Clinical Research Coordinator 1/2, Pediatrics

UVA Health•Charlottesville, VA

2d•$52,000 - $65,000•Onsite

About The Position

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.

Requirements

Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
None (for CRC 1).
At least one year of clinical research experience (for CRC 2).
Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
None (for CRC 1 and CRC 2).

Nice To Haves

Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Responsibilities

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.