Clinical Research Coordinator 1/2, Pediatrics

Socket.dev; Charlottesville (VA); On-site; USD 54,000 - 65,000; Full time

Job summary

The University of Virginia Health System in Charlottesville, VA, is seeking a Clinical Research Coordinator 1 or 2 (CRC 1-2), Non-Licensed, to support NIH, industry-sponsored, and investigator-initiated studies in pediatrics.

This on-site role focuses on coordination, data management, regulatory compliance, and participant interactions for studies related to eating disorders in adolescents and young adults. Training is provided, with mentorship and growth opportunities within UVA Health.

Qualifications

• Bachelor's Degree required or equivalent combination of experience, education and or certifications.
• CRC 1: experience in a healthcare setting preferred but not required.
• CRC 2: at least one year of clinical research experience preferred.

Responsibilities

• Coordinate day-to-day management of clinical research studies with PIs and teams.
• Assist with regulatory documents, study materials and startup activities.
• Support recruitment, screening, enrollment and informed consent.
• Manage data collection, entry and queries in study systems.
• Prepare materials for IRB submissions and sponsor monitoring visits.

Education

Bachelor's Degree

Job description

The Department of Pediatrics at the University of Virginia School of Medicine is seeking a Clinical Research Coordinator 1 or 2 (CRC 1-2), Non-Licensed to support clinical research conducted by the Pediatrics Department Chair and other faculty within the Department as needed.

The CRC will assist with the coordination of National Institutes of Health (NIH)-funded, industry-sponsored, and investigator-initiated clinical research studies. The individual will work closely with Principal Investigators, clinical research staff, faculty, advanced practice providers, nurses, and other members of the clinical and research teams. The CRC will primarily work on clinical research related to eating disorders in adolescents/young adults.

This is an excellent opportunity for an individual interested in developing a career in clinical research. The CRC 1 will receive training and mentorship while gaining experience across the full lifecycle of clinical research studies. Responsibilities will include participant-facing activities, study coordination, data collection and management, regulatory compliance, and clinical research administration.

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 our multidisciplinary teams and play an essential role in bringing new discoveries into clinical practice.

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 and work closely with Principal Investigators and other study team members.
• Support study start-up activities, including collection and preparation of regulatory documents, study materials, and other required documentation.
• Assist with the creation and maintenance of study tools, including visit schedules, source documents, participant diaries, study checklists, training logs, equipment records, and study communications.
• Support participant recruitment efforts, including identification and pre-screening of potential research participants.
• Assist with screening and enrollment activities and, following appropriate training and authorization, participate in the informed consent process.
• Coordinate participant study visits and protocol-required activities, including scheduling appointments and procedures and communicating with participants and members of the clinical care team.
• 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 internal and external electronic data capture systems and respond to data queries with guidance from senior research staff.
• Assist with the collection, processing, preparation, storage, and shipment of research specimens according to study protocols and applicable requirements.
• Maintain study records, participant tracking logs, regulatory documents, and other essential research documentation.
• Assist with tracking concomitant medications, adverse events, protocol deviations, and other study-related information and promptly communicate concerns to the Principal Investigator and/or supervising research staff.
• Support preparation and submission of materials to the Institutional Review Board (IRB) and other regulatory or oversight bodies as appropriate.
• Assist with sponsor and CRO monitoring visits, site initiation visits, audits, and other study-related meetings and activities.
• Communicate professionally with study participants, investigators, sponsors, CROs, clinical teams, and other departments involved in research activities.
• Assist with tracking participant payments and research-related clinical activities and charges.
• Develop proficiency in clinical research systems used by UVA and external sponsors, which may include Epic, OnCore, IRB Pro, Protocol Builder, REDCap, iMedidata, Inform, OpenClinica, and other electronic data capture and study-management systems.
• Develop knowledge of federal regulations, institutional policies, Good Clinical Practice, and other requirements governing the conduct of human subjects research.
• Complete required clinical research training and actively participate in ongoing professional development, mentorship, and educational opportunities.
• As knowledge and experience increase, assume progressively greater responsibility for assigned study activities under appropriate supervision.
• Perform other duties as assigned.

MINIMUM REQUIREMENTS

CRC 1 non-licensed

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.

Licensure: None.

Anticipated hiring range: $25-27 hourly (non-exempt), commensurate with education and experience.

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.

Licensure: None.

Anticipated hiring range: $60,000-65,000 annual (exempt), 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.

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 screenings 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.

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.