Clinical Research Coordinator 2/3, Pediatrics

UVA Health•Charlottesville, VA

3d•$60,000 - $77,000•Onsite

About The Position

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. The research portfolio consists primarily of industry-sponsored clinical trials, as well as registries and investigator-initiated studies involving children and young adults with congenital and acquired cardiovascular disease, inherited cardiovascular conditions, cardiomyopathies, arrhythmias, pulmonary hypertension, heart failure, transplantation, and other rare or complex cardiovascular disorders. Studies may include investigational drugs, biologics, medical devices, genetic testing, and other novel therapeutic interventions. The Clinical Research Coordinator will work closely with Principal Investigators, physicians, geneticists, genetic counselors, research staff, sponsors, contract research organizations (CROs), and multidisciplinary clinical teams to support the conduct of clinical research studies from study start-up through study close-out and archival activities. This position offers the opportunity for hiring at either the CRC 2 or CRC 3 level. Classification will be determined based on the candidate's education, experience, certification status, and demonstrated clinical research competencies consistent with the UVA Clinical Research Coordinator career ladder. The scope of responsibilities, complexity of assigned studies, and degree of independent responsibility will vary based on the level at which the successful candidate is hired. CRC 2 staff perform research activities with guidance and oversight from experienced research personnel, while CRC 3 staff are expected to coordinate more complex studies and perform assigned responsibilities with greater independence.

Requirements

Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
At least one year of clinical research experience (for CRC 2).
Minimum of 3 years of clinical research experience required (for CRC 3).
Master’s degree may substitute for 1 year of clinical research experience (for CRC 3).
Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year (for CRC 3).

Nice To Haves

Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year (for CRC 3).

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.
Coordinate and schedule research visits and protocol-required study activities.
Assist with and/or coordinate study conduct activities, including participant tracking, medication documentation, safety reporting, study payments, and follow-up procedures.
Coordinate 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.
Assist 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.
Assist with research billing compliance activities, including identifying research-related services and supporting study billing reconciliation processes.
Support sponsor invoicing, reimbursement tracking, and study financial documentation as appropriate.
Assist 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.