Clinical Research Coordinator 1

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 1 to work at our UHealth Medical Campus.  The CRC1 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 JOB FUNCTIONS
1. Performs chart review/pre-screening activities for study participant eligibility and coordination of simple
clinical research protocols. Maintains enrollment procedures according to the protocol.
2. Coordinates routine activities of clinical studies including data collection and maintenance, planning study
timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
3. Performs moderate to complex research tests/ experiments and adapts procedures for quality
improvement under supervision.
4. Understands and follows technical instructions for operating clinical research equipment, problem solves
when operational failures occur.
5. Assists in observing and informing the PI/supervisor of adverse events, including those reported by study
participants.
6. Addresses adverse events per protocol, advocating for study participants and quality standards
throughout the lifespan of the study.
7. Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
8. Follows the appropriate fundamental requirements of all international, national, and local regulatory
bodies.
9. Knows the contents and maintenance of study-specific clinical research regulatory binders.
10. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research,
continuing education, and research competencies.
11. Adheres to University and unit-level policies and procedures and safeguards University as

Department Specific Functions

• Assist the study investigators and work collaboratively in the preparation of IRB, NIH and other organization regulatory compliance reports.
• Perform study-related tasks including participant recruitment and scheduling, administration of all measures, screening tools, intervention operationalization, and lead retention efforts.
• Maintain and expand collaborative relationships with cancer clinics, physicians, and nurses and Sylvester Comprehensive Cancer Clinic.
• Providing research support to Principal Investigators assisting with maintenance of databases, coordinating biweekly research meetings, assisting with literature reviews/searches and manuscript preparation.
• Facilitate sample processing and storage.
• Oversee CITI-training in the Protection of Human Participants and OSHA-mandated training related to the handling of physiological specimens.
• Bilingual in English and Spanish required.

This list of duties and responsibilities is not intended to be all-inclusive and may be ex