Job Description

The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work onsite on the UHealth campus. The Clinical Research Coordinator 1 serves as an entry-level clinical research professional that has a foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. The incumbent is responsible for simple clinical research protocols and timelines. Core job functions include performing chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols, maintaining enrollment procedures according to the protocol, coordinating routine activities of clinical studies including data collection and maintenance, planning study timelines, scheduling 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. Department specific functions include reviewing medical records of patients at the University of Miami and Jackson Memorial Hospital for clinical research studies, entering abstracted data from the medical record into structured RedCap data form or other electronic data capture system, serving as research coordinator for multiple NIH-sponsored clinical trials, maintaining study files according to protocol requirements, UM and department policy, recruiting and screening participants, obtaining informed consent, and following participants according to study calendar. Ensures study medication is kept secure and under the appropriate temperature condition and maintains accurate study drug accountability. Ability to work independently and/or in a collaborative environment. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations. Prepares IRB submissions including continuing reporting, reportable events, amendments and follow ups to IRB. Helps obtain patient specimens (e.g., blood) to be stored and shipped to the central research laboratory. Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Responsible for ordering and maintaining stock of necessary supplies. Assists with study orientation and protocol related in-services to research team and clinical staff. Supports multiple liver disease research studies by performing a variety of duties. Bilingual (English and Spanish) preferred. Performs other duties as assigned by the PI. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. Core qualifications include a Bachelor’s degree in relevant field and minimum 1 year of relevant experience. Knowledge, skills and abilities include learning agility, teamwork, technical proficiency, and strong communication skills. 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 is South Florida's only university-based health system providing leading-edge patient care powered by groundbreaking research and medical education at the Miller School of Medicine. The University of Miami is an Equal Opportunity Employer.

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