Clinical Research Coordinator 1

The University of Miami’s Clinical Translational Research Site is hiring an entry-level Clinical Research Coordinator 1 to support clinical research protocols and study timelines. The role coordinates participant-facing activities, data collection, regulatory documentation, and routine study operations while following research protocols and regulatory requirements.

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 the appropriate fundamental requirements of all international, national, and local regulatory bodies
• Knows the contents and maintenance of study-specific clinical research regulatory binders
• 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
• Conducts or supports the informed consent process only after training, competency validation, and delegation; ensures current IRB-approved documents are used and filed
• Collects, enters, verifies, and maintains study data in approved systems; completes source documents and CRFs/eCRFs and responds to routine queries
• Communicates routine study updates, scheduling needs, missing documentation, and risks to the PI, supervisor, and study team
• Prepares and routes routine IRB submissions, amendments, continuing reviews, closures, and supporting documents under supervision
• Collects and maintains CVs, licenses, training certificates, financial disclosures, delegation records, credentialing materials, safety reports, and other essential documents
• Assists with sponsor/CRO document requests, site qualification, activation, monitoring visits, audits, and close-out activities
• Performs routine quality-control checks of source documents, data, consent records, and regulatory files; corrects deficiencies using approved processes
• Maintains inspection-ready records for assigned tasks and completes remediation before independent performance when competency has not been demonstrated
• Demonstrates learning agility, reliability, professional communication, teamwork, time management, and responsiveness to coaching
• Participates in onboarding, shadowing, direct observation, mock exercises, and competency reassessment; seeks assistance before acting outside training or delegation
• Travel across different locations if necessary

Preferred

• Bilingual in English and Spanish is preferred but not required
• Bilingual in English
• Spanish

Benefits

• Medical benefits
• Dental benefits
• Tuition remission

Company

• Private research university offering undergraduate and graduate education.
• Miami, Florida, USA
• https://welcome.miami.edu/
• Founded in 1925
• 5001-10000 employees

Qualifications

• 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
• Commitment to the University's core values
• Ability to work independently and/or in a collaborative environment
• Bilingual in English and Spanish is preferred but not required

Required skills

• Bilingual English and Spanish, Clinical Research, Work Organization and Prioritization

Experience

• 1+ years