadlines.
Ability to handle confidential information with discretion.
Ability to work evenings, nights, and weekends as necessary.
Commitment to the University’s core values.
Ability to work independently and in a collaborative environment.

Responsibilities

Assist with participant recruitment and retention, and screen potential participants for eligibility.
Perform study procedures, routine tests, data collection and recording, and daily operations for moderate-risk clinical research protocols.
Collect, process, pack, and ship specimens according to protocols, standards, and regulations.
Maintain study binders and files according to protocol requirements and University and department policies.
Distribute study drug materials as delegated by the Principal Investigator and in accordance with practice standards and clinical credentials.
Monitor, document, report, and follow up on unanticipated or adverse events and protocol deviations.
Assist with protocol amendments under the direct supervision of the Principal Investigator.
Assist with study orientation and protocol-related in-services for research and clinical staff.
Monitor protocol implementation and study progress, keep investigators informed, and submit scheduled progress reports.
Support communications and interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
Assist with administrative tasks for study personnel, including orientation, competency documentation, certification mandates, safety and responsible-conduct-of-research education, and performance reviews.
Apply cultural competency practices and strategies addressing participants’ language translation and health-literacy needs.
Follow applicable international, national, and local regulatory requirements; maintain required skills and training; and follow University and unit policies while safeguarding University assets.
Work with the ID Research Unit Principal Investigator and Project Directors on active multisite and single-site study needs and deliverable deadlines.
Lead coordination of research activities, including assigning visits to coordinators, research associates, and volunteers, and leading team meetings, trainings, and protocol reviews.
Participate in reviewing, revising, and implementing standard operating procedures, and train new research personnel in study activities.
Identify, screen, and recruit eligible participants according to inclusion and exclusion criteria.
Obtain informed consent and explain study procedures clearly and ethically.
Schedule, prepare, and conduct participant visits in accordance with study protocols.
Conduct study assessments, including questionnaires and interviews, and collect clinical or behavioral data.
Coordinate with laboratory staff to ensure timely sample processing and tracking.
Ensure study visit forms, source documentation, and participant records are complete and accurate.
Support participant retention through outreach, appointment reminders, and community engagement.
Maintain visit tracking logs and follow standardized procedures for visit documentation and quality control.
Maintain and review study binders, visit schedules, and regulatory documents in compliance with institutional and sponsor requirements.
Protect participant confidentiality and data security according to IRB-approved procedures.