Clinical Research Coordinator 1

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The University of Miami/UHealth Department of Public Health has an exciting opportunity for a full time Clinical Research Coordinator 1 to work in Miami, FL.

The Clinical Research Coordinator 1 will primarily work coordinating a study funded by the American Cancer Society and a multi-site study funded by the National Cancer Institute. The goal of the study funded by the American Cancer Society is to develop and test a cognitive behavioral intervention (Acceptance and Commitment Therapy) to improve emotional wellbeing among Spanish-speaking Latina women living with metastatic breast cancer. The goal of the study funded by the National Cancer Institute is to prospectively characterize treatment side effects/toxicities and quality of life among 416 diverse individuals with metastatic cancer who are starting an immune checkpoint inhibitor (a form of immunotherapy). 

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.

Department Specific Functions:     

• Contribute to applied research activities by recruiting, collecting and analyzing data, maintaining databases, etc.  
• Understand and interpret research protocols and procedures for the project  
• Assist with developing, maintaining, and implementing standard operating procedures for the project 
• Carry out research activities in accordance with research protocols  
• Assist/coordinate day-to-day and large-scale study management 
• Assist/coordinate meetings among research team (internal and external) and prepare agenda for meetings   
• Assist with study start-up/preparing research materials (i.e., data collection instruments/study documents) 
• Assist with REDCap setup and managing REDCap data 
• Assist with coordinating and scheduling on-site visits with organizations  
• Assist with (and in some cases lead) on-site data collection: field observation notes/jottings, formal and informal interviews, reviewing strategy workflows/SOPs  
• Assist with data collection debriefs with PI and delegate of PI  
• Assist with qualitative data analyses and data integration (directed by PI and delegate of PI)  
• Assist with and conduct literature reviews  
• Coordinate and facilitate interviews and focus groups 
• Assist/coordinate recruitment efforts for implementers and organizations  
• Assist with ACS and NIH progress reports and UM sponsored award reports  
• Collaborate with PI, collaborators, and other staff to publish findings in refereed journals 
• Complete weekly individual meetings with supervisor and prepare detailed agendas for meetings (as needed)  
• Lead or supervise extraction of clinical data from the EHR/EMR
• Advance knowledge related to job duties through continued education, training and/or research, as assigned by superv