Clinical Research Coordinator , Pediatrics

Clinical Research Coordinator 1, Pediatrics

The Department of Pediatrics at the University of Virginia School of Medicine is seeking a Clinical Research Coordinator 1 (CRC
1), Non-Licensed to support clinical research within the MD Clinic within the Division of Neurodevelopmental and Behavioral Pediatrics. The MD Clinic provides multidisciplinary care to children and young adults with muscular dystrophy and other neuromuscular conditions. The clinic's research portfolio includes observational studies, clinical trials, investigator-initiated studies, registries, and federally or externally funded research focused on understanding disease progression, evaluating new and emerging therapies, assessing functional outcomes, and improving patient care.

Although this position is based within the Division of Neurodevelopmental and Behavioral Pediatrics, the CRC will primarily support research activities associated with the MD Clinic. The CRC will work closely with Principal Investigators, physicians, advanced practice providers, therapists, research staff, and other members of the multidisciplinary clinical and research teams. The Clinical Research Coordinator will support the day-to-day coordination and conduct of clinical research involving children, young adults, and their families.

This position combines direct interaction with research participants and families with study coordination, data collection and management, regulatory compliance, and clinical research administration.

Responsibilities Under the guidance of experienced clinical research staff and Principal Investigators, the Clinical Research Coordinator 1 will:

• Assist with the day-to-day coordination of clinical research studies within the MD Clinic.
• Work collaboratively with Principal Investigators, research staff, physicians, advanced practice providers, therapists, and other members of multidisciplinary research and clinical teams.
• Support participant recruitment, including identifying and pre-screening potential participants through approved recruitment methods and medical record review.
• Communicate with children, young adults, and parents or caregivers regarding potential research participation, study visits, scheduling, and study requirements.
• Assist with participant screening and enrollment and, following appropriate training and authorization, participate in informed consent and assent processes.
• Coordinate study visits and protocol-required activities, including scheduling appointments, assessments, procedures, and follow-up visits.
• Assist with the administration and coordination of research assessments, questionnaires, surveys, interviews, and other study procedures following appropriate training.
• Create and maintain study materials, including visit checklists, source documents, participant materials, tracking tools, study calendars, and research records.
• Collect and maintain accurate research data and source documentation in accordance with study protocols, institutional policies, and Good Clinical Practice (GCP).
• Enter and maintain study data in electronic databases and data capture systems and assist with resolving data queries.
• Maintain participant tracking logs, regulatory documents, study files, and other essential research documentation.
• Support preparation and submission of study materials to the Institutional Review Board (IRB) and assist with maintaining ongoing regulatory compliance.
• Assist with tracking and documenting adverse events, protocol deviations, and other study-related information and promptly communicate concerns to the Principal Investigator and/or supervising research staff.
• Support study start-up activities, amendments, continuing reviews, study close-out, and other activities throughout the research lifecycle.
• Assist with sponsor or research-network meetings, monitoring visits, audits, and other study-related activities as applicable.
• Communicate professionally, respectfully, and compassionately with research participants and families, including individuals with a wide range of physical, developmental, communication, and support needs.
• Collaborate with clinical teams and other departments to coordinate research activities while minimizing burden on participants and families.
• Develop proficiency with clinical research and data systems used by UVA and external research partners, which may include Epic, OnCore, IRB Pro, Protocol Builder, REDCap, and other electronic data capture and study-management systems.
• Develop knowledge of federal regulations, institutional policies, Good Clinical Practice, and other requirements governing human subjects research, including research involving children and other potentially vulnerable populations.
• Complete required clinical research training and actively participate in ongoing professional development and mentorship.
• As knowledge and experience increase, assume progressively greater responsibility for assigned research activities under appropriate supervision.
• Perform other duties as assigned.

Position…