Clinical Research Coordinator 2

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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.

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.

• →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.

• →Demonstrates sustained independent coordination of assigned studies, including participant, data, regulatory, monitoring, and close-out responsibilities. 

• →Identifies recurring issues and documents them for the supervising CRC  or CRC Manager, who leads corrective action planning. CRC 2 implements assigned corrective steps within their own portfolio and reports completion. 

• →Demonstrates effective stakeholder communication, reliable judgment, peer support, and readiness for advanced study and portfolio leadership. 

• →Advancement is based on demonstrated competency, performance, study complexity, increased responsibility, professional development, and organizational need; experience alone does not guarantee promotion. Advancement consideration also includes progress toward the CRC 2 certification expectation and readiness for CRC 3 responsibilities. 

• Actively pursuing ACRP (CCRC/ACRP-CP) or SOCRA (CCRP) certification is expected at this level. CRC 2 coordinators are encouraged to obtain certification no later than Year 2 in the role to maintain eligibility for CRC 3 advancement consideration. Certification is required at the CRC 3 level; coordinators who have not yet obtained it will not meet the CRC 3 Core Qualification threshold regardless of performance. 

• Demonstrated knowledge of ICH GCP, IRB and FDA clinical research requirements, HIPAA/privacy, safety reporting obligations, and essential document standards, verified through current CITI certification (GCP and Human Subjects tracks, renewed per institutional schedule) and observed independent performance on assigned studies. 

• Proficiency in source documentation, ALCOA+ principles, EDC/CRF completion, query resolution, regulatory file maintenance, and research systems. Demonstrated independent proficiency across all assigned research systems. 

• Ability to identify risk, analyze recurring problems, support corrective actions, and communicate clearly with the PI and leadership. 

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Bachelor’s degree in relevant field

Minimum 3 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.
• Commitment to the University’s core values.
• Ability to work independently and/or in a collaborative environment.