University of Miami
Healthcare
ClinicalResearchCoordinator1
Neural analysis suggests this role is
optimal for Entry candidates.
“Clinical Research Coordinator 1 at University of Miami. Skills: Clinical research, Protocol management, Participant advocacy. Perform chart review/pre-screening. Maintain enrollment procedures”
Industry & Context.
Problem solves operational failures; Problem solve protocol deviations; Problem solve unanticipated occurrences
Travel might be required
What They're Looking For.
Must Have
Bachelor's degree in relevant field, Minimum 1 year of relevant experience, Skill in completing assignments accurately, Ability to analyze, organize and prioritize work, Ability to process and handle confidential information, Ability to work evenings, nights, and weekends, Commitment to the University's core values, Ability to work independently and/or in a collaborative environment
Nice to Have
Bilingual in English and Spanish
What You'll Do.
Perform chart review/pre-screening
Maintain enrollment procedures
Coordinate routine activities
Schedule appointments
Schedule study visits
Perform research tests
Perform research experiments
Adapt procedures for quality improvement
Understand technical instructions
Operate clinical research equipment
Problem solve operational failures
Observe adverse events
Inform PI/supervisor of adverse events
Address adverse events per protocol
Advocate for study participants
Maintain quality standards
Identify protocol deviations
Report protocol deviations
Problem solve protocol deviations
Identify unanticipated occurrences
Report unanticipated occurrences
Problem solve unanticipated occurrences
Follow regulatory body requirements
Maintain study-specific regulatory binders
Maintain requisite skills
Complete mandatory training
Adhere to University policies
Adhere to unit-level policies
Safeguard University assets
Assist in participant recruitment
Assist in participant retention
Assist in screening participants
Maintain study binders
Maintain study filings
Distribute study drug materials
Assist in implementing protocol amendments
Assist with study orientation
Assist with protocol-related in-services
Monitor protocol implementation
Keep investigators apprised of study progress
Submit progress reports
Assist with communications/interactions
Assist with administrative tasks
Document core competencies
Document certification mandates
Document safety education
Document responsible conduct education
Document performance reviews
Adhere to cultural competency
Implement strategies for translation
Implement strategies for health literacy
Follow regulatory requirements
How You'll Work.
Team & Collaboration
Collaborative environment; Research team; Clinical staff; Sponsors; Data coordinating centers; Compliance monitors; Collaborators; Investigator's personnel; Academic personnel; Administrative personnel; Departments
Process & Methodology
Plan study timelines, Schedule appointments, Schedule study visits, Schedule meetings, Project evaluation
Full Job Description
**_Current Employees:_** If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click [here](https://www.myworkday.com/umiami/d/task/1422$7248.htmld) 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](https://my.it.miami.edu/wda/erpsec/tipsheets/ER_eRecruiting_ApplyforaJob.pdf). The Clinical Translational Research Site is currently seeking a full time Clinical Research Coordinator 1 to work in Miami. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines. **CORE 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. * Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation. * 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, problem solves when operational failures occur. * Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants. * Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. * Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences. * Follows
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