Nationwide Children's Hospital · 1 month ago
Clinical Research Coordinator II - RI Gene Therapy
Main Campus, Columbus, OH
Full-time
Onsite
Entry, Mid Level
1+ years expNationwide Children's Hospital is a leading healthcare provider focused on pediatric care. The Clinical Research Coordinator II is responsible for managing clinical studies, ensuring adherence to protocols, and training other coordinators while prioritizing subject safety and regulatory compliance.
ChildrenHealth CareMedical
Responsibilities
Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices
Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate
Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies
Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success
Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination
Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection
Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF’s) and ensures CRF’s are completed prior to monitor visits
Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training
Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination
Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder
Assists the principal investigator in the preparation of scientific publications and grant proposals
Qualification
Required
Associate's degree or equivalent work-related experience, required
Eighteen months experience in clinical research or health care field, required
Preferred
BA/BS, preferred
CRA/CRC certification, preferred
Understanding of medical terminology and clinical trials preferred
Working knowledge of PCs and word processing and data management software
Demonstrated analytical skills with accuracy and attention to detail
Excellent verbal and written communication skills
Goal-oriented and self-directive, ability to manage complex projects independently
Strong organizational and interpersonal skills
Ability to actively participate as a team player
Company
Nationwide Children's Hospital
Nationwide Children’s, we are creating the future of pediatric health care. We consider every detail. Every decision. Every aspect
10001+ employees
H1B Sponsorship
Nationwide Children's Hospital has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (24)
2023 (22)
2022 (16)
2021 (14)
2020 (16)
Funding
Current Stage
Late StageTotal Funding
$4.1MKey Investors
National Institute of Neurological Disorders and StrokeNational Heart, Lung and Blood Institute
2024-03-04Grant· $4.1M
2023-09-19Grant
Leadership Team
Chet Kaczor
Senior Vice President Operations
Recent News
2026-01-03
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