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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,…