Clinical Research

• Participate in the development, coordination, monitoring, and implementation of research strategies for clinical trials
• Perform documentation, tracking, data abstraction and collection
• Work with Pharm D on dosage and titration of study drug
• Manage drug treatment schedules
• Educate nurses regarding studies/trials with participating children
• Attend clinical coordinator meetings
• Assure that patient visits are scheduled accordingly
• Collaborate with principal investigators to resolve implementation problems
• Educate patients and/or family members about study requirements
• Participate in recruitment of potential protocols for activation
• Review and discuss clinical procedures within the unit with new employees

Clinical Research Coordinator – Department of Pediatrics

• Support site start‑up activities, including feasibility assessments, regulatory document collection, and staff registration with sponsors.
• Maintain communication channels and contact lists for all network affiliates.
• Provide training and ongoing support to site personnel; assist in developing training tools and job aids.
• Coordinate network meetings, teleconferences, agendas, and minutes.
• Track site performance, protocol status, and accrual metrics.
• Assist with contracting processes, including site agreements, work orders, and regulatory submissions.
• Collaborate with website and communications teams to maintain timely updates.
• Ensure adherence to study protocols, IRB requirements, and federal/state regulations.
• Oversee data collection, data quality review, and reporting for the regional locations.
• Maintain regulatory documentation, deviation/violation tracking, and staff credentialing and training.
• Communicate with sponsors, NCTN groups, and investigators throughout the project lifecycle.
• Assist with eligibility review, enrollment processes, and participant follow‑up as needed.
• Conduct remote or on‑site study start up meetings, monitoring visits and prepare follow‑up documentation.
• Work with Informatics teams to implement workflows and data systems.
• Prepare project status reports for leadership and stakeholders.
• Develop tools, workflows, and tracking systems to support project and network operations.
• Assist in creating educational materials and resources to support clinical trial awareness.
• Contribute to SOP development and process improvement initiatives.
• Coordinate research team meetings and administrative tasks.
• Expected to provide training, guidance, and support to research staff. May serve as project or program lead as assigned.

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Clinical Research Coordinator – Department of Pediatrics

Research Network & Project Coordinator