| The primary purpose of this position is to support numerous new clinical research projects according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, 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 Research Project Manager, but is accountable to the physician-investigators, program leaders, and members of the clinical research team.
Responsibilities:
Research Project Coordination (60%)
• Independently manage a large and complex portfolio of research projects.
• Data management for multiple pediatric endocrinology projects, including:
o Database development
o Data collection
o Ensuring data quality
o Developing summary reports
• Inform and coordinate the development of a long-term follow-up research project in pediatric endocrinology
• 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, and ensuring compliant completion of research activities.
• 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 (25%)
• Ensure overall regulatory compliance for a large and/or complex portfolio of research projects
• Serve as the primary contact for the completion of required regulatory documentation
• Prepare regulatory approval applications; respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained. Track all regulatory review submissions to ensure deadlines are met.
• In collaboration with the PI, interpret study protocols and develop consent form documents needed for each clinical research study
• Maintain regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time
• Provide regulatory guidance and direction to all members of the research team to ensure compliance with applicable policies, procedures, and regulations
• Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
• Report Unanticipated Problems according to University policy
Administration (10%)
• Facilitate new project development and start-up activities
• Support quality improvement initiatives
• Facilitate Pre-award and Post-award grant administration
• Attends national and study meetings as appropriate
Education (5%)
• Support the training and mentoring of CRCs within the program and across Pediatrics
• Educate University faculty and staff 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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