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The Department of Clinical Translational Research Site, Otolaryngology is currently seeking a full-time Clinical Research Coordinator to work in Miami.
CORE JOB SUMMARY
The Clinical Research Coordinator serves as an mid-level research professional with experience 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 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.
CORE QUALIFICATIONS:
Education:
Bachelor’s degree in relevant field
Experience:
Minimum 3 year of relevant experience
Knowledge, Skills and Attitudes:
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.
Commitment to the University’s core values.
Ability to work independently and/or in a collaborative environment.
Department Specific Functions
Career Stage: Intermediate
Coordinates and independently manages assigned routine-to-moderately complex studies within delegated authority, with access to leadership for complex or higher-risk matters. Routine-to-moderately complex studies are those with a single site, established procedures, industry sponsorship with active monitoring, or multi-arm designs not involving investigational devices or first-in-human elements. Studies meeting CRC 3 portfolio thresholds — as defined in the CTRS Study Complexity Matrix — are assigned with CRC Supervisor co-oversight or leadership.
Independently coordinates priorities, timelines, and communications across multiple assigned studies and/or Principal Investigator teams.
Serves as a routine day-to-day contact for assigned studies. Communicates protocol and participant-specific decisions directly to the PI; routes operational, regulatory, and risk matters to the supervising CRC or CRC Manager per the CTRS Escalation and Decision Authority Matrix.
Exercises judgment within approved protocols, SOPs, delegation, sponsor requirements, and institutional…