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Position Summary
The primary purpose of this position is to coordinate and support our pediatric research initiatives according to regulatory requirements, institutional guidelines, and sponsor expectations in Pediatric Critical Care. Duties include initiating new research studies, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, and responding to data queries. This position reports to the Clinical Research Project Manager, but is accountable to the program leaders, the physician-investigators, and members of the research team.
Responsibilities
Clinical Research Conduct & Facilitation (90%)
Coordinate all study-related activities, including participant recruitment, enrollment, study visits, data and specimens, and sponsor visits
Act as information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue.
Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.
Facilitate the timely review and reporting of adverse reactions and severe adverse events
Contribute to the production of research publications or presentations of research data
Research Regulatory Management (5%)
Partner with Regulatory Specialist to ensure regulatory binders compliance for assigned studies
Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
Report Unanticipated Problems according to University policy
Education and Administration (5%)
Educate others of our regulatory and research obligations in relation to our clinical research activities
Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
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