Clinical Research Coordinator 1, Pediatrics

About the role

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.

Responsibilities

• Assist with the day-to-day coordination of clinical research studies within the MD Clinic.
• Collaborate 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.
• Aid in participant screening and enrollment and, following appropriate training and authorization, participate in informed consent and assent processes.
• Carefully coordinate study visits and protocol-required activities, including scheduling appointments, assessments, procedures, and follow-up visits.
• Aid in 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.
• Accurately collect and maintain 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.
• Aid in 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.
• Aid in study start-up activities, amendments, continuing reviews, study close-out, and other activities throughout the research lifecycle.
• Aid in 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.

Qualifications

• Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
• Experience: None. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
• Preferred Qualifications: Academic background or experience in psychology, neuroscience, child development, human development, public health, kinesiology, exercise science, health sciences, education, or a related field.
• Experience working with children, young adults, and/or families.
• Experience with or demonstrated interest in working with individuals with pediatric neuromuscular disorders, muscular dystrophy, rare diseases, or complex pediatric medical conditions.
• Interest in developing a career in clinical research, neuromuscular medicine, or a related field.
• Strong interpersonal skills and the ability to build rapport with children, young adults, and families.
• Ability to communicate effectively and respectfully with individuals with varying physical abilities, communication styles, developmental abilities, and support needs.
• Strong organizational skills and attention to detail.
• Ability to manage multiple responsibilities and priorities while maintaining accurate documentation.
• Strong written and verbal communication skills.
• Ability to work effectively both independently and as part of a multidisciplinary team.
• Demonstrated reliability, initiative, professionalism, flexibility, and willingness to learn.
• Experience with medical records, data collection, databases, research, or healthcare environments is beneficial but not required.