Nationwide Children's Hospital·Columbus, Ohio
Manages clinical study elements including recruitment, enrollment, and day-to-day management following ICH/GCP guidelines. Responsible for collecting research data, processing human specimens, and maintaining regulatory binders.
The Center for Surgical Outcomes Research (CSOR) seeks an energetic and collaborative applicant to serve as a Clinical Research Coordinator (CRC).
The CSOR is part of the Center for Child Health Equity and Outcomes Research (CCHEOR) at the Abigail Wexner Research Institute at Nationwide Children’s Hospital.
CSOR is a national leader in clinical and health services research related to the surgical care of children.
CSOR provides a comprehensive research program that employs a wide range of methodologies to perform rigorous clinical and health services research.
The desired CRC will serve alongside a multidisciplinary team of surgeons, biostatisticians, epidemiologists, research staff, and research trainees to improve the delivery and outcomes of surgical care for children.
Job Description: Summary:
Manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.
Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
Collects and manages research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures.
Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours.
Completes screening sheets and recruitment logs.
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.
Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I.
Adheres to departmental quality control guidelines.
Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits.
Maintains regulatory binder and documents.
Previous experience in clinical research or health care related field preferred.
Occasionally: Cold Temperatures, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel
"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"
Market context
In Ohio, Clinical Research Coordinator I roles often appear at hospitals, academic medical centers, and research sites supporting studies across multiple specialties. Competition can be stronger for candidates with an Associate's degree plus CNA, PCA, LPN, or MA certification, since a Bachelor's degree and prior healthcare or clinical research experience are often preferred. Review the AI-summarized requirements and benefits on this platform to save time, then match your clinical background to the study coordination, documentation, and patient-facing duties before applying.
