Clinical Research Coordinator 2

University of Miami•Miami, FL

7d•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 supports the planning, coordination, implementation, monitoring, and evaluation of clinical research studies. The role supports day-to-day protocol operations and study coordination from initiation through close-out, following regulatory and sponsor guidelines. The coordinator works with study team members, staff, faculty, and study sites to promote participant safety, adherence to approved protocols, effective information flow, and coordination of study activities and personnel. The position supports ongoing single-site and multisite research projects with the ID Research Unit Principal Investigator and Project Directors. It serves as the lead coordinator for research activities, including assigning visits to research staff, leading team meetings and trainings, and reviewing protocols. The coordinator also supports study procedures, participant recruitment and retention, informed consent, visit scheduling and conduct, data and specimen handling, study documentation, regulatory compliance, and participant confidentiality.

Requirements

Bachelor’s degree in a relevant field.
At least 2 years of relevant experience.
Ability to learn new procedures, technologies, and protocols and adapt to changing priorities and work demands.
Ability to collaborate with others and contribute to a team environment.
Proficiency with office software, technology, and relevant computer applications.
Strong written and verbal communication skills for interacting with colleagues and stakeholders.

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 protocol requirements, standards, and regulations.
Maintain study binders, filings, visit tracking logs, visit schedules, and regulatory documents in accordance with protocol, institutional, departmental, and sponsor requirements.
Distribute study drug materials according to practice standards and clinical credentials, as delegated by the Principal Investigator.
Monitor, document, report, and follow up on unanticipated or adverse events and protocol deviations.
Assist with implementing protocol amendments under the Principal Investigator’s direct supervision.
Support study orientation and protocol-related in-services for research team members and clinical staff.
Monitor protocol implementation and study progress, keep investigators informed, and submit progress reports on schedule.
Coordinate communications and interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
Assist with study personnel administration, including orientation, competency documentation, certification mandates, safety and responsible-conduct-of-research education, and performance reviews.
Apply cultural competency guidelines and strategies to address participants’ language translation and health literacy needs.
Work with the ID Research Unit Principal Investigator and Project Directors on ongoing project needs and deliverable deadlines.
Coordinate visit assignments for clinical research coordinators, research associates, and volunteers; lead regular team meetings, trainings, and protocol reviews.
Participate in reviewing, revising, and implementing standard operating procedures, and train new research personnel in study activities.
Obtain informed consent and explain study procedures to participants clearly and ethically.
Schedule, prepare for, and conduct participant study visits in accordance with study protocols.
Perform study assessments, including administering questionnaires, conducting interviews, and collecting 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 retention strategies, including participant outreach, appointment reminders, and community engagement activities.
Maintain visit documentation and quality control according to standardized operating procedures.
Protect participant confidentiality and data security according to IRB-approved procedures.
Follow applicable international, national, and local regulatory requirements; maintain required safety, equality, responsible conduct of research, continuing education, and research competency training; and comply with University and unit policies and procedures.