Clinical Research Coordinator 2/3, Pediatrics

About the role

The Department of Pediatrics at the University of Virginia School of Medicine seeks applicants for a Clinical Research Coordinator (CRC), Non-Licensed, at either the CRC 2 or CRC 3 level, to support a growing portfolio of clinical research studies within Pediatric Cardiology and Cardiovascular Genetics.

Responsibilities

• Work closely with Principal Investigators, research team members, and clinical partners to support assigned clinical research studies.
• Screen electronic medical records and other approved sources to identify potential research participants and track recruitment activities.
• Recruit, screen, consent/assent, enroll, and retain research participants in accordance with study protocols and delegated responsibilities.
• Maintain telephone, electronic, and in-person communication with research participants and families throughout study participation.
• Coverage of study conduct activities, including participant tracking, medication documentation, safety reporting, study payments, and follow-up procedures.
• Coordinate and schedule research visits and protocol-required study activities.
• Assist with and/or coordinate study conduct activities, including protocol-required clinical and research procedures, which may include laboratory testing, imaging studies, cardiac testing, genetic testing, investigational products, and other study-specific assessments.
• Collect participant data and maintain study records, logs, source documentation, and research files.
• Perform timely and accurate data entry into internal and external electronic systems and respond to sponsor and study data queries.
• Collect, process, prepare, store, track, and ship biological specimens according to protocol and institutional requirements.
• Maintain awareness of participant safety, protocol compliance, and study progress and communicate concerns to the Principal Investigator and/or supervisor.
• Communicate effectively with study sponsors, CROs, research networks, institutional partners, and other external collaborators.
• Demonstrate knowledge of Good Clinical Practice (GCP), human subjects protections, and applicable federal, state, sponsor, and institutional requirements governing clinical research.
• Auxiliary with and/or coordinate study start-up activities, including feasibility assessments, regulatory submissions, essential document preparation, sponsor communications, and study activation processes.
• Coordinate one or more clinical research studies simultaneously, including studies that may be longitudinal, multicenter, industry-sponsored, or otherwise complex in nature.
• Support ongoing study conduct activities from participant enrollment through study completion and close-out.
• Prepare regulatory submissions and study documentation, including materials for IRB review, protocol modifications, continuing reviews, personnel changes, reportable events, and study closure activities.
• Identify, document, and facilitate timely reporting of adverse events, serious adverse events, protocol deviations, and unanticipated problems as required.
• Coordinate and participate in sponsor qualification visits, site initiation visits, monitoring visits, audits, investigator meetings, and study close-out activities.
• Maintain complete, accurate, and audit-ready regulatory and study documentation.
• Collaborate with departments and services outside of Pediatrics, including Pharmacy, laboratory services, imaging teams, procedural areas, and other clinical and research groups, to support study implementation.
• Auxiliary with research billing compliance activities, including identifying research-related services and supporting study billing reconciliation processes.
• Auxiliary with the orientation and training of research personnel, students, and new study team members as appropriate and consistent with level of experience.
• Demonstrate proficiency with research-related electronic systems such as Epic, REDCap, OnCore, CRConnect, IRB Pro, Protocol Builder, sponsor electronic data capture systems, and electronic regulatory platforms.
• Participate in the development and improvement of study workflows, source documents, tools, and operational processes to support efficient and compliant clinical research.
• Demonstrate increasing levels of clinical research knowledge, competency, and independence through participation in required training programs, continuing education activities, mentorship opportunities, and professional development initiatives.
• Perform other duties as assigned.

Requirements

• CRC 2 non-licensed: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred. Anticipated hiring range: $60,000-65,000 annual, commensurate with education and experience.
• CRC 3 non-licensed: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Minimum of 3 years of clinical research experience required. Master’s degree may substitute for 1 year of clinical research experience. Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year. Anticipated hiring range: $69,000-77,000 annual, commensurate with education and experience.