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Clinical Research Coordinator 1
University of Miami. Perform chart review and pre-screening activities for study participant eligibility .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in coordinating clinical research protocols, managing study data, and adhering to regulatory requirements. Proficient in performing research tests, maintaining inspection-ready records, and communicating effectively with study teams.
Highest-signal resume keywords
Clinical Research CoordinationData Collection and ManagementRegulatory ComplianceAdverse Event ReportingBilingual in English and Spanish
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Chart ReviewResearch TestingData EntryQuality ControlProtocol Deviation IdentificationIRB Submission PreparationClinical Research Equipment OperationCompetency ValidationConfidential Information HandlingStudy-Specific Regulatory Binder Maintenance
Soft Skills
Attention to DetailOrganizational SkillsAbility to Work Under PressureCollaborationDiscretion
Industry Keywords
Clinical ResearchStudy Enrollment ProceduresAdverse EventsRegulatory RequirementsContinuing EducationResearch Competency TrainingSponsor/CRO Document RequestsInspection-Ready RecordsConfidential InformationStudy Visits
About the role
Key responsibilities & impact- Perform chart review and pre-screening activities for study participant eligibility
- Coordinate simple clinical research protocols and maintain enrollment procedures
- Coordinate routine clinical study activities, including data collection, study timelines, appointments, study visits, meetings, and project evaluation
- Perform moderate to complex research tests and experiments under supervision
- Operate clinical research equipment and troubleshoot operational failures
- Observe and report adverse events to the PI or supervisor and address them according to protocol
- Identify, report, and help resolve protocol deviations and unanticipated occurrences
- Follow international, national, and local regulatory requirements
- Maintain study-specific clinical research regulatory binders
- Maintain mandatory safety, equality, responsible conduct of research, continuing education, and research competency training
- Collect, enter, verify, and maintain study data in approved systems; complete source documents and CRFs/eCRFs and respond to routine queries
- Communicate study updates, scheduling needs, missing documentation, and risks to the PI, supervisor, and study team
- Prepare and route routine IRB submissions, amendments, continuing reviews, closures, and supporting documents under supervision
- Maintain CVs, licenses, training certificates, financial disclosures, delegation records, credentialing materials, safety reports, and other essential documents
- Assist with sponsor/CRO document requests, site qualification, activation, monitoring visits, audits, and close-out activities
- Perform routine quality-control checks and correct deficiencies using approved processes
- Maintain inspection-ready records and complete remediation before independent performance when competency has not been demonstrated
- Participate in onboarding, shadowing, direct observation, mock exercises, and competency reassessment
- Seek assistance before acting outside training or delegation
Requirements
What you’ll need- Bachelor’s degree in relevant field
- Minimum 1 year 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 process and handle confidential information with discretion
- Ability to work evenings, nights, and weekends as necessary
- Ability to work independently and/or in a collaborative environment
- Must complete training, competency validation, and delegation before conducting or supporting informed consent
- Bilingual in English and Spanish is preferred but not required
- Ability to travel across different locations if necessary
Benefits
Comp & perks- Competitive salaries
- Medical benefits
- Dental benefits
- Tuition remission