Clinical Research Coordinator 2/3, Pediatrics

The Rector & Visitors of the University of Virginia; Charlottesville (VA); On-site; USD 60,000 - 77,000; Full time

Job summary

The University of Virginia (The Rector & Visitors of the University of Virginia) seeks a Clinical Research Coordinator (CRC), Non-Licensed, at CRC 2 or CRC 3 levels to support pediatric cardiology and cardiovascular genetics studies. Responsibilities span start-up to close-out, working with PIs, physicians, geneticists, and CROs on industry-sponsored trials, registries, and investigator-initiated studies.

CRC2/CRC3 levels offer different independence and complexity; salary ranges reflect level

Qualifications

• Bachelor's Degree required or equivalent combination of experience, education and/or certifications.
• CRC2 requires at least 1 year of clinical research experience; CRC3 requires a minimum of 3 years.

Responsibilities

• Screen electronic medical records and other approved sources to identify potential research participants.
• Recruit, screen, consent/assent, enroll, and retain research participants per protocols.
• Coordinate and schedule research visits and protocol-required activities.
• Maintain communication with participants and families during study participation.
• Coordinate protocol-required procedures including laboratory and imaging.
• Collect, enter, and manage study data; respond to data queries.
• Prepare regulatory submissions and documentation for IRB review and approvals.
• Ensure study compliance with GCP, safety reporting, and regulatory requirements.

Job description

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. [hr.virginia.edu]

About the Department

The Department of Pediatrics at UVA Health is committed to improving the health and well-being of children through excellence in patient care, education, research, and advocacy. Pediatric investigators conduct innovative clinical, translational, and population health research aimed at advancing care for children and families. Research staff are valued members of multidisciplinary teams and play an essential role in bringing new discoveries into clinical practice.

Responsibilities

Responsibilities may include the following. Duties assigned will be commensurate with the employee's classification, experience, training, and demonstrated research competencies.

• 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.

MINIMUM REQUIREMENTS

CRC 2 non-licensed

Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.

Experience: 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

Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.

Experience: 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.

PHYSICAL DEMANDS

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.

This is an exempt-level, benefited position. Learn more about UVA benefits.

This is a restricted position, which is dependent on funding and is contingent upon funding availability.

This position is based in Charlottesville, VA, and must be performed fully on-site.

About UVA and the Community

To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA.

Additional Requirements

Background checks, pre-employment health screenings, and drug screening's will be conducted on all new hires prior to employment.

This position will not consider candidates who require immigration sponsorship now or in the future.

Reference Check Process

Reference checks will be completed by UVA's third-party partner, SkillSurvey, during the final phase of the interview. Five references will be requested, with at least three responses required.

The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA's commitment to non-discrimination and equal opportunity employment.